Audit report
for
Rofil Medical Nederland BV
(formerly: Rofil Medical International NVj
Heusing 16
4817 ZB Breda
Netherlands
Thb TÜV Rheinland Product Safety GmbH report repaces the prevlous report with report no 21 104G0Q007 (TRPS) en
no. 30592855002 Version 2 (TRNA)
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Berfln Brandenburg
Table of Contents
Page
1 SUrllnlary
3
2 Objectives and basis of the audit_m
5
3 Scope
6
4 Audit process and fîndings
7
7
4i Audit process
42Findings
15
5 Concusion
16
6 Comment and remarks,
17
7 Genera! n otes
18
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1 Summary
Holder of certificatel
approval
Place of audit
:
Auditee’s Representative:
Order Number
:
Directive
:
Rofil Medical Nederland BV.
(formerly: Rofil Medical International N.Vj
Heusing 16
481 7ZB Breda
Netherlands
Rofil Medical Nederland B.V.
Heusing 16
NL4BI7ZB Breda
Netherlands
1024770
Medical Device Directive 93/42/EEG, Annex 113
Active Implantable Medical Davices 90/385/EEG, Annex no.
fl
Standards appiled
:
In Vitro Diagnostic Medical Devices 98/79/EG, Annex no,
EN ISO 9001:2000
EN ISO 13485:2003
ISO 13485:2003 (under CMDCAS)
Type of Audit
:
U
Date of Âudit
:
Pre Audit
3. Surveillance / Foliow-up Audit
Certification Audit
Re-certification Audit
Repeat Audit
1. Surveillance ISO 13485:2003 uncter
CMDCAS
25,26. October 2006
Lead Auditor
Auditor(s)
:
Summary
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Audit Report
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TUV Rheinland
Barlin Brandenburg
Duo to new aspecta of the certlficatlon status of the new suppller PROCYTECH the present 70V Rheinland Product
Safety GmbH report no. 21 1O460O...OO8 (TRPS) and no. 30692855_002 Verslon 3 (TRNA) replaces the prevlous report
no. 21104600_007 (TRPS) and no. 30592855_002 Verslon 2 (TRNA).
Within the scope of the audit, the company has fumished proof that It maintains a quality system in accordance with Directive
93!42JEEC and that the requirements of the above mentioned standards are fulfihled.
Therefore, ii is recommended that the TCJV Rheinland Product Safety GmbH Notified Body (0197) approval (1W 60009358
0001) should remain vad. Furtherniore It is recommended that the TÜV Rheinland Product Safety GmbH certificates
according to EN ISO 9001:2000 (SY 60014115 0001) as well as according to EN lSO 13485:2003 (SX 60014114 0001)
should remain valid.
Additionally, It Is recommended that the TÜV Rhelnland of North America, mc. quality system certificate to ISO 13485:2003
under CMDCAS shouki remain valid (registration no.: 745002332).
The company did not add any new products during the surveillance period (MDD 93/42/EEG) into the European Market,
whlch are under the surveillance of TÜV Rhelnland Product Safety GmbH.
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The following pages coritain more t
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t7-C’.fi
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ObJectlves and basis of the audit
The TÜV Rheinland Product Safety was cortracted by Rofil Medical International N.V. (RMI),
now renamed into Rofil Medical Nederland B.V. (RMN), in Breda (Netherlands) to perform the
3. Surveillance Audit.
Note: Historically TÜV Rheinland Product Safety was contracted by Rofil Medical International
NV. (RMI). Nevertheless after the audit Rofil Medical International N.V. (RMI) applied to change
the company name into Rofil Medical Nederland B.V. (RMN) In June 2007.
In this report both company names RMI and RMN are used but should be considered to be the
same company.
The current scope of the approval and certificate issued by TÜV Rheinland Product Safety is
“Design, Manufacturing and Distribution of non-active implantable Medicals Devices”.
TUV Rheinland of North America was contracted by Rofil Medical International N.V, (RMI) to
perfom-i the 1. Surveillance Audit to ISO 13485:2003 under CMDCAS.
Rofil Medical International is a “private label” manufacturer and selis only devices, which are
manufactured and purchased by the suppliers.
In June 2007, Rofil Medical International N.V. (RMI) applied for a change of the company name
into Rofil Medical Nederland B.V. (RMN).
Due to the name change the certifïcates have to be rewritten.
•
•
•
The company name of the TÜV Rheinland Product Safety certificates needs to be
changed (HD 60009358 0001, SY 60014115 0001 as well as SX 60014114 0001).
In addition the address of the company name for the Smooth, micro-textured and
textured high cohesivity gel pre-filled breast implants (ID 60008171 0001) needs to be
revised.
The company name of the TUV Rheinland of North America certificates needs to be
changed (ISO 13485:2003 under CMDCAS).
The basis of the audit was as follows:
• Directive 931421EEC, Annex 11.3
• ISO 13485:2003 underCMDCAS
• EN ISO 9001:2000
• EN lSO 13485:2003
• Quality assurance manual (QA manual) QM 00.01, revision M
• Procedures, work instructions, formsheets as listed on QM 00.02 Rev E, dated 14. July 2006
• Selected standards, e.g. EN ISO 14971:2000, EN 980:2003 and further
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The purpose of the audit was to verify, that the above mentioned requirements are fulfilled.
Changes to the approved quaty system documentation were reviewed during the surveiUance
audit and found to be acceptable.
3
Scope
The 3. Surveillance Audit refers to the quality management system of Rofil Medical International
N.V. with regard to the activities for “Design, Manufacturing and Distribution of non-active
implantable Medical Devices” (HD 60009358 0001) issued by TÜV Rheinland Product Safety
GmbH. The scope of the certificates refers to smooth, micro-textured and textured high
cohesivity gel pre-filled breast implants.
The Design Dossier for the breast implants was already reviewed by the TÜV Rheinland Product
Safety GmbH for compliance to the requiremerits of Annex 11.4 of Directive 93/42/EEG and
2003/1 2!EEC. An approval for the “Smooth, micro-textured and textured high cohesivity gel pre
filled breast implants” has been issued by TÜV Rheinland Product Safety GmbH. The approval
number is ID 60008171 0001 (expiry date 14. March 2009). The breast implants are only sold in
Europe and not in Canada. Therefore no device licence had been applied for.
The product “Smooth, micro-textured and textured high cohesivity gel pre-filled breast implants”
is manufactured by POLY IMPLANT PROTHESES (PIP) 337 Ave. De Bruxelles B.P. 429
83514 La Seyne-Sur-Mer (France). The competence of the subcontractor PIP can be
demonstrated by the TUV Rheinland Product Safety GmbH MDD 93!42IEEC Annex 11.3
certifîcate and MDD 93/42/EEG Annex 11.4 approval for the medical device.
-
,
-
The audit included the areas specified in the audit plan. At the moment, the number of
employees is 13 The employees interviewed during the audit are anciuded in an interview list
fr’i i idif rnnrf
The Q-Manual for RMI was adapted to include the new company name RMN.
Medical device responsibilities are referenced in the document PRO 02.02.01.
The following areas/departments had been audited:
(President)
• General Management/Int. Sales Mr.
•
General Management/Sales/Human resources Mr.
•
Finance/Administration
Mr.
•
Quality Management
Mrs.
•
Safety issues/regulatory
Mrs.
•
Research & Development
Mrs.
•
Warehouse/Quality Control
Mr.
•
Çi,qtnm’r rvirø
Mr
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The audited departments and their processes, as well as the audited personnel, are identifïed in
the audit plan and the Audit Interview List.
4
Audit process and findings
4.1 Audit process
Within the scope of the audit, processes in the various departments of Rofil Medicaf International
(RMI) were audited in order to gain an understanding of the overall operation. Processes were
verified for conformity with the requirements of the above mentioned directives and standards
and descriptions in the quality system documentation. This verification was performed on a
sampling basis, by interviews, review of the corresponding documentation and actual
observation of processes.
Quaflty Management system/Document control
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The quallty manual contains descriptions of all processes. The interfaces of processes are also
identified and described. The modified Qualfty Manual was reviewed during the 3. Surveillance
Audit.
The company name Rofil Medical National N.V. (RMN) was implemented into the revised quality
manual. Therefore the quality manual covers Rofil Medical International (RMI) and Rofil Medical
Nederland B.V. (RMN).
The company implemented a document control system. The way of initiating and changing
documents and the approval process are described, Furthermore the storage locations are
included. The current versions of the quality manual and documents can be founcl in a manual
file. All associates have access to the current versions of the quality manual via the intranet
database, Retention periods of documents and records are defined.
In the prevous audit the auditor found within the quality assurance agreements that the
are obligated to follow the
European distributors
procedures defined by Rofil Medical International. These procedures are e.g. recali and
Updated
complaint handling including the requirements of
procedures and regulations are forwarded to the distributors.
.
.
.
Management!l mprovementlCustomer satisfaction
Management Reviews conducted annually are deemed suffident to ensure an effective
evaluation of the quality management system. Records of these reviews were maintained, The
Management Review for the period April 2005 until 28. December 2005 was reviewed by the
auditor. Evidence was supplied, that the quality system was evaluated and reviewed using
statistical methods (e.g. complaints, internal audits).
The next Management Review for a full period of one year (Jan.-Dec. 2006) will be performed at
the beginning of 2007.
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Regular quality meetings of the management team take place. The outcome of the quality
meetings like vendor evaluation and improvements are an additional input for the Management
Review.
An evaluation of the improvement is inciuded in the management review as well. Input criteria for
the evaluation are the evaluated processes, complaints, internal audits and customer feedback.
Furthermore, for each device of RMI an evaluation of potential improvements is discussed and
recorded.
Methods for the measurements of customer satisfaction are defined and implemerited, Post
market surveillance, a complaint analysis and additionally the regularly filled in “visitor reports”
for each visit at the customers are input criteria for the customer satisfaction and customer
requirement evaluation.
Measurements of the quality system were included and discussed and actions for improvement
were evaluated.
In addition, a separate management review report (dated on 15. August 2005) regarding
requirements of the Canadian MDR had been reviewed by the auditor in the previous audit. This
report is en attachment to the general Management Review Report to evaluate and covers the
Canaclian requirements additionally.
The Quality Plan 2006 including the training plan, planning of the internal and supplier audits
(e.g. PIP,
) was reviewed during the audit.
The documentation provided evidence of a continual ealuation of the management and
evaluation of the suitability and etfectiveness of the systern.
InternalAudit
Internal Audits are planned and performed ori a yearly basis to guarantee the maintenance and
a continuous improvement of the quality management system. The documentation of the intemal
audits inciude deviations and corrective actions, which was reviewed by the auditor. The intemal
audit planning and conducting included CMDCAS related requirements (Procedure “lnternal
Quality Audit” PRO 05.02.03; ‘Internal Audit Summary” RF 05.02.04). Deviations are
documented on a specific template for internal audits and corrective actions will be followed up
regularly.
Nevertheless, It is recommended, that all internal audits should be completed prior to the next
surveillance audit. Additionally the checklist RF 05.02.05A could be filled in more systematically
in an early stage
1f a non-conformity during the internal audit is detected or an improvement should be
implemented, a CAR (Corrective Action Request, RF 05.05.03) will be initiated. The CAR will be
followed up and recorded until It will be closed. Examples of handling CARs were reviewed
during the audit
CARs, which had been closed, were verifled for effectiveness during the next internal audit e.g.
the effectiveness of the correction for the CAR no 149 (labelling issue) was verified during the
internal audit 23. August 2006.
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All CARs are tracked in the CAR overview list including closing dates and verification statement
of effectiveness. Preventive actions are additionally documented on the CAR formsheet.
An audit plan for 2006 was available.
Documentation provides evidence of a continually evaluation of the management and estimatïon
of the suitability and effectiveness of the system.
Human Resources
Job descriptions are in place and the functions of the employees are divided into 6 groups eg.
for the associates of the warehouse group. The training plan for 2006 had been approved and
signed by Mr.
(vice president). RMI evaluated en individual evaluation program for
personal objectives. The evaluation is performed and recorded once a year (PRO 06.01.04).
Examples of training records for the new secretary Mrs.
performed by Mrs.
dated on 21 Sept. 2006 (Training Report RF 06.01.03) was reviewed by the
auditor. Training topics were general information about QMS and complaint handling.
Effectiveness of training was evaluated and documented in the training record.
The next training of the sales and marketing employees for injectable implants is planned for CW
44. Until now no training plan for 2007 was available.
Documentation demonstrated evidence of an evaluation of training needs and assessment of
training.
Supplier/Technical Documentation
Rofil Medical International has various Notified Bodies.
All relevant procedures concerning the Directive 93/42/EEC and CMDCAS requirements are
under the control of Rofil Medical International NV.; e.g. specification of design and product
requirements and performirig onsîte inspections. Rofil Medical International inspects their
suppliers on a regular base, The inspections are recorded and RMI additionally includes an
evaluation whether the requirements of the Directive 93/42/EEC, and CMDCAS are fulfilled.
The procedure for the evaluation of the suppliers are in pIece (Procedure “Supplier Selection and
Evaluation” PRO 06.03.07).
For the suppliers a qua!ity assurance contract is defining tasks and responsibilities of the parties
including assistance in complaint handling and regulatory aspects.
The competence of subcontractors are demonstrated by Notifled Body certifications. Therefore,
this is enough evidence for the qualification of the suppliers.
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Outsourced processes summary:
Activity
Subcentractor
Manufacturer
(OEM)
Breast lmplants
Poly Implant Protheses (PIP), La
Seyne sur Mer, France
1
Controlled by
TRPS:
EN ISO 13485:2003 (exp.
2008-09-29)
TRPS issued for RMI an
MDD 93J42/EEC
Annex 11.4 (expiry date 14.
March 2009; 10 60008171
breast
0001) for the
implants
Breast implants not sold in
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Supplier: Poly Implant Protheses (PIP)
The gel pre-filled mammary breast implants are supplied by Poly Implant Protheses (OEM
device). For Rofil Medical International this device was approved by the Notified Body TUV
Rheinland Product Safety.
The medical devices supplied from Poly Implant Protheses are not sold in Canada.
The technical documentation for the breast implants (GE mark 0197) was already reviewed for
compliance to the requirements of Annex II of Directive 93/42/EEG for the “Smooth, micro
textured and textured high cohesivity gel pre-filled breast implants” by TUV Rheinland Product
Safety. A TUV Rheinland Product Safety medical device directive 93/42/EEC, Annex 11.4
certificate dated 22. July 2004 (expiry date 14. March 2009) with the ID 60008171 0001 has
been issued (see additionally TUV Rheinland Product Safety report # 21112263 002).
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A PIP supplier audit was performed by RMI on 27. January 2006. Several aspects had been
audited e.g. but not limited to labelhng requirements, design, production and complaints. None
deviations ware established by RMI during the supplier audit.
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Purchasing, Inspection, Storage, Distribution, Traceabillty
Customer order and order processing were reviewed, which are in compliance with the
documented procedures.
Incoming
The procedure of ordering breast implants at PIP was described by Mr.
for an
inspection and release of purchased device for selling were demonstrated by Mr.
order at PIP, dated 15.05.06. The release report was filled in (RF 02.03.02F) and approved by
who is responsible for regulatory affairs and device release. After the approval the
Mrs.
device was released for sale.
To reduce the stock in the warehouse the order of new devices by the supplier is activated by a
customer order. Furthermore, if less devices are on stock a new device order is initiated, The
stock of devices can be tracked by the database “Exact Globe”.
In the warehouse the incoming inspection, release documentation, device storage, quarantine
storage, labelling, device goods shipments (FiFo-principle) and the traceability of batches were
reviewed.
)n a sampling
‘its are
breast in
temperature is recorded three times a day and
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the records are stored.
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On a sample base the customer order handling of breast implants for the customer M. (deb. No.
13057) was reviewed in detail.
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Products on-hold were stored separately in designated areas.
The traceability of shipped products is tracked within the RMI data base called “Exact Globe”.
For example the consignee of the breast implants IMGHCTXH-390 with Lot 15606.043 was
reviewed and could be verified by the data base.
Traceability is assured via the “Exact Globe” database and additionally via shipping records,
which are physically stored.
Daily back ups of the database are stored in a separate place.
Complaint Handling, Vigilance system
Complaints and vigilance cases are tracked in the data base “Complaint Handling and Analysis
Database”, developed by Rofil Medical International N.V.,
The process of complaint handling was audited as an example of a hydro-gel filled mammary
implant problem, which was reported on 4. July 2006. The problem was weight loss of the breast
implant (lot 02899-105). The handling of the patient-related but not critical incident (complaint#
60110, documented on complaint report form RF 05.03,02) was reviewed by the auditor
inciuding reporting and documentation of the correspondence with the physician and competent
authority. The complaint was closed on 4. August 2006. Nevertheless the patient-related incident
with a breast implant had not been reported to the Notifled.Body (see procedure PRO 05.03.07,
refer to deviation no. 4).
The commercialisation of this hydro-gel implant type had been stopped years ago.
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The procedure how to handle and document recalls was theoretically described by Mr.
05.03.).
Furthermore the procedure and handling of vigilance cases was described by Mrs.
compliance to the corresponding procedures.
1
in
The company provided evidence of thorough documentation and the corresponding procedures
ware followed (Complaint Handling PRO 05.03.01, Vigilance System PRO 05.03.07, Corrective
and Preventive Action PRO 05.05.02). Evidence was provided, that complaints were handled in
a timely manner.
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The post market surveiflance report dated 4. July 2006 was reviewed by the auditor, The post
market surveillance report evaluates e.g. device and/or patient related complaints, literature
evaluation, sales information about the medical devices with general information from the
customers for evaluation of the safety/functionality of the device and wishes of the customers,
Procedures for Corrective and Preventive actions are in place.
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4.2 Findings
During the audit, 4 deviations ware established. These deviations were documented in
4 deviation reports. They did not effect the effectiveness of the QM-system.
Specifïc deviation to the MDD Directive
The following deviation against the MDD directive was established (sea deviation report):
1/4: MDD 93/42/EEG
RMI changed the address, but e.g. on the labels, brochures the old address is still included.
Furthermore the Notified Body has not been informed about this change.
Specific deviations to EN 180 13485:2003, ISO 13485:2003 urider CMDCAS
The followin
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1
c deviation to EN ISO 13485:2003, EN ISO 9001 :2000
The following deviation against these regulations was established (see deviation report):
4/4: EN ISO 13485:2003; 8.5
The patient related incident (complaint no. 60110) with a breast implant has not been notified to
the Notified Body (sea procedure PRO 05.03.07)
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Post audit note:
In addition corrective actions were implemented for the Mammary lmplants (Smooth, micro
textured and textured high cohesMty ge! pre-filled breast implants) because of,the company
name change. The provided documents are in the review process.
5
Canciusion
Ron! Medical International NV. (respective RoflI Medical Nederland BV.) has furnished proof
that It maintains a quality management system which fulfils the above mentioned requirements.
The requirements of EN ISO 9001:2000, EN ISO 13485:2003 and ISO 13485:2003 under
CMDCAS were fulfihled.
The requirements of the Directive 931421EEC Annex 11.3 were fulfifled as well.
The qua!ïty management chapter (7.5.4) Control of customer supphied products was not
applicab!e.
Within the scope of the quality management system all applicable processes have been
described in sufficient detail in the quahity manual, procedures and instructions.
During the audit the auditor verified that processes ware performed in accordance with the
quality management system documentation.
The QM documentation is described in a short and suitable manner and is implemented by
personnel. Procedures and work instructions reflect actual processes and will be revised as
needed.
Management reviews are conducted at regular intervals ensure an effective evaluation of the
quahity management system.
Management documented its commitment to implement and maintain the quality system by
approval of the Quality Manual. The quahity pohicy and the defined quahity objectives ware
disseminated through all hevels of the organization. The company implemented and maintained
procedures and processes to achieve defined quahity objectives. Personnel on all levels of the
organization had the necessary awareness of the quahity management system.
The responsibility and authority of personnel who manage, perform and verify work that affects
the quality of the products ware defined.
Resources for maintaining the Quahity Management System ware sufficienthy provided by the
management.
nternal Audits ware planned and performed on a yearly base to guarantee the maintenance and
a continuous improvement of the quahity management system. The internal audit program
insured that findings during intemal audits were fohlowed up in a timeby manner.
Procedures describing responsibihities for identifying failures and non-conformities were
implemented. Resulting corrective and preventive actions are fohlowed up.
The post market surveillance procedures and the implementation of the resulting corrective and
preventive actions ware evaluated and found to be effective.
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During the audit 4 deviations were found, The deviations did not impact the overa effectiveness
of the QM-system. Corrective actions for the deviations established during the audit were
implemented and deemed to be acceptable.
The implementation of the corrective measures to the 4 deviations established during the last
audit were also evaluated and deemed to be acceptable,
6
Comment and remarks
The auditor point out the following observations and recommendations:
•
t is recommended to complete the internal audits prior to the next surveillance audit.
Additionally, the checklist RF 05,02.05A could be fiHed in more systematicaHy at an early
stage.
The key performance indicators could be evaluated more precisely,
The outcome of the regular post market surveillance evaluation including the risk assessment
of the devices could be documented more precisely e.g. within the Management Review.
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• Significant chariges e.g. to procedures, devices and further should be reported to TUV
Rheinland Product Safety / TUV Rheinland of North America. 1f RMI could not evaluate the
relevance of the changes, it is recommended to contact TÜV Rheinland Product Safety
GmbH / TUV Rheinland of North America in aduance for clarification.
Audit post notes:
• TÜV strongly recommends, that corrective actions to the deviations established during the
audit should be implemented in a timely manner and sent to the auditor for review within the
established due date in the future.
• Please take into account, that e.g. supplier contracts should be revised including the new
company name Rofil Medical Nederland B.V.. In addition the competent authority should be
notified.
TÜV Rheinland Product Safety GmbH requests to be notified in case of any significant
changes to the company’s quality management system or the qualification status of the
suppliers.
Audit report-GB.doc
QFI2REPT
Rev. 4; 2003-07-31
Rev. 6; August 2003
Pagel7ofl8
AuditReport
21 104600_008 (TRPS)
30592855_002 Version 3 (TRNA)
7
TÜV
r0v Rheinland
Berlin Brandenburg
Genera’ notes
TÜV Rheinland Product Safety GmbH requests to be notified in case of any significant changes
to the company’s quality management system (e. g. changes to procedures which concern the
development, the production or the end contro’) during the time of validity of the certificate.
Furthermore TUV Rheinland Product Safety GmbH requests to be notified in case of product
recails for medical or technical reasons as well as for any report on incidents or naar incidents as
defined in the current version of MEDDEV 2.1211 (Guidelines on a Medical Devices Vigilance
System).
TUV Rheinland of North America, mc. requests to be notified in casa of any significant changes
to the company’s quallty management system (e.g, changes to procedures which concern the
development, the production or the end control) during the time of validity of the certificate.
Furthermore TUV Rheinland of North Arnerica, mc. requests to be notifïed in case product
recalls for medical or technical reasons as well as for any report on incidents or naar incidents as
defined in the Canadian Medicat Devices Regulations.
The audit was performed by means of sampling objective evidence. Therefore, further deviations
not established during the audit may exist. The findings and conciusions of the auditors do not
release the company from its responsibility to ensure compliance with and constant observance
of the requirements of the applicable standards.
End of Report
Attachments:
Medical Device License Listing
Audit Interview List
Audit report-GB.doc
QFI2REPT
1
niet
aanwezig
Rev. 4; 2O0307-31
Rev. 6; August 2003
Page 18 of 18
Applicatlon for EC conformlty
asses3ment procedure
(productreIated evaliiaUon)
TUV
TÛv Rand Group
Appilcatlon for EC Conformity Assessment Procedure at the Notified Body for
medca devce of the TOV Rhelnland Product Safety GmbH
based on the Medical Devces Directive 931421EEC
0 AnnexH,section4
0
AnnexIII,section2
based on the Directive far Active Implantable Medica Devices 9013851E EO
0 Annex 2, section 4
/4
Manufacturer
(Name nd Mdress)
RofÏ Medica hternational NV.
/ /
Smedejstraat2_____
4814 D8 breda
the Netherlands
/ &/
/ FL /
/ 4hJ/
‘‘
EC-Authorized Representative;
(Name ar Address)
E
.•••
Appflcatlon confomfty assessment product-GB.doc
.......
..
.,.
FeV. 3; 2008-01-01
....
page
1 o12
Appilcatlon for EG conformlty
assessment procedure
(productreiated evaluatlon)
TÜV
TÜv Rhelnland Group
The appilcant deciares,
-
-
-
-
-
-
the design descrlption of the product Is attached to this appflcation;
that no appilcation has been lodged with any other notifled body for the same product(s)
described in the attachment(s) “Product description-GB.doc”;
to keep the design documentation Inciuding documents provided by the TÜV Rheinland
Product Safety GmbH for a period of the life-span of the medical device, but at least for
fnte years after the last product has been manufactured;
that all devices In scope must meet the essential requirements set out in Annex 1 of the
directive 93!42/EEC resp. 901385!EEC;
to Inform the TOV Rheinland Product Safety GmbH of any changes to the approved
design or the approved produci
to notify the competent authoritles and the certiflcetion body of the TOV Rhelntand
Product Safety GmbH of the followlng lncidents Immediately ori leaming of them:
i) any matfunction or deterioration in the characteristics and/or performance of a device,
as well as ariy inadequacy in the Instructions far use which might lead to or might have
led to the death of a patient or user or to a sericus deterioration In his state of health;
Ii) any technical or medical reason connected with the characteiistics or performance of a
device leading for the reasons referred to In paragraph 1) to systematic recali of
devices of the same type by the manufacturer.
Manufacturers whlch do not have a registered place of business In a Member State,
additlonaily deciare,
-
-
-
to designate a authorized representative who Is established In the Community;
to iriform the TÜV Rheiniand Product Safety GmbH In case of changing the authorized
representative;
that the representative must make the design docunientatlonltechnlcai documentatian,
Including the declaration of conformity, avallable for inspection purposes for a periad of
the life-span of the medical device, but at least for live years after the last pcaduct has
been mariufactured.
ÇçecIg,
Place, bate
-/O3/:-
np
Attachment(-a): Product Descrip&n(-s)
ApIcaUcin ccnformfty assessment product-GBdoc
Rev. 3, 2006-01-01
page 20f 2
2.
lOjid2,e
EG Design-examination report
for the product
IMGHC
(RMI silicone breast implant)
Design Dossier ID
M-Implants
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda the Netherlands
Design dossier report-GB.doc
Rev. 1; 2002-08-05
page 1 of 9
EG Design-examination report
MDDIAIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
FOVRheInIand Product Safety GmbH
TÜV
Unehmene
TÜV RheinlandlBerlinBrandenburg
Order No.: 1006808
ReportNo.: 21112263_002
Table of contents
A. General
3
B. Product categorization and choice of procedure
4
C. Examination of the design of the product
1. Design specification
2, Techniques to control the design mci. mechanicai/physical testing
3. Essential requirements
4. Connection to other devices
5. Combination wfth medicinal products
6. Material of animal origin
7. Ciinical data/Performance data
8. Stability
9. Label and Instructions for Use
10. Biocompatibility
11. Sterilization
12. Evaluation of the risk analysis
4
5
5
5
5
5
6
6
6
6
7
7
7
D. ManufacturingoftheProduct
8
E. Batch Release (IVD)
8
F. Summary
8
G. Important Note
8
Design dossier report-GB.doc
Rev.1; 2002-08--05
page 2 of 9
EC Design-examination report
MDDIAIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
TÜVRheinIand Product Safety GmbH
Order No.: 1006808
A.
TÜV
untemehmensgwppe
TOV Rheiniand!Bertin-Brandenburg
ReportNo.:21112263_002
General
Product name:
M-l mplants
Type(s)IModeI(s):
Textured: IMGHC TX
MicroTextured: IMGHC
—
—
Smooth: IMGHC
MX
—
LS
Profiles: Hemipheric profile: Standard (S), High (H), Ultra high
(UH), Other profîles: Reconstruction (R), Asymmetrical (AR)
or (AL)
Volume: 85 to 705 cc (depending on profile and surface of shell)
Product group:
Mammary lmplants
Legal
manufacturer:
Rofil Medical International N.V.
Heusing 16
4817 ZB Breda the Netherlands
OEM-Product:
x
Manufactu ring
facility:
Poly lmplants Protheses (PIP)
yes
Eno
337, Avenue de Bruxelles
83514 La Seyne S!M Cedex
Sterilization facility: Information available in the file of:
Poly lmplants Protheses (PIP)
337, Avenue de Bruxelles
83514 La Seyne SIM Cedex
Design Dossier file: M-lmplants
Date:
9.04.2004
Revision:
9.04.2004
DepartmentlGroup: Regulatory Affairs
Dr.
Author:
J’- ?
Date
Name Reviewer 1
Date
Name Reviewer 2
ei—
Design dossier report-GB.doc
Rev.1; 2002-08-05
page 3 of 9
EC Design-examination report
MDDIAIMD: Annex II, Section 43
IVDD: Annex IV, Section 4.3; Annex III, Section 6
Order No.: 1006808
B.
TÜV
Rhelnland Product Safety GmbH
TÜV
Untemehmen5gruppe
TIJV Rheinland!Bertln-Brandenburg
ReportNo.: 21112263_002
Product categorization and choice of procedure
The “Implant Mammaire pre-rempli de el a Haute Cohesivite» (IMGHC) devices
are silicone pre-filled breast implants used in plastic surgery for breast
augmentation or breast reconstruction.
All breast implants are classified as class III medical devices in accordance with
Directive 2003/12/EC of 3. February 2003, Article 1 “By way of derogation from the
rules set out in Annex IX to Directive 93/42/EEG, breast implants shali be
reclassified as medical devices falling within class III”.
C.
Examination of the design of the product
The assessment was performed by means of an examination of the documents
which are contained in a design dossier named M-Implants (dated 9.04.2004).
Each individual revision status of documents is marked on the documents inciuded
into the DD.
Rofil Medical International N.V, Netherlands as private label manufacturer does not
manufacture the breast implants.
The silicone filled breast implants are manufactured by Poly lmplants Protheses
(PIP), France, and were approved by TÜV Rheinland Product Safety GmbH after
review of the corresponding provided documents. A TÜV Rheinland Product Safety
GmbH ID 60007598 0001 certificate according Annex II, section 4 of Directive
93/42/EEC has been issued (see additionally TRPS report 21111398 004).
Full technical documentation is on file at TÜV Rheinland Product Safety of the
OEM- manufacturer Poly lmplants Protheses (PIP) with the design dossier # SQ
1/02 DOT 202.
Art OEM-contract between the private label manufacturer Rofil Medical
International N.V, Netherlands with the OEM manufacturer Poly lmplants
Protheses (PIP), France defines tasks and responsibilities of the parties.
The OEM-contract is inciuded into the DD and corresponds to the Answers and
Resolutions of the EK-Med 3.5 A5.
The structure of the provided documents corresponds to Annex II, section 4 of
Directive 93/42/EEC as it includes essential documents for an OEM-device as a
general description of the device, the applicable standards, documentation to the
essential requirements, labeling, instruction for use, risk estimation and the
responsibilities of the OEM manufacturer PIP and private label manufacturer Rofil.
A declaration of conformity according to 93/42/EEC for the above mentioned
products is available.
Design dossier report-GB.doc
Rev.1; 2002-08-05
page 4 of 9
EC Design-examination report
MDDIAIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
TÜVRhainIand ProductSafetyGmbH
TÜV
Untemehmenppe
TOV RheinIanWBertIn-Brndenburg
Order No.: 1006808
1.
ReportNo.: 21112263_002
Design specification
The design dossier contains a description of the product inciuding all
relevant information about the used materials.
The following Silicone filled breast implants are described:
“!mplant Mammaire pre-rempli de Gel a Haute Cohesivite” (IMGHC)
The full information can be found in the design dossier provided by the
OEM manufacturer PIP for the IMGHC with the dossier name SQIIO2 DOT
202, Index K on file at TÜV Rheinland Product Safety.
Accessories:
Accessories are not described in the design dossier.
2.
Techniques to control the design mci. mechanicallphysical testing
The techniques used to control the design is located at Poly lmplants
Protheses (PIP), France (see additionally TRPS report 21111398 004).
3.
Essential requirements
The essential requirements are established in a questionnaire of the
design dossier. It is organized in such a way, that for each applicable
Essential Requirement a reference to the individual standard has been
provided. Poly Implants Protheses (PIP) as the OEM-manufacturer fulfills
the essential requirements (see additionally TRPS report 21111398 004)
for the device in question. Additionally the responsibilities of the private
label manufacturer according labeling, instruction for use (clause 13 of
Annex 1 of Directive 93/42/EEC) are addressed.
The provided documentation was found to be in compliance with the
essential requirements as specified in Annex 1 of Directive 93/42/EEG.
4.
Connection to other deviceslinstruments
Connection to other devices/instruments is not applicable
5.
Combination with medicinal products
Directive 93/42/EEG, Annex 1, section 7.4 is not appilcable.
Design dossier report-GB.doc
Rev. 1; 2002-08-05
page5of9
EC Design-examination report
MDD1AIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
Tüv Rh&nland Product Safety GmbH
TÜV
Untemmenuppe
iOv RheinTandIBerfn-Brandenburg
Order No.: 1006808
6.
ReportNo.:21112263_002
Material of animal origin
Directive 93142/EEC, Annex t, section 8.2 is not applicable.
7.
Clinical datalPerformance data
Poly lmplants Protheses (PIP) as the OEM-manufacturer of the devices
provided a clinical evaluation (see additionally TRPS report 21111398
004).
A clinical evaluation was performed to show compliance with the essential
requirements of the Directive 93/42/EEC in respect of achieving the
performance intended by the manufacturer and of determining any
undesirable side-effects, under normal conditions of use, and assess
whether they constitute risks when weighed against the intended
performance of the device. The clinical evaluation is included into the Poly
lmplants Protheses (PIP) design dossier SQ 1/02 DOT 202 (on file at TUV
Rheinland).
The basic technology is not new. Silicone pre-filled breast implants have
been in use since 1962. The procedure, the indications and contra
indications are known among experts.
8.
Stability
Theshelf life is3years.
Poly lmplants Protheses (PIP) as the OEM-manufacturer provided stability
studies covering a 3 year shelf life of the devices (see additionally TRPS
report 21111398004).
9.
Label and Instructions for Use
Labelling for the private label man ufacturer Rofil Medical International N.V,
Netherlands is described in the design dossier.
Poly lmplants Protheses (PIP) as the OEM-manufacturer labels the
devices for Rofil Medical International.
Design Changes in the labeling and the instruction for use need to be
approved by Rofil Medical International, which has been agreed in the
provided OEM-contract.
Examples for the labels (Rev. 24.05.03) for the high cohesivity gel pre-fihled
breast implants can be found in the DD.
Design dossier report-GB.doc
Rev. 1; 2002-08-05
page 6 of 9
EG Design-examination report
MDDIAIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
4t.
TüVRheinIand Product SaPety GmbH
TÜV
Untemehmensgme
TOv RhelnianWBartin-Brandenburg
Order No.: 1006808
ReportNo.: 21112263_002
The instructions for use (Rev. 20.02.01) corresponds with the information
for use of the OEM-manufacturer Poly lmplants Protheses.
Labels and the instruction for use are in compliance with Directive
93/42/EEC, Annex 1 and the harmonized standards EN 980 and EN 1041.
10.
Biocompatibility
The biocompatibility tests are based on the selection of tests listed in
EN 10993-1 which have been provided by the OEM-manufacturer Poly
lmplants Protheses (PIP) (see additionally TRPS report 21111398 004).
11.
Sterilization
The sterility assurance level (SAL) of 106 is obtained using Ethylene Oxide
Slerilization (see additionally TRPS report 21111398 004). There are no
changes of e.g. packaging, therefore the sterilization validation is covered
by the provided documents of the OEM-manufacturer.
12.
Evaluation of the risk analysis
The Risk Analysis with the title “Risk Management: M-lmplants” dated
m April 2004 was written by T. Lopez and 1. Korswagen in accordance
24
with the harmonized standard EN ISO 14971 and can be found in the DD,
Additionally the OEM-manufacturer Poly lmplants Protheses (PIP) (see
additionally TRPS report 21111398 004) identified risks related to the
device.
Qualitative and quantitative characteristics related to the devices have been
identified.
Based on this the possible hazards are identified for normal and single
fault conditions, the possible causes for such hazards are evaluated and
the effects determined. Risks have been estimated for each hazard.
The remaining risks for the devices are deemed to be acceptable.
Design dossier report-GBdoc
Rev.1; 2002-08-05
page 7of 9
EG Design-examination report
MDDIAIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
Order No.: 1006808
D.
rüv Rheinland Product Safoty GmbH
TÜV
intemehmensgruppe
rtV RheInIandiBeiin-Brandanburg
Report No.: 21112263 002
Manufacturing of the Product
The manufacturing process can be found in the design dossier SQ 1/02 DOT 202
(on file at TUV Rheinland) of the OEM-manufacturer Poly lmplants Protheses
(PIP).
The manufacturing facility PIP is certified according to the MDD Annex 11.3. The
related certificate is issued by TOV Rheinland Product Safety GmbH.
A TÜV Rheinland Product Safety GmbH HD 60006072 0001 certificate according
Annex II, section 3 of Directive 931421EEC including the scope for M- implants has
been issued for the private label manufacturer RMI.
E.
Batch Release (IVD)
Not applicable
F.
Summary
Previously breast implants were classified as class lib medical devices in
accordance to MDD Annex IX, rule 8. Nowadays all breast implants were re
classified as class III medical devices in accordance with Directive 2003/12/EC of
3. February 2003, Article 1.
The silicone fihled breast implants are manufactured by the OEM-Manufacturer
Poly Implants Protheses (PIP), France. A TÜV Rheinland Product Safety GmbH
lD 60007598 0001 certificate according Annex II, section 4 of Directive 93/42/EEC
has been issued (see additionallyTRPS report 21111398 004).
Silicone pre—filled mammary implants has been utilized for several years. The
procedures and the techniques used, the indications and contra-iridications for
their application are known among experts.
The intended use has been evaluated during review of the DD of the OEM
Manufacturer Poly Implants Protheses.
The documents submitted provide evidence that the products in question meet all
requirements of Annex 1 and Annex II section 4 of the Directive 93/42/EEC and are
sufficient for a positive technical evaluation.
Design dossier report-GB.doc
Rev.1; 2002-08-05
page 80f 9
EC Design-examination report
4
t
.
MDD!AIMD: Annex II, Section 4.3
IVDD: Annex IV, Section 4.3; Annex III, Section 6
Tav Rhelnland Product Safoty GmbH
TÜV
untem&,mensg,e
TaV Rheinlandlaeriifl-&andenburg
Order No.: 1006808
G.
ReportNo.:21112263_002
Important Note
Modifications to the Product may only display the CE mark after testing and
approval by the notified body, TÜV Rheinland Product Safety GmbH.
It is requested that the certification body should be informed in cases of incidents,
near incidents, product recalis or other requests to products in the scope of the
approval of the notified body.
END OF REPORT
Design dossier report-GB.doc
Rev. 1; 2002-08-05
page 9 of 9
-
Zweitschrift
(Copy)
-
4
TÜV R hein la d
APPROVAL
EC Directive 931421EEC Annex ii, Article 3
Full Quality Assurance System
Medical Devices
Registration No.:
HD 60022415 0001
Report No.:
21136725 002
Manutacturer:
Rofil Medical
Heusing
Scope:
Design/Development and Manufacture of non-active
implantable Medical Devices
Products:
see attachment
Replaces Approval,
Date of Expiry:
B.V
Registration No.: lID 60017888 0001
28.09.2013
The Notified Body hereby authorizes the quality management system established and applled by the
company mentioned above. The requirements of Annex II, Article 3 of the directive have been met.
This approval is subject to periodic surveillance, defined by Annex II, Article 5 of the aforementioned
EC Directive, and can be used by the company wlth the manufacturer’s declaration of conformity.
Notified Body
Cotogne,
29.09.2008
TÜV Rheinland Product Safety GmbH
-
Am Grauen Steiri
-
D-51 105 Köln
Accredited by ZentralsteUe der Lnder fOr Sicherheitstechnik (ZLS) and
Zentralstelle der L.nder fOr Gesundheitsschutz bel Arzneimittetn und Medizinprodukten (ZLG).
Notified under No.
C€
01 97
to the EC Commission.
The CE marking may be used It all relevant and effective EC Directives are complied with.
Inh.=3057500 / Deb.=3057500 / Fert.=3057500
(
r.
t
Zweitschrift
(Copy)
-
TlJVRheinIand
TÜV Rheinland
Product Safety GmbH
Doc.
1/1, Rev. 0
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
HD 60022415 0001
21136725 002
Manufacturer:
Rofil Me5j4.î
Keusjp’ 1 6
Scope:
Products:
d B.V.
Smooth, micro-textured and textured high cohesivity
gel pre-filled breast iznplants
Certification Body
Cologne, 29.08.2008
-
Zweitschrift (Copy)
-
TUVRheinland
EC Design Examination Certificate
EC Directive 93142 IEEC Annex II, Articte 4
Medical Devices
Registration No.:
ID 60017891 0001
Report NoS:
21112263 004
Manufacturer:
Manufacturing Facility:
Heusing 16
4817 ZB
Neth
Rofil Medical Nederland B.V.
Heus ing 16
4817 ZB Breda
Netherlands
Product:
Medical Device
Mammary lmplants
Identification:
srnooth, micro-textured and textured high cohesivity
gel pre-filled breast implante
Producte:
Inh.
=
3057500
/
see attachment
.ttion No.:
30
Deb.
ID 60008171 0001
The EG design examination certificate refers to the above mentioned product. It certifies that
the design documentation of the product complies with Annex II, Article 4 of the directïve.
The manufacturer is subject to EG surveillance in accordance with Annex II, Article 5 of
the directive. The manufacturer is entitled to use this certificate with the manufacturer’s
declaration of conformity,
Date of Expiry
14.03.2009
Notified Body
Cologne. 29.10.2007
TÜV Rheinland Product Safety GmbH
-
Am Grauen Stem
-
D-51 105 KöIn
Accredited by Zentralstelle der Lnder für Sicherheitstechnik (ZIS) and
Zentralstelle der Lander für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG).
Notified under No.
0197
to the EG Commission.
The CE marking may be used if all relevant and effective EG Directives are complied with.
CE
Zweîtschrft t copy
TUVRheinand
Doc. 1/12, Rev. 0
TÜV Rheintand
Product Safety GmbH
Am Grauen Stem, D-51105 Köln
Attachment to
Registration No.:
Report NoU:
Manufacturer
ID 60017891 0001
21112263 004
Rofil Medical
Heusïng 1.-’
481 7r3
Nethkr
‘
Scope:
M am m\iÇants
IMGHCLS-S Srnooth sur-face standard profile high cohesivity gel pre-fifled breast implant
CODE
________
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
ItvTGHC
IMGHC
JMGHC
IMGHC
MGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
-
-
1
SURFACE
PROFILE
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STArIDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
SMDOTH
FTANDARD
SMOOTH
STANDARD
SMOOTH
STANDARD
Cologne, 29.10.2007
[
VOLUME
DIAMETER
(cc)
85
105
125
145
165
185
205
225
(mm)
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
265
285
305
325
345
365
415
455
505
555
605
655
705
—
PROJECTION
(mm)
18
20
21
23
26
27
28
29
30
31
32
33
34
35
34
35
36
37
38
39
40
41
Zweftschrift / copy
-
TUVRheinarid
Dcc. 2/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 Köfn
Attachment to
Registration No.:
ReportNo:
ID 60017891 0001
21112263 004
M anufactu rer
v
Rofil Medica! Ned
Heusing 16
4817ZB
Scope:
IMGHC-LS-H : Smooth surface High prol9le High cohesivity gel pre-tilled breast implants
-
-
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
JMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
I1GHC
IMGHC
[
,t,RrA
i..ODt
-
—
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMQOTH
SMOOTH
SMOOTH
SMOOTH
SMODTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMOOTH
SMQOTH
SM0OTH
SMOOTH
Cologne, 2910.2007
—
1
PROFILc
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
1
VOLUME
DIAMETER
PROJECfI 1
(cc)
(mm)
(mm)
90
130
150
110
190
210
230
250
270
290
310
330
350
390
430
470
510
570
620
680
80
84
90
94
98
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
29
32
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
-
Zweitschrift / copy
T:
-
TÜVRheinand
Doc. 3/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 Köln
Attachment to
Registration No.:
ReportNo.:
ID 60017891 0001
21112263 004
Manufacturer
Rofil Medical Nederlan
Keusing 16
4817 ZB Bred
Netherla
Scope:
Mamma
V
IMGHC-LS-UH: Smooth surface UltraHigh profile High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
IMGHC
IMGHC
IMGH
IMGHC
IMGHC
iMGHC
IMGHC
IMGHC
SMOOT1T
SMOOTH
SMOOTH
SMOOTH
SMQOTH
SMOOTH
SMOOTH
SMOOTH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HiGH
ULTRA-HiGH
ULTRA-HIGH
ULTRA-HIGH
F
VCijjIF
(cc)
245
265
295
335
365
405
425
495
DIAMFTFR
-
(mm)
101
104
107
112
116
120
l23
128
PPfljFCTtflN
(mm)
50
51
53
54
56
58
60
62
Cologne, 29.10.2007
ItC3 1? L)
-
Zweitschrift 1 copy
TÜVRheIn la d
Doc. 4/12, Rev. 0
TÜV Rheinlarid
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registration No.:
Report No.:
ID 60017891 0001
21112263 004
Manufacturer
Rofil Medic
Scope:
Mammary Implants
.v.
MGHC-MX-S : Micro-Textured surface Standard profile High cohesivity gel pre-fitled breast implants
CODE
MGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MGHC
IMGHC
IMGHC
MGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGI-IC
JMGHC
IMGHC
SURFACE
PROFILE
MICROTEXTURED
STANDARD
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
MICROTEXTURED TANDARD
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTIJRED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICRQTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
MICROTEXTURED f_STANDARD
MICROTEXTURED] STANDARD
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
STANDARD
MICROTEXTURED
Cologne, 29.10.2007
—
VOLUME
EMAMEtER
(cc)
85
105
125
145
165
185
205
225
245
265
285
305
325
345
365
415
455
505
555
605
655
705
(mm)
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
—
PROJECÏÖ
(mm)
18
20
21
23
26
27
28
29
30
31
32
33
1
[
35
34
35
36
37
38
39
40
41
Zweitschrift / copy
-
TUVRheinland
Doc. 5/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Graueri Stem, D-51105 Kötri
Attachment to
Registration No.:
Report No.:
ID 60017891 0001
21112263 004
Manufacturer
Rofil Medical Nederlan
Heusing 16
4817 ZB Bred
Netherlan
Scope:
Mammary 1
IMGHC-MX-H : Micro-Textured surface High profile High cohesivily gel pre-filled breast impiants
CODE
SURFACE
PROFILE
VOLUME (cc)
DIAMETER
(mm)
PROJECTION
(mm)
IMGHC
IMGHC
IMGHC
MICROTEXTURED
MICROTEXTURED
HIGH
HIGH
HIGH
90
130
150
80
84
90
29
32
34
IMGHC
MICROTEXTURED
HIGH
170
MICROTEXTURED
MICROTEXTURED
MICRQTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTFXTURED
MICROTEXTURED
M1CROTEXTURED
MICROTEXTIJRED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
190
21
230
250
270
290
310
330
350
390
430
470
510
570
620
680
94
98
35
36
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
MICROTEXTURED
IMGHC
IMGHC
IMGHE
IMGHC
IMGHC
MGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC__-
-
-
-
[
1
—
Cologne, 2910.2007
IC
CU
-
Zweitschrift / copy
-
TUVRheinland
Doc. 6/12, Rev. 0
TÜV Rheinlarid
Product Safety GmbH
Am Grauen Stem, D-51105 Köin
Attachment to
Registration No.:
Report NoU:
ID 60017891 0001
21112263004
Manufacturer
Rofil Medica
Scope:
Mammary Implants
IMGHC-MX-UH : Mcro-Textured surface Ultra-High profUe High cohesivity gel pre-filled breast implants
CODE
SURFACE
PROFILE
VOLUME
(cc)
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
MICROTEXTURED
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
245
265
295
335
365
405
425
495
IMGf
IMGHC
IMGHC
Cologne, 29.10.2007
1
DIAMETER
(mm)
101
104
107
112
116
—
120
123
128
PROJECTION1
(mm)
50
51
53
54
56
56
60
62
.1
-
Zweitschrift 1 copy
-
TUVRhejnland
Doc. 7/12, Rev. 0
TÜV Rheintand
Product Safety GmbH
Am Grauen Stem, D-51105 Köfn
Attachment to
Registratîön No.:
Report No.:
ID 60017891 0001
21112263 004
Manufacturer
B.V.
Scope:
MGHC-TX-S: Tectured surface Starrdard profile High cohesivity gel pre4llled breast implants
CODE
SURFACE
VOLUME
PROFILE
(cc)
________
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
MGHC
IMGHC
JKtGHC
MGHC
IMCHC
IMGHC
IMGHC
IMGHC
MGHC
IMGHC
IMGHC
1MGHC
IMGHC
1MGHC
IMGHC
IMGHC
j__TEXTURED
—
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
Colo9ne, 29.10.2007
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
85
105
125
145
165
185
205
225
245
265
285
305
325
345
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANDARD
STANbARD
STANDARD
STANDARD
STANDARD
1
j
—
415
455
505
555
605
655
705
1
DIAMETER
(rem)
87
92
97
102
106
108
110
114
117
124
126
128
130
132
136
141
145
150
156
160
166
172
PROJECTION
(mm)
18
20
21
23
26
27
28
29
30
31
32
33
34
35
34
35
36
37
38
39
40
41
-
Zweitschrîft/copy
-
TÜVRheinland
Doc. 8/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachmerit to
Registration No.:
Report No.:
Manufacturer
ID 60017891 0001
21112263 004
v.
Rofit Medîcal
Heusing
4817
N
Scope:
IMGFJC-TXH : Textured surface High profile High cohesivity gel pre-filled breast implants
[
CODE
SURFACE
PROFILE
VOLUME (cc)
DIAMETER
(mm)
PROJECTION
(mm)
IMGHC
IMGHC
IMGHC
IMGHC
FMGHC
IMGHC
1MGHC
IMGHC
IMGHC
IMGHC
IMGF-IC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
i1GHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
HIGH
90
130
150
170
190
210
230
250
270
290
310
330
350
390
430
470
510
570
620
680
80
84
90
94
98
102
105
109
112
115
118
121
126
128
135
142
146
151
157
160
29
32
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
—
[
j
1
—
Cologne, 29.10.2007
?oS2P ¶2
-
Zweitschrift / copy
-
TUVRheinIand
Doc. 9/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, 0-51105 KöIn
Attachment to
Registration No.:
Report No.:
10 60017891 0001
21112263 004
Man ufactu rer
Rofil Medical
Heusing 16
4817ZB
Scope:
Mammary
IMGHC-TX-UH
CODE
[
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
IMGHC
ints
Textured surface ultra-High profile High cohesivity g& pre-filled breast imptants
1
SURFACE
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
Cologne, 29102007
]
PROFILE
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
ULTRA-HIGH
VOLUME
(cc)
245
265
295
335
365
405
425
495
1
DIAMETER
(mm)
101
104
107
112
116
120
123
128
1
PROJECTION
(mm)
50
51
53
54
56
58
60
62
-
Zweitschrift / copy
-
TUVRheinIand
Doc. 10112, Rev. 0
TÜV Rheinlarid
Product Safety GmbH
Am Grauen Stem, D-51105 KöIn
Attachment to
Registratlon No.:
Report No.:
Manufactu rer
ID 60017891 0001
21112263 004
Rofil Medical
Heusing 1
Scope:
B.V.
rnts
IMGHC-TX-R: Textured surface Reconstruction protile High cohesMty gel pre-filled breast implants
CODE
SURFACE
PROFILE
ijöLÜME
(cc)
WIDTH
(mm)
HEICHT
(mm)
PROJECTION
MAX! (mm)
IMGHC
IMGHC
IMGHC
IMGHC
!MGHC
!MGHC
IMGHC
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
TEXTURED
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
RECONSTRUCTION
180
220
260
330
420
500
600
111
113
120
127
132
143
154
96
98
98
111
118
124
137
39
41
44
48
53
57
60
Coiogne 29.10.2007
-
Zweïtschrft / copy
-
TUVRheinland
Doc. 11/12, Rev. 0
TÜV Rheinlar,d
Product Safety GmbH
Am Grauen Steîn, D-51105 KöIn
Attachment to
Registratiori No.:
Report No.:
D 60017891 0001
21112263 004
Manufacturer
Rofil Medical
Netherlands
Mamrnary Implants
Scope:
IMGHC-TX-AL : Textured surface Asymmetrical profile High cohesivity gel pre-fflled breast implants
CODE SIJRFACE
PROFILE
MGHC TEXTURED ASYMMETRICAL
MGHC TEXTURED ASYMMETRICAL
üWCTEXTUREDASYMMETRICAL
iïïi TEXTURPD ASYMMETRICAL
üi[c TEXTURED ASYMMETRICAL
iö TEXTURED ASYMMETRICAL
IKij:iTEXTuREDASYMMETRICAL
ii:i? TEXTURED ASYMMETRICAL
iKïië TEXTURED ASYMMETR1CAL
iib TEXTURED ASYMMETRICAL
CoIogne 29.10.2007
VOLUME
200
230
245
260
280
300
330
370
400
450
—
Left side
WIDTH(mm) HEIGHT(mm) PROJECTION (mm)
109
114
119
125
130
135
138
143
148
153
86
89
93
98
102
107
110
115
119
124
36
39
42
44
46
48
50
52
54
56
-
Zweitschrift / copy
-
TUVRheinland
Dcc. 12/12, Rev. 0
TÜV Rheinland
Product Safety GmbH
Am Grauen Stem, D-51105 Köln
Attachment to
Registration No.:
Report No.:
ID 60017891 0001
21112263 004
Manufacturer
Rofil Medicat Neder
Heusing 16
48l7ZBBred
Netherland
Scope:
Mamm
IMGHC-TX-AR: Textured surface Asymmetric
d B.V.
rY
t*a
ofile High cohesivity gel pre-filled breast implants
—
Right
side
I,II
CODE SURFACE
WIDTH(mm) HEIGHT(mm) PROJECTION (mm>
PROFILE
Iöi:jC TEXTURED ASYMMETR1CAL
üF TEXTURED ASYMMETRICAL
îFïJTExTURED ASYMMETRICAL
Kb’TEXTURED ASYMMETRICAL
iÏ:ï TEXTURED ASYMMETR1CAL
TEXTURED ASYMMETR1CAL
i’I1ö TEXTURED ASYMMETRICAL
IMGHC TEXTURED ASYMMETRLCAL
IMGHC TEXTUREDASYMMETRICAL
[LLC TEXTURED ASYMMETRICAL
200
230
245
260
280
300
330
370
400
450
109
114
119
125
130
135
138
143
148
153
86
89
93
98
102
107
110
115
119
124
36
39
42
44
46
48
50
52
54
56
Cologne, 29.10.2007
-_____
25. AUG. 2004 15:24
ROFIL MEDICAL INT BV 31765315660
NO. 4463
P. 2
-1
Rofil Mediçal International t&V.
ROFIL.
8.
4817 ZB Breda The Nerlnd
heU5fl9 16
T +81 (0)76 5315670 ‘. F 31 (0)76 5316660
t www.rofil.com
E rmlrofiI.com
Document; OEM Contract
Suppiement to Distributor contract
Rofil Medical International N.V. and Poly Jmplants Prostheses France
Date: 3 August 2004
OEM CONTRACT
1
2
3
4
5
6
7
8
9
Scoe: This agreement between Rofil Medical International NN. (RMI N.V.) in The
Netherlands and Poly Implant Prostheses (PIP) in France restricts itself to the products
M-Implants distributed woridwide for the cosmetic and aesthetic rnedicine market.
Periode This agreement is valid as long as the distribufion contract between Pl? and
RMI or until changes are required by one of the partJes and agreed by the other, the
Notified Body or the Competent Authorities.
Søecifications The M-Implants are high cohesive silicone gel and saline filled
mammary implants in a silicone elastomer shell with a smooth micro or normal
textured surfaced in the profiles: standard, high, ultra-high, reconstruction or
asyrnrnetric in several volumes, cliameters and projections. The products are produced
to the level of “ready-to-use” by Pl?. The products are released by Pl? to RMI NV.
RMI NV releases the product to the market. Pl? suppiles the product to RMJ N.V,
accompanied by the Pl? release documents.
Documentation: The product DMR and DDR are kept at Pl? as well as the Design
File, Pl? shail make the DHR available to RMI NV at its request. RMI NV. as “the
manufacturer” of M-Implants is responsible for the conformity of the product with
MDD93142/EEC of June 14, 1993. The M-Implants CE Mascer File is the
responsibility of RMI NV. Pl? shail hand over the documents requested by RMI NV
in order to cornpile the M-Implants CE Master File and the registrations of the product
in coirntries outside of Europe.
Tmceabilitv; The product traceability from raw materials to fins] product release is
the responsibility of Pl?. RMN NV is responsible for the product traceabillty from
final product release at Pl? to the customer,
Desian: Pl? is the design owner of the M-Tmplants.
DesIgn Chanaes: Pl? may carry out product design changes without the consent of
RMi NV. This excludes the change of M4mplants labels and instructions for use.
Changes of the labels and of the instructions for use regarding the M-implanta must
be subroitted to Rivil NV for approval. Only after the approval of RMI NV may the
changes be implernented. RMI NV may propose to Pl? design changes of the product
which will be carried Out upon Pl? approval.
Notifled Body / Competent Authority; The Notified Body responsible for the CE
marking of the M4mplants shail be allowed, at its request, to eamine the necessary
technical documentation. The same is applicable to any Competent Authority.
YiJlance Vigilance reporting and subsequent actions are the responsibility of R.M1
NV. Pl? is responsible for performing the necessary technical investlgation as a result
of a vigilance case and for reporting its findings to RMI in a written manner.
1
THE
BEAUTY
PHILOSOPI4Y
25. AUG. 2004 15:24
ROFIL MEDICAL INT BV 31765315660
NO. 4463
P. 3
10 SuppilerAudit: RMI NV shail be allowed to audit PJ.P prernises once per year or
more ifjustified. The Notified Body responsible for the CE marking of the M
Implants shail be aUowed to audit Pl? when required
11 Certificatlon status: PIP is requested to inform RMI NV, in wnting of any change in
its eertification status: Quality system certification loss, gain or change or withdrawal
the “CE Conformity Certificate”.
12 Complainta: Complaint handling is the responsibility of RMI NV,
13 Product NonconformiUes PIP shail immediately inform RMI NV. of any batch
related manufaeturing non-conformities of its knowledge and start the recail of these
batches. In case of product recails duc to manufacturing and/or testing non
conformities which affect the petformance and/or the safety of the product, it is the
resporisibility of Pl? top1 the product independently of the product recail being
started by RMI N.V. or by PIP.
14 Document Languae. All documents (production, sterilization and testing
procedures, biocompatibility and clinical reports, release documents) shail be written
in the English language to make the assessment of the documents by RMI N.V.
possibje 1 easier and to facilitate the registration of the products in countries outside
the EU.
This contract shali be signed by both companies management representatives as such
person are legal responsible for upholding the product status.
Rofil Meclical International N.V,
Regulatoy Affairs Manager
3/g/o4
Date:
ROFIL.
1
Rofil MdtcaI lntemaJonaI N.V
Heusing 16 4817 ZB breda The NethrIahds
f +31 (0)76 5315660
T +31 (0)16 5315670
E ,mGrorll.Com w&w.TotILcom
Date:
POLY IMPLNTs
337e Az de PROtHE$Es
Sru*ete
941098
T4L04
y
4
XG4841O7a
2
THE
BEAUTY
PKILOSOPHY