10 March 2016
Dear Members of the European Political Institutions,
RE. Trilogue negotiations concerning Medical Device Regulation (2012/0266)
We are writing to you to express our views with regard to certain aspects of the European
Commission’s proposed revision to the legislative framework governing the approval and sale of
medical devices in the European market - and with a view to informing current negotiations
between the European institutions.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is Europe’s principal
trade body for small-to-medium sized enterprises working in the fields of pharmaceuticals and
medical devices. As the voice of over 900 companies across Europe, we seek to represent the
interests of the sector in discussions with policy makers at both the national and international
level.
EUCOPE wrote to Member State representatives in April 2015 to both welcome and comment
upon the Commission’s effort to further improve patient safety and public health by revising the
current legal framework for medical devices in the EU.
As trilogue negotiations are now well underway, we feel that it is necessary to re-iterate our
concerns surrounding a handful of issues that have yet to be fully resolved or clarified – namely
those concerning Article 3, Rule 21, Article 44 and Article 97 (of the original Commission
proposal).
Enclosed with this letter is a EUCOPE position paper providing more detailed rationale to the
arguments summarised below, together with suggested amendments for discussion.
Rule 21 – classification of substance devices
The Commission’s proposal stipulates that devices composed of substances or a combination of
substances intended to be ingested, inhaled or administered rectally or vaginally and that were
absorbed by or dispersed in the human body are to be classified as class III – in the highest risk
category.
Much progress has been made towards ensuring that this Rule is informed by scientific evidence
as opposed to unsubstantiated beliefs. EUCOPE welcomes the commitment to reach a
compromise that is based on whether a substance device is intended to be ‘systemically’
absorbed or not within the human body. The Council’s first reading position marks a sensible
approach to Rule 21. However, EUCOPE would like to support deleting one sub-clause.
The first paragraph of Rule 21 suggested by the Council, in combination with the last bullet point
(“in all other cases”), already places devices that are composed of substances or combinations of
substances that are being absorbed in the highly regulated risk class IIb, regardless of their exact
way of administration (except if they are applied on skin). Differentiating, or attempting to
differentiate, between those products “intended to be introduced into the gastrointestinal tract”
with medical devices which are intended to be introduced into the human body via another body
orifice, e.g. through the eye or inhalation, risks unnecessary confusion for both industry and
regulatory decision-makers.
EUCOPE amendment to Council’s First Reading Position on Rule 21
Devices that are composed of substances or combinations of
substances that are intended to be ingested, inhaled or administered
rectally or vaginally introduced into the human body via a body
orifice, or applied on skin and that are absorbed by or locally
dispersed in the human body are:
-
In class III if they, or their products of metabolism, are
systemically absorbed by the human body in order to achieve
the intended purpose
-
In class III if they are intended to be introduced into the
gastrointestinal tract and they, or their products of
metabolism, are systemically absorbed by the human body
-
In class IIb in all other cases, except if they are applied on
skin, in which case they are in class IIa
Article 3 – The Commission’s right to categorise products
Our position on Article 3 remains consistent with that presented to health ministers in June 2014.
Article 3 as currently worded allows for the Commission to ‘at the request of a Member State or
on its own initiative, by means of implementing acts, determine whether or not a specific product,
or category or group of products, falls within the definitions of 'medical device' or 'accessory to a
medical device'.
EUCOPE understands and supports the need for a process to determine whether a product falls
within the definitions of 'medical device' or 'accessory to a medical device'. It is essential however
that this process is conducted in a fair, transparent and coordinated way, ensuring that affected
parties are involved.
We are concerned that in the absence of formal consultation with directly affected parties, the
Commission’s power to determine the regulatory status of a product or group of products will lead
to uncertainty in the market, which could in turn affect the willingness of companies to invest in
certain products (that could be subject to re-classification at a later date).
EUCOPE is therefore calling on trilogue attendees to amend Article 3 or insert a new article to
allow for the introduction of a formal consultation process every time a product or group of
products is selected for review. We see no reason why this could not be issued electronically via
the Commission’s own website in a similar vein to existing online consultation platforms.
Even if the principle of consultation is implied within the current wording of the Commission’s text,
the extent of consultation and role of each party in this process remains unclear and therefore
subject to regulatory and legal uncertainty.
Consultation would inject some predictability into the proposed regulatory system and ensure that
all interested parties with scientific data relevant to the determination of classification have the
opportunity to submit data. This is in the best interests of both manufacturers and the
Commission itself, which is tasked with reaching an informed decision. If manufacturers choose
not to submit data to the Commission, this is their prerogative. However, given the potential longterm effects of the Commission’s eventual decision, and the lack of precedents for appealing
against an implementing act, it is essential that affected parties retain that right to input into the
decision-making process.
In this respect, consultation with the proposed Medical Device Coordination Group (MDCG), as
put forward by both the European Parliament and Council, would not by itself prove sufficient.
Only by consulting with directly affected parties will the Commission be able to reach a fully
informed decision as to the appropriate regulatory status of that product or group of products.
Should further amendment of Article 3 prove impossible, EUCOPE would hope that negotiators
would – by way of a compromise – see it fit to insert an obligation to consult with industry in the
text of Recital 8. Although not binding in the same vein as an amendment to Article 3, such an
insertion into the Recitals would demonstrate a commitment to transparency and provide
interested stakeholders with a measure of accountability and system of appeal.
Article 44 – Pre-market approval of devices
The Commission proposal provides for the establishment of a Medical Device Coordination
Group (MDCG). According to Article 44 of the proposal the MDCG shall, inter alia, scrutinise
conformity assessments for devices classified in class III and under certain circumstances for
devices in lower risk classes.
We recognise the political pressure within some Member States to implement a centralised
approval process for products classified in the highest risk category. That said, we would cast
serious doubt on the ability of such a system to prevent future instances of fraud or scandals such
as the one involving PIP breast implants. Instead, we believe that the introduction of a centralised
‘double check’ measure would only serve to delay market entry of innovative new products.
As an organisation, we have long argued that it is the scrutiny of notified bodies that needs
improving and the Commission has taken great strides towards this end in recent months.
That said EUCOPE accepts the political climate in which trilogue negotiators are operating and
the pressure to reach a compromise that adequately addresses the concerns of all three
European institutions. For this reason, EUCOPE supports the Council’s first reading position and
the creation of a new Article 42a – which is not only sensible but also feasible within the confines
of current resources and available expertise. We would urge both the Parliament and the
Commission to adopt this compromise, and in so doing, recognise the intense effort that has
gone into brokering this agreement between Member States over the last two years.
Article 97(2) - Transition periods
In order to avoid disruptions to the supply of existing products and investment in potential new
innovations, sufficient time is needed for companies to adapt to the new regulatory system.
The Commission’s proposal will lead to a significant conversion of the regulatory system not only
in relation to the classification system but also with respect to clinical evaluations and
investigations or the identification and traceability of devices. We would therefore recommend a
minimum transition period of 5 years rather than the current 3 years. This would align the medical
devices file with the Commission’s proposed changes to the framework governing in-vitro
diagnostic medical devices (IVD – COM (2012) 541).
Conclusion
EUCOPE fully supports efforts to improve patient safety whilst also delivering speedy access to
market for new innovative products. However in order for this dual objective to be realised,
changes to the regulatory framework need to be applied consistently across all devices and the
terms used in the legislation properly defined in order to minimise the risk of future gaps,
uncertainties and legal challenge.
We therefore ask all actors involved in the scrutiny of the proposed legislation to consider
carefully the above points and enclosed amendments, and if possible, incorporate them into ongoing discussions.
Should you require further detail on any aspect of the above, please do not hesitate to get in
touch. In the meantime, we wish you well in your deliberations.
Yours sincerely,
Dr. Alexander Natz
Secretary General
Dr. Oliver Sude
Legal Counsel