Free movement of safe products: NLF
Are you ready for the New Legislative Framework?
The European Union has developed an extended package of modernized rules and regulations, the
“New Legislative Framework” (NLF), which applies to all products sold on the European market. It is
a complete normative system that strengthens and completes the existing rules by trying to include all
possible aspects of safety, quality and traceability of products that enter the EU market.
The implementation of the NLF, which will come into force in April 2016 for measuring instruments,
has implications for your business. You will need to ensure that you are prepared for the forthcoming
changes. NMi can help you to understand the implications and the steps you have to take to prepare
yourself.
A NEW SET OF RULES, WHY?
IMPLICATIONS FOR YOU
The NLF was approved in 2008 by the European Committee,
evolving from the New (1985) and Global (1989-1990)
Approach. It consists of two complementary parts: NLF
Regulation (the legal basis for accreditation and market
surveillance) and NLF Decision (for harmonization of EU
product legislation).
During the first months of 2014, the new MID (2014/32/EU) and
NAWI (2014/31/EU) Directives have been published and they
will be implemented as of 20th April 2016. These harmonized
European Directives containing the essential requirements
for measuring and weighing instruments fit perfectly into
the wider scope of the NLF which also includes e.g. ATEX and
other Directives.
The main reason to establish the NLF within Europe is to
ensure the health and safety of the general public and to
reduce the number of products on the market which are
not satisfying the requirements set out in EU legislation. The
framework is designed to increase product compliance, to
provide equal opportunities in the European market and to
protect consumers from unsafe products, including imports
from third countries.
Furthermore, the NLF tries to simplify the regulatory
environment within Europe. The roles and obligations of
all stakeholders in the supply chain of products are clearly
defined. These stakeholders (manufacturers, authorized
representatives, distributors and importers) are called
‘economic operators’. Products that are traded between
economic operators need to be traceable within the supply
chain at all times. Market surveillance rules will become much
stricter and require that all products placed on the European
market are of good quality. Consequently, testing and
certification by accredited Notified Bodies like NMi will play
an even more important role.
We offer you full, future-proof conformity assessment
services that are in accordance with NLF legislation.
NMi
It is clearly stated in the NLF that after 20 April 2016, all
economic operators need to take appropriate measures to
ensure that they only ‘make available’ measuring instruments
which are in conformity with the MID or NAWI directive,
with special attention to health and safety issues. Until that
date, you have the time to anticipate on the additional
requirements.
NMi is accredited by the Dutch Accreditation Council (Raad
voor Accreditatie – RvA) and registered as a Notified Body for
both the MID and NAWI Directives.
We are there for you to inform you about the new requirements
that need to be taken into account, such as:
Placing on the market and making available
A product is placed on the market when it is made available
for the first time on the EU market. Any subsequent operation
(e.g. from distributor to distributor, from distributor to
consumer) is defined as making available.
Whether you are manufacturer, distributor or importer, you
will be responsible for the quality and safety of your product
as soon as you start a commercial activity for that particular
product. This moment is referred to as making available. Even
at the very beginning of your marketing process, for example
when showing a new measuring instrument at an exhibition
or on your website, the products need to be compliant with
the relative legislation.
Traceability
It is required that a measuring instrument is traceable
throughout the whole distribution chain. This facilitates the
tracing back of a non-compliant product to the manufacturer.
It’s for this reason that every economic operator should be
identifiable by indicating his registered (trade) name or trade
mark and postal address on the measuring instrument.
Market Surveillance
Market surveillance consists of controls by the national
market surveillance authorities after a product has
been placed on the market. New, strengthened
enforcement rules will help surveillance authorities
to prevent unfair trading conditions and to improve
product safety within the EU. These rules not only
apply to products within Europe but also to products
entering the European market from third countries. It
is the responsibility of every economic operator to bring
products into compliance with all the requirements set out in
the relevant EU harmonization legislation (MID and NAWI for
measuring instruments).
Conformity and risk assessment
A manufacturer is responsible for the conformity assessment
of his product. He needs to verify whether his product
complies to the regulatory requirements before it is placed
on the market, both during the design and production phase.
Even when design and/or production are subcontracted, the
manufacturer still remains responsible for the conformity
assessment.
A Notified Body acts under the control of national authorities
and receives its accreditation on a yearly basis after thorough
inspection. Once a product is approved by a Notified Body, a
CE marking on the product shows all stakeholders that public
health and safety is guaranteed.
An adequate analysis and assessment of the product risk(s)
are now part of the conformity assessment, for which the
manufacturer is responsible. Depending on the applicable
Directive, the risk analysis of the product can often be required
for the certification. In that case, it has to be included in the
technical documentation.
THE QUALITY CHAIN TO A HIGHER LEVEL
With the augmented responsibility for manufacturers, the
Notified Bodies who perform conformity assessment on the
products need to make sure that they properly perform the
tasks imposed on them. On their turn, the Accreditation
Bodies that control the Notified Bodies have to sharpen
their surveillance tasks. Finally, the national authorities who
appoint the Accreditation Bodies are responsible for a proper
enforcement policy. These improvements will lift the entire
quality control chain to a higher level.
THE BLUE GUIDE
The Blue Guide is an important reference and guidance
document intended to contribute to a better understanding
of the NLF. Click here to download the Blue Guide.
Q&A
NMi’s experts, who are directly involved in the study and
practical implementation of the NLF for the MID and NAWI
directives, already have collected the FAQ’s regarding the NLF
and its consequences:
Is it mandatory to change my certification to the new Directive
by 20th April 2016?
My Notified Body isn’t re-notified by 20th April 2016.
Is this going to give me problems?
I still have instruments in stock. Can I sell them
after 20th April 2016?
Does the NLF also have an influence on my Evaluationor Parts Certificates?
I don’t have an importer in Europe. Can I still sell my
instruments in the EU?
For weighing instruments: Do I have to change the green M
to the CE marking now this is changed in the NAWI Directive?
These and many other issues will be addressed during
dedicated training sessions, lectures and seminars organized
by NMi in the course of 2015. Keep an eye on our website
and our LinkedIn page to learn when these courses and events
will take place and how to subscribe. We will also inform you
about the latest developments in our newsletters, to which
you can subscribe by clicking on the button on our homepage.
GET INFORMED NOW!
Don’t hesitate to contact us regarding this subject and to
make an appointment to discuss your scope of products with
regard to the NLF in person. You can reach us by calling +31 78
633 23 32 or by sending an email to [email protected]
www.nmi.nl