CEOC, EUROLAB and IFIA welcome the Proposal for a Regulation of the European
Parliament and of the Council on Medical Devices, published on 26 September
2012, aimed at revising medical device legislation. The Proposal will
strengthen the current European regulatory framework for medical devices and
will develop it further.
In particular, the proposed strengthening of the role of the notified
bodies within the overall system as independent control and surveillance bodies,
further development of product verification and more intensive market
surveillance will substantially improve European health and consumer
protection, and will increase the safety of medical devices on the European
In order to offer the
best-possible guarantee for the safety of medical devices in Europe, the
instruments and procedures for assessment, control and surveillance of such
devices should be consistently utilised to their full extent. They should be
transparent and clearly defined and should be uniformly applied. On this basis,
we would like to propose the following specific improvements:
1. Introduction of the EU type examination as an
obligatory procedure for conformity assessment for medical devices within the
highest risk class (Class III), which will take the approach of ‘hands-on
product’ testing and inspection supported by the European commission even more
strongly into account.
2. The notified bodies should all be obliged to
perform a defined number of unannounced visits for inspections and tests. The
scope and procedure for the unannounced inspections should not be laid down in
an “implementing act”, but - because of their extreme importance - should be
specified in the Regulation itself.
3. As the notified bodies do not have any
official authority to undertake direct interventions, and therefore the
collection of samples from the market by notified bodies alone is often not
possible in practice, the samples should in these cases be collected through
the competent authorities responsible for or cooperation with the market surveillance authority. The
notified bodies should all be obliged to obtain authority a specified number of
samples from the market for testing.
4. Integration of the notified bodies into the
exchange of information of the market surveillance authorities must be clearly
defined and extended. In particular, the notified bodies need to receive information
prepared within the framework of automated, consistent information flows in
order to be able to recognise developments, to allow new information to flow
directly into their work and to be able to react as rapidly as possible to
reports of incidents and events.
5. The requirements placed on the notified bodies must be regulated and
applied in a uniform manner throughout Europe, in order on the one hand to
achieve the same high levels of safety and quality in all the Member States,
and on the other in order to ensure a level playing field. Because of their
vital significance for the entire system, the establishment of the mandatory
requirements for the notified bodies should be undertaken by the European
Parliament alone, not by national legislators or authorities acting in
isolation. In addition, in order to avoid divergences in implementation, the
requirements should neither offer scope for interpretation nor should they -
even in terms of their detail - fall short of current legislation.
6. The notified bodies should be permanently
represented on a new Medical Device Coordination Group described in the
Proposal, in order that their practical experiences can be properly taken into
7. In the Proposal, reference is made to the
Code of Conduct as a document that has to be accepted and implemented by all
notified bodies. The Code of Conduct 
which is already in use by some notified bodies and which is obviously meant
here, is a document that was drafted in the form of a voluntary commitment
which is based on the legislation as it is today and which in addition is
subject to continual upgrading and change by the notified bodies. Therefore, in
order to ensure legal compliance, reference should not be made to such a document
in the Regulation. Instead, some individual items of content from the Code of
Conduct could, if appropriate, be directly included in the Regulation text.
8. Lack of clarity as regards the language used
and extensive scope for the interpretation of the text of the Regulation should
be eliminated as far as possible in order to achieve uniform Europe-wide
application of the legislation. The terms and definitions in the Proposal must
be coherent and used in a consistent fashion. In particular, further potentials
for optimisation should be utilised in the design of the conformity assessment
procedure by making the requirements as specific and concrete as possible; in
addition, international standards should be taken into consideration.
9. The Proposal requires rotation of the
notified body’s personnel involved in the assessment of medical devices.
Nevertheless this objective should be implemented in such a way that the
members of any audit team will always have the necessary expertise and
experience with the product to be assessed. This aspect grows in importance
with greater complexity of products and structures within a manufacturing
The competence of the notified bodies lies in technical testing and
assessment and not in business and product viability analysis. This fact should
be taken into consideration in the design of the audits.
10. In the Proposal, the market surveillance
authorities are placed under the obligation to evaluate medical devices
post-market by means of checks on the basis of adequate samples. In order to ensure a consistent level of control by these authorities in
all the Member States it would seem useful to harmonise interpretation with
regard of number of market surveillance actions or samples taken by them.
The adjustments outlined above are likely to
make a significant contribution to an increase in the safety of medical devices
for consumers in Europe.
We will make our expertise available in a
constructive way in future legislative procedures in order to achieve an
overall regulatory framework which looks towards the future - and which
guarantees rapid market access for innovative medical devices to the benefit of
patients, whilst at the same time offering the highest possible levels of
safety by means of intensified control activities.