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Strengthening Consumer safety: Improving the safety of medical devices
Today the European Commission adopted two measures to improve the
safety of medical devices fulfilling its commitment to restore patient
confidence in the medical devices sector following, amongst others, the Poly
Implant Prothèse (PIP) breast implants scandal.
The new rules are a Commission Implementation Regulation clarifying the
criteria to be met by notified bodies, which are responsible for inspecting
manufacturers of medical devices, and a Recommendation clarifying the tasks
these bodies have to undertake when they perform audits and assessments in the
medical devices sector, which covers some 10 000 types of products, from
plasters to pacemakers.
EU Commissioner for Consumer Policy, Neven Mimica, said that "with
today's measures the European Commission further strengthens the safety of
We now have a clearer basis for unannounced audits, sample testing, or
joint assessments by notified bodies.
Full clarity can only be achieved through amending the basic
I am committed to support the Parliament and the Council with a view to
completing the on-going revision by early next year."
The measures adopted today were announced in the Joint Plan for
immediate action agreed between the Commission and the EU Member States.
The plan focusses on the functioning of notified bodies;
the surveillance by the Member States of the products on the market, EU
coordinated investigations and responses to problems with specific devices as
well as improved transparency and communication between Member States, industry,
health professionals and notified bodies.
Most of the actions agreed upon have now been implemented or are under
The overall progress will be presented in a Commission Staff Working
Document to be published in October.
In addition, a pilot project of joint audits of notified bodies
undertaken by auditors from several Member States and the Commission was
launched earlier this year.
11 such audits have taken place and 8 more are planned before the end
of the year.
These actions have already, before the adoption of today's measures,
resulted two notified bodies been obliged to temporarily stop issuing
certificates until deficiencies have been corrected.
Examples of the strengthened requirements laid down in the measures
- A Member State shall only designate a notified body after a 'joint
assessment' conducted with experts from the Commission and other Member States.
The assessment reports shall be made available to all other Member
- Member States are required to carry out surveillance and monitoring
of the notified bodies at certain intervals to ensure that they continuously
live up to the requirements.
If this is not the case, the Member State must withdraw the designation
as notified body.
- Knowledge and experience requirements of the staff of the notified
bodies to be required by Member States are clarified.
- It is now required that notified bodies shall randomly perform
unannounced factory audits and, in this context, check adequate samples from the
Failure to carry out random checks will result in the suspension or the
withdrawal of the designation of the notified body.
- Where risks might be caused by the substitution or adulteration of
raw-materials, such as in the PIP-case, a notified body shall also check that
the quantity of finished products corresponds to the quantity of the crucial raw