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Eucomed welcomes EU Health Council adoption of the medical devices directive

Brussels, 1 June 2007 - EU Health Ministers have endorsed on 31 May the report on the review of the Medical Devices Directives, accepting the compromise package adopted on 29 March by the European Parliament. This is good news, according to Eucomed, the European Medical Technology Industry Association.

Eucomed notes with satisfaction that the legislator has confirmed all the fundamental principles, which have ensured a high level of safety and performance of medical devices for over a decade. As hitherto, the text agreed by the Health Ministers puts patient protection first, and it supports medical progress and innovation. It will also improve the functioning of the internal market, and strengthen the competitiveness of European industry.

Guidance documents and secondary legislation will now have to be developed in order to ensure that the new provisions are adequately implemented. Work is also urgently required to evaluate the impact on patient safety of the reuse of reprocessed "single use" products.

Areas for further action:

• Guidance to Notified Bodies for the application of the new requirements for class IIa devices (hearing aids, blood filters, patient monitors, etc), in order to ensure a balanced level of scrutiny for small companies.
• Secondary legislation through comitology to allow the use of alternative means (CDRom, website, etc) for the delivery of instructions for use.
• Amendment of the medical devices directives so as to cover all products containing human derived cells and tissues, which will not be included within the scope of the new regulation on Advanced Therapy Medicinal Products. An expert group will be set up for this purpose.
• Creation of a working group to evaluate the impact on patient health and safety of the use of reprocessed "single use" medical devices.
• Review of the guidance document on clinical investigations to help manufacturers and Notified Bodies implement the new requirements relating to the notification of adverse events.

Useful links

• Medical Devices Vademecum
• Backgrounder on the Medical Devices Directive

About Eucomed

Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability, including ATMPs. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,8 billion in R&D and employs near to 435.000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.

More information

Mark Grossien
Communications Director

mark.grossien(at)eucomed(dot)be

+32 (0)2.775.92.24