Search Eucomed  

Review of the Medical Devices Directives: Eucomed welcomes European Parliament Vote on 29 March

Brussels, 2 April 2007 - Eucomed, the European Medical Technology Industry Association, welcomes the European Parliament's overwhelming support for the Ulmer report on the review of the Medical Devices Directives¹. The positive vote came after the Council, the Commission and the Parliament, reached an agreement addressing a number of outstanding issues in product labelling, classification and transparency. Eucomed is pleased that the revised text further enhances patient protection without hampering medical progress and innovation. In particular, the legislator has maintained all the fundamental principles, which have ensured a high level of safety and performance of medical devices for over a decade. 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 use of reprocessed "single use" products.

Areas for further action:

1. 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.
2. Secondary legislation through comitology to allow the use of alternative means (CDRom, website, etc) for the delivery of instructions for use.
3. 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 Products². An expert group will be set up for this purpose.
4. Creation of a working group to evaluate the impact on patient health and safety of the use of reprocessed "single use" medical devices³.
5. 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.

Background information

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. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €3,7 billion in R&D and employs near to 445.000 highly skilled workers.

Medical Technology is characterised by a constant flow of innovations, which are achieved by a high level of research and development within the industry, combined with close co-operation with the users. Products have an average lifecycle of only 18 months before an improved product becomes available. In order to maintain high levels of product performance and patient safety, the industry invests heavily in regular user training.

The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.

Useful links

• Ulmer Report
• Eucomed backgrounder
• Commission's medical devices website.

More information

Mark Grossien
Communications Director

mark.grossien(at)eucomed(dot)be

+32 (0)2.775.92.24

¹ Rapporteur: Thomas Ulmer MEP - Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC - Vote in plenary on 29 March - 645 votes in favour
² See Eucomed backgrounder on advanced therapies
³ See Eucomed backgrounder on reprocessing of SUDs