Brussels, 18 April 2006 - Eucomed, the European medical technology industry association, welcomes the Commission's draft proposal reviewing Directive 93/42/EEC, which establishes a harmonized regulatory framework for marketing medical devices in the European Union. Eucomed has however made a few recommendations on the scope of the Directive as well as on the provisions relating to hybrid products; transparency; e-labelling; ergonomic design and product classification.
"The challenge for the regulator is to ensure that patient safety is safeguarded whilst at the same time supporting and encouraging innovation and facilitating rapid and equitable patient and clinician access to that innovation. This challenge has been met. All Member States and the European Commission are satisfied that the medical devices directive has by and large met their expectations. No major modification has been proposed by the Commission in the review process", commented Eucomed Director General Maurice Wagner, "After an in-depth analysis of the Commission's proposal, Eucomed would like to recommend some clarifications and fine-tuning to ensure that the specificity of certain highly innovative products such as computer-assisted surgical tools or drug-eluting stents is reflected in the text".
Eucomed suggestions:
A. CLARIFICATION OF THE SCOPE
B. HYBRID PRODUCTS
The original provisions of the directive relating to hybrid products such as drug-eluting stents adequately addressed their specificity and only required updating. The proposed text creates unnecessary hurdles.
C. TRANSPARENCY
The modalities for providing information to the general public and the user should be more realistic.
D. E-LABELLING
The use of state-of-the-art means of communication for the instructions for use of medical devices (CDRom, Internet) should be permitted by the revised Directive.
E. DESIGN AND ERGONOMICS
The new provisions on ergonomic design are unnecessary, as the directive already addresses this important aspect via the risk analysis process.
F. CLASSIFICATION
The revised text includes provisions that could affect the classification of several wound care products without justification.
Mark Grossien
Communications Director
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
