Legislative Review
This article was originally published in RAJ Devices
Executive Summary
European Commission extends public consultation on directive “recast”
European Commission extends public consultation on directive “recast”
The European Commission has extended the comment period for its controversial public consultation proposing to “recast” the medical devices directives1,2. While the comment period officially expired on 2 July, the commission has informally extended the deadline until the end of July, a spokesperson told RAJ Devices.
The consultation was launched because the commission believes that the current regulatory system does not offer a uniform level of public health protection - despite the revisions to the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) that were finalised last year3. Stakeholders have raised concerns over the appropriateness and timing of the consultation, which was launched before the 21 December 2008 deadline for member states to transpose the amended medical devices directives (Directive 2007/47/EC) into national law, and before the “new approach” revisions had been finalised4. (The new approach legislation, which was adopted on 23 June, contains new rules relating to notified bodies, market surveillance, device imports and CE marking, among other things.)
The European medtech industry has also criticised the commission for stating that there are substantial problems with the regulation of devices in Europe5. “There is no evidence-based justification” of the need for an overhaul, said several industry associations, including Eucomed, the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) and the European Diagnostic Manufacturers Association.
The commission has defended its actions, saying the consultation addresses “known areas of improvement in the legislative framework now and looking five, ten or even 15 years into the future”, ie beyond the implementation dates of Directive 2007/47/EC and the new approach legislation6.
References
1. European Commission, Recast of the Medical Devices Directives: Public Consultation, 6 May 2008, http://ec.europa.eu/enterprise/medical_devices/consult_recast_2008_en.htm
2. The Regulatory Affairs Journal - Devices, 2008, 16(3), 190
3. The Regulatory Affairs Journal - Devices, 2008, 15(6), 402
4. RAJ Devices Online, 2 July 2008
5. RAJ Devices Online, 9 July 2008
6. RAJ Devices Online, 13 June 2008