Although I havent read the Draft Revision of EU Medical Devices Directive 93/42/EEC yet, I thought I would post this.
The European Commission has produced a draft revision of the EU Medical Devices Directive 93/42/EEC. This draft is very much a 'work-in-progress' document, but it provides medical manufacturers with some in-sight into the thinking of European regulators as to where European requirements might head.
Notable proposed changes include:
www.bsiamericas.com/mddupdate
The European Commission has produced a draft revision of the EU Medical Devices Directive 93/42/EEC. This draft is very much a 'work-in-progress' document, but it provides medical manufacturers with some in-sight into the thinking of European regulators as to where European requirements might head.
Notable proposed changes include:
- A clear European definition of clinical data and clarification of the role and need of clinical evaluations and post marketing clinical follow-up.
- The introduction of a European database for clinical investigations for Competent Authorities to effectively share information and experience with clinical investigations.
- A mechanism to allow the European Commission to permit 'E' labeling of devices.
- Clearer requirements for Notified Bodies to sample technical documentation across the range of devices carrying CE Marking during quality assurance conformity assessments.
- Change in the definition of central circulatory system to include aorta descendens to the bifurcatio aortae.
www.bsiamericas.com/mddupdate