Draft Revision of EU Medical Devices Directive 93/42/EEC

Al Rosen

Leader
Super Moderator
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:



  • 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.
A copy of the draft revision document can be downloaded from:

www.bsiamericas.com/mddupdate
 
B

Bridget

Been watching for this...

Thanks Al,

I knew changes to the MDD were underway, thanks for the link

Bridget
 
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