& QA Consultancy
& QA ConsultancyWhen will the revised Medical Device Directive be published?
The revision is scheduled to start in September 2001 and be completed mid 2002.
What issues will the review focus upon?
The proposals for the review include;
- Reclassification of Implants
- the need to increase levels of Post Market Surveillance/ Post Market Feedback for ALL devices.
- more Clinical Data to further support performance Claims
What issues are Notified Bodies focussing on currently, during Medical Device audits?
- Recently, it has emerged that there is a distinct lack evidence of RA/QA departments being involved in the review and approval process of Advertising Literature. As a consequence, it has been found that Sales Brochures and Media Advertising Campaigns are making false or exaggerated Performance claims, which are not supported by the Clinical Data in the Technical File(s).
Our advice is to make sure that your procedures ensure Regulatory / QA involvement at the appropriate stages of a products Life Cycle. For example: Design Input and Design Output / Verification when "Labelling" issue are3 being reviewed and approved. Your procedures should also ensure that Changes to "Labelling" and also "New Labelling" after a Product launch has occurred, are subject to the appropriate RA/QA approval before release.
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