EMERGO SUMMARY OF KEY POINTS:
The German Medical Technology Association (BVMed), Germany's largest medical device industry trade group, has urged "immediate" implementation of legal measures by the European Commission to boost surveillance of Notified Bodies as well as market surveillance of medical devices.
This regulation outlines how Instructions for Use may be provided in electronic format to professional users for certain medical devices under the Medical Device Directive and Active Implantable Medical Device Directive.
A recent investigation by British journalists has brought to light questionable practices by certain European Notified Bodies, prompting greater urgency for medical device regulatory framework revisions proposed in September 2012.
The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs were released by the EU Commission with significant fanfare on 26 September 2012. The weaknesses cited in the Executive Summary/Impact Assessment of the EU regulatory system, were not a shock. The MDEG report (2002) had identified these as areas of concern. In reviewing the changes it became apparent to us there are several themes in the proposed legislation: Oversight of Notified Bodies, Post-market safety, Transparency and traceability, access to external expertise and management of the regulatory system. The impact of the PIP scandal was apparent.
European Union member states should take immediate steps to
European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a single industry trade federation to more effectively lobby on behalf of their medical device and IVD manufacturing members.
Two versions of a draft law amending regulations of pharmaceutical and medical technology products in France have been adopted by the French National Assembly and Senate.
In its latest annual report, German medical device industry trade group BVMed (Bundesverband Medezintechnologie) stakes out the group’s positions on German health policy, financing issues and medical device legislation, and also provides results of BVMed’s annual membership survey.