EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation
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BSI British Standards' presentation of EU Medical Devices Directive M5 Amendment 93 42 EEC regulatory updates. Presented at the HKTDC Hong Kong International Medical Devices and Supplies Fair 2009. By Jan van Lochem, Gert Bos and Suzanne Halliday. Seminar “Regulatory update on medical devices in Asia and EU”. It covers the revision of the EU medical device directive, implementation of the revised directive, the key changes, changes to clinical requirements, introduction of technical file sampling, and the impact revision on technical or design dossiers.
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EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation
- 1. M5 Amendment of EU Directive 93/42/EEC - regulatory update Jan van Lochem – Gert Bos – Suzanne Halliday 5 November 2009 HKTDC Hong Kong International Medical Devices and Supplies Fair 2009 Seminar “Regulatory update on medical devices in Asia and EU” For more information on healthcare standards visit: http://shop.bsigroup.com/healthcarestandards
- 3. 1. Revision of the EU medical device directive
- 6. 2. Implementation of the revised directive
- 11. 3. Key changes
- 18. 4. Changes to clinical requirements
- 20. Key MDD changes – clinical data
- 23. 5. Introduction of technical file sampling
- 26. GMDN – a method of grouping devices
- 29. Class IIa – Device subcategory
- 34. 6. Impact revision on technical or design dossiers
- 42. © Copyright The British Standards Institution 2010
Editor's Notes
- 17