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EU Medical Devices Directive M5 Amendment 93 42 EEC Regulatory Update - BSI British Standards presentation

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BSI British Standards Institution
BSI British Standards Institution

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.

Health & MedicineBusinessTechnology
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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
Content ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1. Revision of the EU medical device directive
History ,[object Object],[object Object],[object Object],[object Object]
Main Findings of Report ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
2. Implementation of the revised directive
Timescales for Implementing ,[object Object],[object Object],[object Object],[object Object]
Q&A around amended MDD ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Q&A around amended MDD ,[object Object],[object Object],[object Object],[object Object],[object Object]
State of play certificate changes ,[object Object],[object Object],[object Object],[object Object],[object Object]
3. Key changes
Key MDD Changes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Essential requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Impact on QA Assessments - General ,[object Object],[object Object],[object Object],[object Object],[object Object]
Impact on QA Assessments - General ,[object Object],[object Object]
All Annexes Document Retention Times ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Confidentiality ,[object Object],[object Object],[object Object]
4. Changes to clinical requirements
Key MDD Changes – clinical ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key MDD changes – clinical data
Annex X – Clinical Evaluation ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical investigations ,[object Object],[object Object]
5. Introduction of technical file sampling
Key MDD changes TF sampling IIa and IIb Devices ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key MDD Changes – Definitions ,[object Object],[object Object]
GMDN – a method of grouping devices
Technical Documentation Sampling by Notified Bodies ,[object Object],[object Object],[object Object],[object Object],[object Object]
BSI approach to sampling ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Class IIa – Device subcategory
Latest NBOG Guidance on TF sampling, reduced sampling numbers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sampling –BSI approach ,[object Object],[object Object],[object Object]
Depth of Assessment of Technical Files ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sampling conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object]
6. Impact revision on technical or design dossiers
2007/47/EC Impact on Technical Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Design Examination or Type Examination Certificates ,[object Object],[object Object],[object Object]
2007/47/EC Clarifications on Technical Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is next? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Relevant links ,[object Object],[object Object],[object Object],[object Object]
[object Object]
© Copyright The British Standards Institution 2010

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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
  • 2.
  • 3. 1. Revision of the EU medical device directive
  • 4.
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  • 6. 2. Implementation of the revised directive
  • 7.
  • 8.
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  • 17.
  • 18. 4. Changes to clinical requirements
  • 19.
  • 20. Key MDD changes – clinical data
  • 21.
  • 22.
  • 23. 5. Introduction of technical file sampling
  • 24.
  • 25.
  • 26. GMDN – a method of grouping devices
  • 27.
  • 28.
  • 29. Class IIa – Device subcategory
  • 30.
  • 31.
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  • 34. 6. Impact revision on technical or design dossiers
  • 35.
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  • 40.
  • 41.
  • 42. © Copyright The British Standards Institution 2010

Editor's Notes

  1. 17