Essentials of European Medical Device Regulatory Affairs - October 2019

Impact of classification

• The choice of conformity route depends on classification • Article 11 MDD indicates choice of annexes to be followed e.g. Class IIb Annex II (full quality system) or Annex III plus Annex IV or V or VI.

• MDR refer to Chapter V Article 52. e.g. Class IIb

Chapter I and II of Annex IX and section 4 or Annex X plus XI.

NB involvement differs per route

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Currently - 18 rules

Rules 1 - 4

Non-invasive devices

Rules 5 - 8

Invasive devices

Rules 9 – 12 Active devices

Rule 13- 18 Special rules

http://ec.europa.eu/DocsRoom/documents/10337/attachments /1/translations

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