Essentials of European Medical Device Regulatory Affairs

How to Apply the Rules

• Manufacturer decides on the basis of the decision rules in the Directive (Annex IX) and the intended purpose of the device

• Decision criteria: time, invasiveness, powered or not (active/non-active), presence of drugs

• All rules must be considered • For multipurpose devices the highest class applies

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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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