Essentials of European Medical Device Regulatory Affairs - June 2020

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

TheOrganisation for Professionals in Regulatory Affairs

MDD - 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

TheOrganisation for Professionals in Regulatory Affairs

Example: Rule 6

Surgically invasive devices - transient use - Class IIa unless: • Intended to control, diagnose, monitor or correct defect of the heart or of the central circulatory system through direct contact -Class III (angioplasty balloon catheters) • Reusable surgical instruments - Class I (scalpels) • Intended for direct contact with the central nervous system - Class III (brain spatulas) • To supply energy in the form of ionising radiation - Class IIb • Intended to have a biological effect or to be absorbed - Class IIb • Intended to administer medicines by means of a delivery system, if in a potentially hazardous manner - Class IIb

66

22