Essentials of European Medical Device Regulatory Affairs

MD Directive

35 Whereas… = Why

Annex I: Essential Requirements Annex II to VII: Procedures to demonstrate conformity Annex VIII: Devices for special purposes Annex IX: Definitions, Classification Rules Annex X: Clinical Evaluations Annex XI: Notified Bodies Annex XII: CE mark

23 Articles = What

XII Annexes = How

Total of 60 Pages

The Organisationfor Professionals inRegulatory Affairs

MDR (EU) 2017/745

Chapter I – Scope and Definitions Chapter II – CE Marking, Economic Operators, Reprocessing Chapter III – Identification and Traceability of Devices Chapter IV – Notified Bodies Chapter V – Classification and Conformity Assessment Chapter VI – Clinical Evaluation and Investigation Chapter VII – Vigilance and Market Surveillance Chapter VIII – Cooperation between Member States Chapter IX – Confidentiality, Data Protection, Funding, Penalties Chapter X – Final Provisions

101 Whereas = The Why

10 Chapters of 123 Articles (The What)

XVII Annexes = The How

Total: 177 Pages

The Organisationfor Professionals inRegulatory Affairs