The Medical Devices Introductory Course 2020

• Is Full QMS including Design, Manufacture, etc and assessment of TD • There are three chapters: Chapter I: QMS (S1-S3) Chapter II: Technical documentation (S4-S6) Chapter III: Administrative provisions (S7-S8) • The QMS and the TD must be assessed and certified by a NB. Upon completion the NB issues: – 1) an EU QMS Certificate and – 2) an EU Technical Documentation Assessment Certificate for class III and class IIb implants • Used especially for class III and class IIb Annex IX: QMS and Technical Documentation (MDD Annex II including Annex II.4)

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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• Extra requirement • Applies to class III implants and class IIb active devices intended to administer and/or remove a medicinal product • “The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation … to the Commission. The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106.” • The expert panel may decide to provide a scientific opinion Annex IX.5.1: Further scrutiny for high risk devices - New

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

16