The Medical Devices Introductory Course 2020

Background and What’s new?

• MDR Entry into Force: 26 May 2017 • MDR Date of Application: 26 May 2021

• Are you already familiar with the Medical Devices Directive (MDD)? • If so, there are relatively few changes. The main changes are in red. • If not, don’t panic. The process is relatively straight-forward. • Hint: begin by getting a copy of the MDR – I can supply a bookmarked version.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment - What is it?

• Is “the process demonstrating whether the requirements of this Regulation (the MDR) relating to a device have been fulfilled ” – Article 2(40) • Places responsibilities upon Manufacturers (Ms) and upon Notified Bodies (NBs) • May require the M to have a Quality Management System (QMS) approved by a NB • Will require the M to create technical documentation for his device(s) • Is described in Article 52 and in Annexes IX to XI (MDD Article 11 and Annexes II to VII) • Depends on the product class – the higher the class, the more onerous the Conformity Assessment process.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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