Essentials of European Medical Device Regulatory Affairs - June 2020

MDR Transition Strategy

• Delay by one year, so more time available, less resources for AIMD? • Switzerland and Turkey extra year applicable. • UK _ Brexit is 31 st December 2020 • Is my QMS and technical documentation ready? • Is my supply chain ready? (distributors, importers) • When does my certificate expire? • Is my current Notified Body designated to the MDR? • Does my current Notified Body have the correct scope for my devices? • Do I want to make any significant design changes soon? • What about my new devices?

Notified Body Designation: https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

4

Medical Devices Regulation 2017/745 (MDR)

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20170505&from=EN

Since publication there have been two corrigendums (corrections) published

• May 2017 https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:32017R0745R(02)&qid=1585043243768&from=en

• November 2019 https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf

• Delay https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN

•Examplesofdirectives that couldalso impactdevices •Electromagneticcompatibility

Directive2004/108/EC

•Personalprotectionequipment

Directive89/636/EEC Directive2014/53/EU

•Radioequipment (RED)

There is the regulation, but then MEDDEVs and MDCG guidance to help

5

Transitional provisions “The Grace Period”

Article 120 MDR

Certificates issued under the directives: Certificates issued prior to 25 May 2017 remain valid for the period indicated on the certificate Certificates issued during the transition period remain valid for the period indicated (maximum 5 years), but become void on 27 May 2024 Example:

• Certificate issued May 2019 – expires May 2024 • Certificate issued Jan 2020 – void 27 May 2024

6

2