Module 19 2021

02/06/2021

MDR/IVDR timelines

12 months

2016

2017

… 2020

2021

2022

… 2024

MDR

Original date of application

Revised date of application

Majority of AIMDD/MDD certificates

expire (c10K)

Regulations come into force

Text agreed

IVDR

Date of application IVDD certificates

IVDD certificates expire (c500)

start to expire*

Today

*Most IVDs (c10K+) have no certificate

13

IVDR/MDR Notified Bodies

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

14

7