The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of brand new educational content brought to you by RQM+ subject matter experts.
Date of Application
26 May 2021 - All medical devices and related procedures, systems, and documentation in the EU must comply with the new MDR by this date in order to enter the market. Certificates issued under the MDD before this date may remain valid for up to three additional years.
If you make a significant change to your MDD certified device, you will be required to obtain MDR certification.
All devices, whether MDD or MDR certified, must have EU MDR PMS, Vigilance, and Market Surveillance on the date of application. Registration via the ACTOR module of EUDAMED is strongly encouraged.
Next Important Dates
26 May 2022 - EUDAMED and PSURs
EUDAMED is scheduled to be launched starting a 24-month clock to enter data. PSURs are required for all Class IIb and III devices (unless PMS plan has an earlier date).
26 May 2023 - PSURs for Class IIa
PSURs are required for all Class IIa devices unless the PMS plan has an earlier date.
26 May 2024 - Last Market Date
Any unexpired notified body certificates issued under MDD will become void on this date. All devices placed on the market must conform to EU MDR. Sell-through provision starts for MDD devices already on the market. Class I devices that require a notified body must be compliant with EU MDR.
26 May 2025 - Last Service Date
This is the last possible date for putting MDD devices into service that were already on the market.
New MDR Resources
Expert Content from the rqm+ KnowLEdge center
- Whitepaper: Three Key Stages - Three Common Pitfalls: Post-Market Clinical Follow-up Under MDR
- MDR Post-Market Clinical Follow-up Checklist
- Optimizing your Technical Documentation to reduce NB review time and questions
- How to Obtain CE Marking Under the MDR
- How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR
- Top 4 Findings from Notified Body Technical Documentation Audits Under EU MDR
- 8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9
- #36 Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2
- #35 Preparing for PSURs
- #34 Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions
- #33 Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 1
- #32 What if I'm not ready for EU MDR on May 26, 2021?
These are available on our Device Advice Podcast, too!