What is the EU MDR?
The European Medical Device Regulation 2017/745 (MDR) is the new set of regulations applying to all medical devices intended for market in the EU, replacing the previous Medical Device Directives (MDD) and Active Implantable Medical Devices Directive (AIMD).
What is the purpose of the transition to the new MDR?
The purpose of the new MDR regulatory framework is to offer a higher level of protection of health for patients and users through more robust conformity assessments. These updates are informed by issues identified within previous regulations as well as MedTech advancements.
When does the MDR go into effect?
New device submissions must comply with the MDR as of 26 May 2021. Devices already on the EU market have a defined transition period set forth by the MDR. The MDR previously stated that the final transition period would end by May 2024.
Now, the MDR transition has been extended, with high-risk devices having a new deadline of May 2027 and low- and medium-risk devices a deadline of May 2028. Class III custom-made implantable devices, which were not initially covered by Article 120(3) of MDR, now have a deadline of May 2026.
Devices with a clearance expiring prior to the new deadlines will then also be required to resubmit under the new MDR and no devices will be grandfathered under the MDR.
Why was the MDR delayed?
The European Commission (EC) proposed the MDR transition delay to help ease pressure for manufacturers and notified bodies struggling to keep up with the new regulations. Despite significant progress, tens of thousands of medical devices were not on track to meet the new MDR requirements, creating a risk of removal of these devices from the EU market. To avoid a shortage of critical medical devices, which would put patient safety at risk, the European Parliament voted overwhelmingly to accept this transition on 16 February 2023 and increase the transition timeframe.
What are some of the changes coming from the MDR?
Key changes include:
- A wider scope of regulated medical devices—some devices will be “up classified”
- Greater pre-market scrutiny for high-risk devices
- More stringent clinical evidence and documentation requirements
- A strengthening of post-market surveillance
The full MDR text can be viewed for additional details.
How can manufacturers comply with the new MDR?
It’s important for manufacturers to develop a clear strategy to comply with the MDR and to conduct a gap analysis if needed.
As you plan your MDR transition strategy, you may need help understanding the requirements or want someone to assess your current readiness for compliance. Consultants, such as our expert advisors at Nelson Labs, help manufacturers bring their devices into compliance with the new MDR.
For assistance in meeting these requirements, call us today at (801) 290-7500 or email us at [email protected].
For support navigating regulatory requirements, contact our Regulatory and Advisory Services experts.