Navigating the Latest 2024 Updates to the EU Medical Device Regulation (MDR)
For those in the medical device space, you and your team are probably very much aware of the ongoing EU Medical Devices Regulation (MDR) update, and its importance to the medical device market landscape. The EU MDR has replaced the previous Medical Device Directive (MDD) (93/42/EEC) and included important updates such as increased requests for clinical data and increased standards regarding bench testing, among others.
Important Changes for 2024
Important Timeline Shifts Relevant to 2024
We’re quickly approaching the halfway point of 2024. I know, we can’t believe it either! On January 6, 2023, the European Commission proposed an extended transition time for certain medical devices depending on their risk classification. It is important to note that the standards for safety and performance proposed in the EU MDR have remained the same, manufacturers are now just being allotted extra time to reach the new regulation’s requirements. Specifically, Class III and Class IIb implantable devices now have until December 31, 2027 (previously May 26, 2024) to meet the new EU MDR requirements, and all other risk classes (i.e., Class IIb non-implantable, Class IIa, and Class I devices) have until December 31, 2028 (previous May 26, 2024). These dates will allow manufacturers more time to get certified by Notified Bodies under the EU MDR (preventing potential market shortages), and more time for more Notified Bodies to qualify for being able to conduct an EU MDR review.
New Guidance Documents
If you’re familiar with the EU MDR, you’ve probably already heard of the Medical Device Coordination Group (MDCG) guidances. Nine additional MDCG guidances have already been released for 2024, and include:
· MDCG 2024-1: Device-Specific Vigilance Guidance Template
· MDCG 2024-2: Procedures for the updates of the European Medical Device Nomenclature (EMDN)
· MDCG 2024-5: Guidance on the Investigator’s Brochure Content
· MDCG 2024-6 through MDCG 2024-9: Preliminary assessment/re-assessment review templates
Many of the new MDCG guidance related to strengthened post-market surveillance, adjustments needed for compliance, introductions to the upcoming rollout of required EU reference libraries, and device-specific requirements, such as updated procedures for in-vitro diagnostic devices.
In Conclusion: Let’s Talk Benefit-Risk
(See what I did there?) There are of course benefits to extended transition periods: first and foremost, they allow manufacturers to make the adjustments needed to ensure full compliance before the extended EU MDR deadlines. This in turn can result in improved safety and efficacy of the medical devices on the current EU market. The new MDCG guidance already proposed in 2024 offers enhanced support and guidance for compliance, and support procedures that will streamline device approval and market entry processes.
Still worried about the upcoming 2027 EU MDR deadlines, or how the new guidance documents affect your device? Minola Scientific can help.