The European Union (EU) adopted the Commission’s proposal to extend the Medical Device Regulation (MDR). The amendment was published in the Official Journal (OJEU) on 15 Mar 2023.¹ What does this mean for U.S. manufacturers? Here is a clinical perspective snapshot.

Medical devices marketed in Europe, prior to 2021, were approved (received CE Mark) by way of the EU Medical Device Directive (MDD). In May 2021, the European Commission (EC) enacted the MDR, a more stringent regulation that requires extensive clinical evidence on devices to validate safety and efficacy. Manufacturers pursuing a new device approval must have robust and specific clinical evidence on its device at the time of the CE Mark application to be considered for market clearance. For legacy devices, products that were already on the EU market, were given until May 2024 to satisfactorily transition from MDD to MDR.

SITUATION

For most MedTech companies, transitioning from MDD to MDR forced manufacturers to conduct new clinical trials on their devices to generate “sufficient” evidence that would satisfy the MDR’s safety and efficacy standards. For the last seven years, manufacturers have been burdened by the lack of existing clinical data, overwhelming costs associated with developing/executing new trials, and shortages of resources to execute studies – all to be complete and approved by 2024. If a manufacturer is unable to meet that deadline, their device(s) will be removed from the EU market; consequently, disrupting the EU healthcare systems and patients access to critical medical products. Unfortunately, this trend and trajectory quickly proved not to be enough time!
With this extension, the MDR transition period was extended from 26 May 2024 to:

• May 2026 for custom-made implantable devices
• Dec 2027 for all implantables and all class IIb devices
• Dec 2028 for class I devices

But let’s not get too excited…

PROBLEM

The new extension does not grant manufacturers more time! The extension permits the Notifying Body (NB) additional time to review documentations and issue MDR certificates, as they remain severely backlogged since 2019. Therefore, manufacturers must keep the same energy, pace, and persistence to obtain sufficient clinical data and prepare submissions as soon as possible. According to the EC, as of June 2023, a total of 13,177 MDR applications were received by NBs and only 3,899 certifications have been issued.² Overall, more than 85% of the 500,000+ devices on the EU market have not yet transitioned to the MDR.³ For further perspective, it takes 13-18 months on average for a NB to review and issue an MDR certificate – after the application enters queue. So, a manufacturer should begin the data collection (clinical study) and analysis process at least 2-3 years prior to the device’s MDD expiration date.
For some of us clinical and regulatory leaders, the race to MDR has been ongoing since 2016 and it has not gotten easier. The key issues have been (1) manufacturers are not prepared with “sufficient” clinical data for the lifetime of the device and (2) the NBs have not provided a clear definition of sufficient or lifetime, and (3) the NBs have not been equipped/staffed/certified to handle the overwhelming number of submissions. There’s still a great deal of interpretation and lessons learned to be had, such that U.S. manufacturers can truly be MDR-ready! What becomes the mitigation path?

SUGGESTIONS

To position your company for a timely and successful approach to MDR, check out the following lessons learned:

• Given that sufficient and lifetime clinical evidence continues to be chief barriers to MDR-readiness, manufacturers will want to be more innovative in how data is collected. It is a fact that conducting traditional clinical trials on every product within the transition timeframe has not been financially or operationally feasible for companies, even for blue chip giants. Manufacturers should be aware of the various alternative and innovative clinical strategies that can accelerate data gathering and try taking the least burdensome approach for patients.
• Manufacturers should submit applications with a Clinical Evaluation Report (CER) or technical file (TF) that is fully vetted and pressure tested by an expert. The NB will provide up to three rounds of deficiency responses and opportunities for conformity before removing your submission from queue – thereafter you will be required to start a new submission and subjected to another 13-18 month average process.
• Be prepared by submitting quality clinical data, which is classified as ISO 14155 and GCP compliant. Ensure there is confidence in knowing your evidence and operation, such that you are in a strong position to negotiate and defend your safety and efficacy profile with the NB. Also, have your post-market clinical follow-up plan (PMCF) protocol in place and ready to execute.
• Lastly, this extension does not give the manufacturer more time – so keep going!
  While the EU MDR journey has been considered disruptive, the updated regulation has set a path for more patient-centered healthcare where transparency and patients’ choice are a priority, and where patients can benefit from high-performing devices and new therapies.⁴
  That said, MDR is not a moment in time, we should fully accept that this is the new norm for marketing devices on the European market.

References:
1. European Commission – Council Vote on the Medical Device Regulation Extension (07 March 2023). https://ec.europa.eu/commission/presscorner/detail/en/statement_23_1504
2. European Commission – Notified Bodies Survey on certifications and applications (MDR/IVDR) (25 October 2023). https://health.ec.europa.eu/latest-updates/notified-bodies-survey-certifications-and-applications-2022-10-26_en
3. MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation (14 July 2022). https://www.medtecheurope.org/wp-content/uploads/2022/07/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation.pdf
4. European Commission – What is the Medical Devices Regulation about? (accessed 10 Mar 2023). https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24