During a December meeting of the European Union’s Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), European Commissioner for Health and Food Safety, Stella Kyriakides, confirmed that the May 2020 deadline for Medical Device Regulations (MDR) implementation will not change. See the recording of the December 9 public session with comments from representatives across the EU (beginning around 1:37) here. Commissioner Kyriakides brief comments begin around 2:09:10.
Below are highlights from the session and few of our takeaways from the impending deadline:
- The May 26, 2020 Date of Application of the new regulation remains unchanged despite the EUDAMED database delay.
- 700 experts have applied to serve on the new medical device expert panels.
- A key pre-requisite for some implantable - & Class III - devices and Article 12 devices (Class IIb devices that channel medicines to or from the body) that may be subject to Clinical Evaluation Consultation Process (CECP).
- The postponement of the EUDAMED database does not impact the application of the regulations.
- In other words, the EUDAMED delay should not be used as an excuse for manufacturers not to comply with the MDR.
- Another three Notified Bodies (NBs) were expected to be designated before the end of 2019.
- Assuming a maximum of ten NB’s were designated under the MDR by 2019 year-end, this is still well short of the 20 promised by the EU Commission in 2019 and significantly less than 56 NB’s currently designated under the MDD.
- This implies that NB’s will continue to be overloaded for the foreseeable future and will be less tolerant of Technical Documentation submissions that are deemed to be “non-compliant”, more so, with the capping of rounds of Q&As.
Given the inescapable tug-of-war between medical device manufacturer's competing business priorities, we strongly encourage you to act quickly and not to wait until May 2020 to start scrambling. The new MDR requirements take time, resources, and a lot of planning so most organizations need outside support to structure the transition in alignment with their business goals.
As always, R&Q will continue to work closely with our clients to ensure that Technical Documentation submissions are Notified Body (NB) compliant. In the meantime, we encourage our clients to reach out to their R&Q account contact to discuss their MDR transition plans.
1) European Council. Council of the European Union. Employment, Social Policy, Health and Consumer Affairs Council Public Session Webcast. Recorded December 9, 2019. Accessed January 6, 2020. https://video.consilium.europa.eu/en/webcast/9d6c51fc-df68-4480-9cdd-72dade2365ab
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