As the 26 May date of application for the Medical Devices Regulation (MDR) approaches, lingering concerns about notified body (NB) capacity, a lack of guidance and the two-year Eudamed delay are beginning to get more serious.
Earlier this week, industry group MedTech Europe outlined some of the challenges in a “call to action,” while also explaining the risk of device shortages. Currently, 55 NBs are legally allowed, until 26 May, to renew or extend the validity of device certificates issued under the former device directives, but their capacity to do so “is extremely limited, putting at risk the continued availability of existing devices.”
And with only nine NBs designated under MDR, future challenges await.
Maurits Lugard, a Brussels-based partner in Sidley Austin’s global life sciences practice, told Focus via email: “Even with experience gained from the MDR joint assessments and the anticipation that future assessments and accreditations will go faster, it will still be very difficult to ensure that enough Notified Bodies are designated by 26 May. Also, even if we did have a large number of Notified Bodies available, the fact that the MDR introduces stricter requirements means that the certification process itself may take more time than in the past. Lastly, we are still waiting for a large volume of guidance documents.”…