At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline. Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling products in the EU to have MDR certifications for not only new innovative products but also approximately 25,000 legacy products that have been sold in the EU market under the previous MDD certifications for many years.
Since implementation of the new MDR requirements in 2017, only 5% of the 25,000 certifications needed have been issued. Furthermore, due to the discussed capacity constraints of the notified bodies, which have struggled to come up to speed, increase resources, and train these new resources (which takes eighteen months), it is predicted that only 6,340 certificates will be issued per year between now and May 2024. If you do the math, that means the total number of certificates issued by the due date is expected to be roughly 14,000 out of 25,000.
Let that sink in for a moment… on May 26, 2024, the remaining 11,000 or 44% of legacy medical devices on the EU market will be pulled off the shelves, taken out of hospitals, and be inaccessible to patients that rely on them until such time that they receive certification.
This will have an enormous impact on patients and companies. This could be like a wrecking ball going through a lot of small and medium-sized companies, many of which manufacture orphan products for underrepresented patients. It is predicted that 10% of medical device companies in Germany will have to close their doors as well and 30% of previously marketed medical devices will not be available.
Furthermore, it was proclaimed that, since review and issuance of each certificate takes eighteen months, there are only six months left for companies to decide whether they will submit documents for MDR certification or risk losing their legacy certificates.
“There are no plans to come up with any further solutions,” a competent authority exclaimed, and those words seemed to weigh heavily on many of the industry attendees. While competent authorities are asking for pragmatic solutions to consider, there doesn’t seem to be a lot of wiggle room for considering solutions outside of the current framework.
Ironically, earlier in the conference, during one of the opening sessions, there were discussions about the perceived migration of companies in the EU to the U.S. due to the currently less-restrictive regulatory environment. This is in sharp contrast to the view of previous generations, on both sides of the pond, which perceived the U.S. regulatory environment as more difficult for gaining approvals and, therefore, launched products in the EU first!
Oh no! Could this be another “new normal”?