The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers.
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
The angst over the maladroit roll-out of the European Union’s Medical Device Regulation (MDR) has reached the European Parliament (EP), which met recently to address the issue. Stella Kyriakides, who oversees the MDR on behalf of the European Commission (EC) responded to stinging criticism from the EP that the EC’s health council will meet in December to address both the short-term and structural problems with the MDR, but had little detail to offer other than a promise to keep the EP abreast of these developments.
The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds.
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.
Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, released its latest survey. This study analyses the availability of medical devices in 2022 in light of the Medical Devices Regulation (MDR) being implemented.
The EU’s Medical Device Coordination Group (MDCG) has advised the device industry that many manufacturers seem ill prepared for the transition to the Medical Device Regulation (MDR), which will be fully in force for all devices as of May 2024. MDCG said that that any leniency shown after that date will be granted only for devices that address an urgent public health need, potentially leaving many existing authorizations out in the cold.
The German Medical Technology Association, BVMed, and the French medical technology industries association, SNITEM, have issued a joint warning highlighting the risk of collapse in patient care throughout the EU.
Bringing a new medical device or diagnostic to market has never been a small feat for small companies, and regulatory review is still one of the largest hurdles facing device makers. However, a new report by Boston Consulting Group (BCG) and the UCLA Biodesign program shows that the twin issues of coverage and reimbursement still combine to present the most difficult hurdle to overcome for med-tech companies.
PARIS – The new European regulation on medical devices came into force on May 26, 2021, one year later than planned, due to the COVID-19 pandemic. This European medical device regulation (MDR) modifies the conformity assessment procedure for medical devices in the 27 countries of the European Union, repealing two council directives implemented in the early 1990s.
