The European Council applied its seal of approval to a proposal to extend the deadlines for the Medical Device Regulation (MDR), providing industry some critical breathing room to obtain certification for devices brought to market under the legacy Medical Device Directive (MDD).
The European Parliament (EP) has voted to affirm the proposal by the European Commission (EC) to extend the compliance timelines for the Medical Device Regulation (MDR) in an urgent vote that eliminated any chance of debate. The vote was a landslide, coming in at 564 votes in support and three nays.
The Medical Device Manufacturers Association (MDMA) has led the policy charge for smaller medical device manufacturers for decades, but each year brings its own unique set of hazards and opportunities. In an interview with BioWorld, MDMA President and CEO Mark Leahey said that while the Medicare policy for coverage of breakthrough devices has gone through some unanticipated twists and turns, that policy is not yet fixed and thus there is still some prospect that such a policy will not devolve into a stew of leftovers drawn from existing coverage mechanisms.
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications.
The European Union’s (EU) Artificial Intelligence Act (AI Act) drew a fair amount of criticism when it was first released, but Team-NB, the association of notified bodies (NBs) for the EU, has weighed in with some less than flattering observations. The group’s position paper on the legislation said that the act would not only up-classify some artificial intelligence algorithms to a higher risk class but would also resurrect the backlog of applications because of burdensome new requirements for NBs, thus exacerbating an existing crisis of med tech availability in the EU.
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.
The European Commission has given in to the increasing pressure and alarm from member states and is moving to extend the deadlines for implementing the 2017 Medical Device Regulation (MDR) and the In Vitro Devices Regulation (IVDR).
Switzerland is making moves to allow the import of U.S. FDA-approved medical devices after losing barrier-free access to the EU market and over rising concerns about the dismal pace of implementation of the EU’s upgraded devices regulations.
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 U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.