The EU’s still-new regulations for medical devices and in vitro diagnostics are often seen as drivers of current or impending shortages of these products, but Oliver Eikenberg of regulatory consultancy Pure Global is unimpressed by such claims. Eikenberg said much of the drag on the EU system is engendered by device makers that are failing to get their regulatory affairs in order – a problem neither Brussels nor the notified bodies can fix.
The EU's regulatory crisis continues to roil relations between Brussels and stakeholders in the health care sector, and the European Parliament reacted with a message to the European Commission to revise the Medical Device Regulation.
The European Council formally approved another delay for the In Vitro Diagnostic Regulation
implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.
Reliance may be the regulatory buzzword of the moment, but mutual recognition agreements between regulators are much more near and dear to the hearts of device makers. Richard Phillips, director of strategy for Association of British Health Tech Industries Ltd., told an audience of device makers that the U.K. is considering recognition of devices approved and cleared by the FDA, although Phillips said such recognition for 510(k) devices might be less than a simple exercise.
The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle.
The European Commission (EC) has proposed another delay in the compliance deadlines for the In Vitro Diagnostic Regulation (IVDR) that eases the existing timelines by roughly two and a half years. The news was welcomed by Medtech Europe, which nonetheless pressed the EC and others to patch up some of the issues that led to the new extensions in the first place.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions.
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
