We must alleviate the bureaucratic burden
Supply bottlenecks (such as those we’ve seen throughout the pandemic) are part of why many clinics across Europe find themselves short-stocked on critical medical equipment.
However, the high bureaucratic and cost hurdles of obtaining and maintaining approval for medical devices through the EU Medical Devices Regulation (MDR) process are also to blame.
In August, the German Medical Device Coordination Group (MDCG) published a paper proposing measures to mitigate many of these MDR challenges. The German Medical Technology Association (BVMed) has officially expressed its support for these proposals.
One of the biggest action items highlighted in these conversations is the importance of creating pragmatic approaches to moving existing MedTech products through the MDR process with the lowest bureaucratic burden. As it stands, the relevant bureaucratic bodies already have limited capacity with the QMS audits and technical documentation reviews.
Concrete steps to ameliorate some of these bureaucratic bottlenecks include:
- Issuing conditional certificates
- Recognizing the similarity principle
- Streamlining the consultation process
- Suspending scope extension audits
These conversations are essential to ensuring a high level of patient care across the EU. We cannot let unnecessary administrative work and prohibitive costs keep life-saving therapeutics from the clinicians and patients who desperately need them.
Ideally, we also need the actions to be implemented quickly. Discussions and publications are wonderful first steps, but the MedTech ecosystem and the people it serves need solutions today.
I’m curious: What are your thoughts on these proposals? How do you think our industry can be more forward-thinking in this area?
