MDR/IVDR proposal for simplication
12 hours ago the European Commission published THE MOST AWAITED AND CRUCIAL DEVELOPMENT IN A DECADE: its proposal for simplification of the MDR and IVDR. 👏
Alert: it is still only a proposal, albeit official, which has been submitted to the European Parliament and the Council, but will need to go through the ordinary legislative procedure to become binding Union law.
From a first diagonal read, what struck my attention:
🎉 More room for Class I devices, incl software (THANK YOU!)
🎉 Simplified interaction with AI Act
🎉 Codified instruments for open dialogue on classification and access to expert panels
🎉 Easier "equivalence" concept including use of synthetic data,
🎉 Lower NB fee structure for SMEs
🎉 Extended reporting timelines and validity of certificates
🎉 Reduced scope of surveillance audits and conformity assessment
🎉 Built-in flexibility for public health emergencies, breakthrough/orphan devices (i.e. life-threatening, rare, untreated diseases), supply-chain disruptions
Interestingly, but unsurprisingly, it proposes additional requirements for cybersecurity conformity and reporting (beyond what qualifies as medically "serious").
I will share more details of how this would impact specifically medical device startups especially in digital health and femtech.
While it is still ONLY A PROPOSAL, it is sign that EU is listening and actively working to "make [the current rules] easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety in this key sector"
We're excited to follow the development of the legislative decision-making process and wait eagerly for the change of an era this (or its variants that will result) will bring to the European medtech sector!
