Harmonization Of The EU Regulatory Compliance Role: Many PRRC Issues To Be Clarified
Efforts are underway to create a harmonized approach among Persons Responsible for Regulatory Compliance who play a pivotal role in meeting the requirements of the EU MDR and IVDR. And liability issues are high on the agenda.
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No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.