Call For Risk-Based Extension For Legacy Products And No Sell-Off Deadline Under EU MDR
Might the EU decide to go the way of the IVD Regulation with the Medical Device Regulation and allow devices certified under the former regime to remain on the market into the mid 2020s and beyond?
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There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.
Industry’s timely compliance with the EU’s new medtech regulations is under threat. Will the European Commission consider potential solutions from COCIR as a persuasive factor for change?
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.