Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued
The initial virtual audit ban is just one obstacle to timely EU MDR compliance. Another is that many companies have seriously underestimated how much time they need, even with the grace period.
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Almost half of companies polled on extra resources needed to comply with the EU Medical Device Regulation are preparing for considerable outlay. Manufacturers are also falling short in digital readiness.
The European Commission has published an Implementing Regulation explaining some of the fundamental practices that need to be carried out by different actors from the beginning for Eudamed to operate successfully.
Every new notified body designation under the Medical Device Regulation is being welcomed by medtech companies as the countdown continues for the grace period to end in May 2024.