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.
With less than three months to go until the full application of the EU’s Medical Device Regulation, industry is trying to put its foot on the accelerator, but is finding the brakes are on.
There are very few regulatory hurdles to placing a COVID-19 test on the EU market under the IVD Directive. This situation, however, is changing under the IVD Regulation. The European Commission explains what manufacturers need to weigh up when deciding their regulatory pathway.