Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued
Executive Summary
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.
You may also be interested in...
EU MDR Compliance Will Cost More Than 5% Of Revenues For Half Of Medtechs, Survey Says
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.
European Regulatory Roundup, January/February 2021: Virtual Audit Issue Frustrates MDR Progress
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.
COVID-19 Tests: How The EU Rules Are Changing And Where Questions Still Lie
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: