Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?
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How TÜV SÜD Issues First Certificate Under EU’s IVD Regulation And Says Technical Documentation Is Key
Notified body TÜV SÜD has issued the first certificate under the EU’s IVD Regulation. The notified body has fundamental advice for manufacturers wanting to ensure their IVDs are compliant in time.
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.