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EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings

Industry holding out for IVDR delay but fears resurface over MDR bottlenecks in 2023-24

 
• By Ashley Yeo

Waiting until the grace period expires before making a product application under the EU MDR or IVDR is a gambit that could easily misfire, TEAM-NB warns.

Artur Szczybylo

The number of notified body audits to be completed before the EU Medical Device Regulation comes into effect has been a perennial concern of TEAM-NB and its notified body member companies.

But another issue threatens to supplant that: the number of audits that will need to be completed on products whose manufacturers have taken the grace period option, and used the...

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