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BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

 
• By Amanda Maxwell

There is not much demand currently for testing against the EU's Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

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Despite being designated under the MDR in January this year, BSI, one of Europe’s largest medtech notified bodies, has only issued one certificate under the MDR so far. It does not expect to issue more than ten by the year end.

The vast majority of EU medtech companies are instead seeking renewal under the current medical device directives, Gary Slack, senior...

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More from Europe

EU Digital Omnibus Meets MDR And IVDR Revisions: Alignment Or Chaos?

 
• By Amanda Maxwell

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Long-Awaited EUDAMED Notice Ushers In New Era Of Compliance

 
• By Amanda Maxwell

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Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution

 
• By Amanda Maxwell

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.

More from Geography

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What Exact-ly Is In Store For Liquid Biopsy?

 
• By Barnaby Pickering

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LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

 
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A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.