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Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave

 
• By Amanda Maxwell

The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”

Hand flip wooden cube with the word PLAN A to PLAN B on white background. Business concept

The European Commission is now preparing to issue a standardization request to the European standards organizations, CEN and Cenelec.

This follows a positive opinion among member states within the commission’s Committee on Standards on 12

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More from Geography

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
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Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

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