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EU Medtech May Have Standards Certainty Days Before MDR Applies

 
• By Amanda Maxwell

The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last?

Standards text concept on green digital world map background

The EU medtech sector is likely to have more certainty over what is happening with standards needed in the context of the Medical Device and IVD Regulations shortly after 14 May, less than a couple of weeks before MDR fully applies on 26 May.

That is when the one-month deadline will be up for the European standards bodies, CEN and Cenelec, to accept the...

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