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MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date

 
• By Amanda Maxwell

A new reference in the document reminds the medtech sector that EU harmonized standards remain voluntary to encourage innovation.

Standards_Process

The Medical Device Coordination Group has endorsed MDCG 2021-5 Rev. 1, a first revision of its now 27-page guidance on standardization for medical devices for use in the context of the EU’s Medical Device and IVD Regulations.

The updated document has been welcomed by experts in the industry for the way it reflects recent developments in the...

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Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 
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A Passport To Streamlined Medtech Access Under UK Life Sciences Plan

 
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