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Time To Comment On ‘Bold New Regulatory Regime’ For UK

 
• By Amanda Maxwell

Unconstrained by having to compromise with other countries’ regulatory approaches, the UK is now seeking views on its proposal for a pioneering and “bold new regulatory regime” for medtech products.

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The Medicines and Healthcare products Regulatory Agency has published its consultation document on the future regulation of medical devices and IVDs in the UK. Comments on the document will be accepted until 25 November 2021.

The new regime is scheduled to be in force at the beginning of July 2023, the date from which CE-marked...

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EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
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FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 
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Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

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