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BioWorld - Tuesday, April 7, 2026
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Home » European Commission proposes new extension of MDR timelines with conditions
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European Commission proposes new extension of MDR timelines with conditions

Jan. 9, 2023
By Mark McCarty
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications.
Medical technology Regulatory Europe

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