MHRA elaborates on new EU regulations for medical devices and IVDRs

Recommendation

7/8 May 2024

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Despite Brexit, the British "Medicines and Healthcare products Regulatory Agency" (MHRA) informs about new EU regulations for medical devices.

The MHRA has launched their own website on EU regulations for medical devices and in vitro diagnostic medical devices (IVDR). A special highlight is the 27-page summary of the extensive EU regulation which consists of several hundred pages.

After the introduction (with a diagram on transitional periods), the guide contains

• Definitions,
• Classification (medical devices: I IIa/b, III and IVDRs: A-D),
• Conformity assessment,
• Placing a Device on the market,
• UDI and Eudamed,
• Supply chain obligations,
• PMS and vigilance,
• Contact addresses.

Therefore, the website Medical devices: EU regulations for MDR and IVDR is a great source for whoever wants a quick overview of the new EU regulations for medical devices and IVDRs.

The website also provides up-to-date information on the Brexit, which describes the intended procedure for medical devices, amongst other things.