The Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a statutory instrument before June 30, 2023, which will accept that CE marked medical devices be placed on the Great Britain market according to the following:
- General MDs compliant with the EU MDD or EU AIMDD with a valid declaration and CE marking can be placed on the Great Britain market up until June 30, 2028 or the certificate expiry date, whichever comes first;
- IVDs compliant with the EU IVDD can be placed on the Great Britain market up until certificate expiry date or June 30, 2030, whichever comes first; and
- General MDs, including custom-made devices, compliant with EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until June 30, 2030.
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