As a result of the EU Commission amendment on implementing extensions of the transition periods regarding the medical device regulation issued on the last 15 of March, the UK MHRA (Medicines and Healthcare Products Regulatory Agency) has also taken steps to provide manufacturers more time to get certified under the EU MDR.
Changes adopted by the EU Commission regarding extensions of the transition period for high-class devices as well as medium and low-risk devices and an extended validity of Certificates under MDD will apply automatically in Northern Ireland according to the Northern Ireland Protocol. Additionally, Certificates that are extended will also be recognized as valid for placing CE-marked devices in the UK market.
Currently, UK MHRA authorities have notified of an update in their registrations guidances to reflect this update.
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