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Class I medical devices must be registered with the MHRA since January 1st, 2022.
Manufacturers of Class I medical devices must register if they sell, lease, lend or gift Class I devices they have manufactured, e.g. spectacle frames, ready-readers, finished and semi-finished lenses,…
If the manufacturer is based outside of the UK, they must appoint a UK Responsible Person who has a place of business in the UK.
UKRP Services will act on behalf of the manufacturer to assist with regulatory tasks under the manufacturer’s obligation in the United Kingdom.
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