On 28 and 29 March 2023, the British and Swiss governments announced that the extension period in the manner set out in Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain Medical Devices and in vitro diagnostic Medical Devices will also apply in their territories, a measure that formalises and makes immediately enforceable in Europe the third transitional period for compliance with MDR (EU) 2017/745.
It will therefore be possible to place CE-marked Medical Devices in the UK and Switzerland within the deadlines set by Regulation (EU) 2023/607: until 31 December 2027 or until 31 December 2028, depending on the risk class and type of device.
Accordingly, the UK Ministry of Health (MHRA) has announced that the guideline Regulating Medical Devices in the UK will be updated to be adapted to this measure.
Similarly, Swissmedic plans a corresponding adaptation of the Ordinance on MDs (ODmed) of 1 July 2020 and the Ordinance on IVDs (ODIV) of 4 May 2022 for autumn 2023.
With these provisions, the Regulatory Authorities of the UK and Switzerland, like the European legislator, wished to avert a possible shortage of Medical Devices available on the market, allowing manufacturers based outside the territories more time to carry out all the necessary procedures to fulfil their regulatory obligations.
>> If you want to market Medical Devices in the UK and Switzerland, Thema can assist you with the Strategic Regulatory Consultancy Service, can be your UK Responsible Person (UKRP) and Swiss Authorised Representative (CH REP) and can support you in registering products with the Regulatory Authorities.
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