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Biggest medical device markets in Europe with its own regulation

UK

UK Conformity Assessed – UKCA Marking

1st January 2021, the UK government implemented its own UK Conformity Assessed – UKCA marking scheme for medical devices to be placed in the Great Britain (England, Scotland & Wales) market following the exit of United Kingdom (UK) from European Union (EU).

The currently CE certified medical devices can be continued to be sold in the UK till June 30, 2023, after which the manufacturers would be required to comply with the requirements of the new UKCA marking regulation to continue to place their devices in UK.

Similar to the CE marking followed for EU, medical devices require a third party assessment process by a UK Approved body to obtain an UKCA marking. EU Notified Bodies can perform conformity assessment for CE- marking according to their designation, but cannot issue UKCA marking.

The prevailing UK Notified Bodies will roll over to become UK Approved Bodies for UKCA marking, but have lost their label as EU Notified Bodies for CE-marking. However, the UKCA-marking that will become the mandatory route to market in Great Britain will not be accepted in Northern Ireland: Northern Ireland will continue to identify CE-marking. This means that UK manufacturers placing product on the entire UK market will require both CE-marking and UKCA marking.

At Maven, we are available to help customers transit and keep up with these evolving requirements. This means providing updates on the requirements and also working on the establishment of a robust UK Conformity Assessed (UKCA) conformity assessment process that minimizes duplication of activities and disruption.

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