Placing a medical device on the EU market

CE marking for the EU market:

The UKCA marking is not recognised on the EU market. To place a device on the EU market you must adhere to the relevant EU legislation and affix a CE mark to demonstrate compliance.

If you use a UK-based Notified Body to conduct any mandatory third-party conformity assessment for your device, the following will apply:

  • if your device was placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market
  • from 1 January 2021, you are not able to place a device on the EU market unless it has been assessed by an EU-recognised Notified Body

Conformity assessment:

The results of mandatory conformity assessment carried out by UK based conformity assessment bodies are not recognised by the EU. This is the case even if the assessment was carried out before 1 January 2021, unless your product had already been placed on the EU market before 1 January 2021.

Where allowed for under the relevant legislation, you can CE mark your medical device on the basis of self-certification for the purposes of the EU market.

Authorised Representatives:

Great Britain-based Authorised Representatives are no longer recognised in the EU. This means that they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market.

If you are a manufacturer based in Great Britain or another country outside the EU, you must appoint an Authorised Representative based in the EU or Northern Ireland if you wish to supply devices to the EU market.

Labelling requirements:

You must ensure that your device meets EU labelling requirements in order to place it on the EU market. Both the CE marking and UKCA marking can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Devices placed on the Northern Ireland market must meet EU labelling requirements.

Placing a medical device on the EU market:

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