CE marking and Notified Bodies

CE marking:

We will continue to accept CE marked devices on the Great Britain market until 30 June 2023. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:

  • Directive 90/385/EEC on active implantable medical devices (EU AIMDD) (for devices that have been CE marked prior to 26 May 2021)
  • Directive 93/42/EEC on medical devices (EU MDD) (for devices that have been CE marked prior to 26 May 2021)
  • Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) (for devices that have been CE marked prior to 26 May 2022)
  • Regulation 2017/745 on medical devices (EU MDR)
  • Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)

From 1 July 2023, devices that are placed on the Great Britain market will need to conform with UKCA marking requirements.

In cases where you self-certify for the CE marking, you will be able to continue to do so and place your device on the Great Britain market until 30 June 2023. Please note that you will need to meet EU MDR requirements for CE marking Class I devices that you self-certify from 26 May 2021. Similarly, you will need to meet IVDR requirements for CE marking if you self-certify general IVDs from 26 May 2022.

Relevant devices that have been self-certified against the CE marking prior to these dates may continue to be placed on the Great Britain market providing their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.

For other product areas covered by the UKCA marking, a UKCA marking will be required earlier than 1 July 2023. For example, certain product areas will require a UKCA marking from 1 January 2023.

Where medical devices are subject to the requirements of any of the medical devices legislation cited above and, in order to be CE marked, must also meet the relevant requirements of another piece of EU legislation (such as the Directive restricting the use of certain hazardous substances), they can remain on the Great Britain market carrying a CE mark until 30 June 2023 - irrespective of whether the UK legislation governing the subject matter of that other piece of EU legislation would require a product to have a UKCA marking before 30 June 2023. In order to maintain the use of the CE marking for a medical device in Great Britain, the manufacturer will need to meet all relevant EU legislation that governs their device.

EU Notified Bodies:

Any mandatory third-party conformity assessment for the CE marking must be carried out by an EU Notified Body. This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System.

Certificates issued by EU-recognised Notified Bodies that are valid for the EU market, will continue to be valid for the Great Britain market until 30 June 2023.

Recognition of existing CE certificates for the Great Britain market:

Under the UK MDR 2002, a CE marked device with a valid declaration of conformity or certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - until 30 June 2023. This includes devices placed on the market that are:

  • CE marked in accordance with the EU MDD or EU AIMDD (prior to 26 May 2021), or EU IVDD (prior to 26 May 2022)
  • CE marked in accordance with the EU MDR or EU IVDR

Therefore, any enforcement or market surveillance powers available in respect of the UKCA marking also apply to CE marked devices placed on the Great Britain market.

Where certificates have been issued by a UK Notified Body and those certificates have not been transferred to an EU Notified Body, the UK Notified Body has been re-designated as a UK Approved Body and will continue to oversee these devices and their manufacturers to ensure continued compliance with the applicable standards of safety and performance under the UKCA marking.


CE marking and Notified Bodies:

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