Medical Devices, Brexit and the UKCA

Medical Devices, Brexit and the UKCA

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.
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Medical Devices, Brexit and the UKCA
Medical Devices, Brexit and the UKCA
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Labelling transition from the UK (0086) to NL (2797) BSI Notified Bodies

Due to the ongoing Brexit trade negotiations and the unpredictable outcomes, there is an increased risk that products, including medical devices and IVDs labelled with a UK notified body number might face challenges in clearance at the EU border customs after 01 January 2021.

This communication is critical for you if you migrated your CE certificates from BSI UK (0086) to BSI NL (2797), and you are currently completing your labelling transitions, and there is any possibility of a delay to your strategy, which means that you may not complete all labelling transitions by December 2020. We understand that COVID-19 may have negatively impacted your preparations, or you are planning to complete your labelling transitions in 2021.

Impact and actions for your products

At the time of certificate migration, the majority of which were completed in early 2019, BSI allowed up to two years for labelling transitions, based on traceability of information between its UK and NL Notified Bodies. This was agreed upon with our regulators and designed to allow you enough time to transition your products labelling.

EU guidance on industrial products, which covers medical devices and IVDs, indicates that manufacturers will have to adapt their product labelling, where necessary, by 1 January 2021. To mitigate the increased risk of your products not being cleared at the EU borders, BSI strongly recommends that manufacturers consider completing their labelling transitions by the end of this year.

ISO 13485 after brexit

ISO 13485 after brexit

Read the news article to learn more about the validity of accredited management system certificates issued by UK based conformity assessment bodies following the UK's departure from the EU.

Read the article

Requirement to appoint EU Authorized Representative

For GB based manufacturers

As you are aware, the UK will leave the European Union, often referred to as Brexit, on the 31 December 2020.

The outcome of Brexit negotiations has not yet been determined which means there are currently no agreed post-Brexit transitional arrangements.

Please be reminded that unless the outcome of Brexit negotiations makes specific provision for EU Representatives, it will become a legal requirement from the 01 January 2021 that manufacturers who are based in Great Britain (GB) and hold CE certification from an EU Notified Body such as BSI NL (2797) to have an Authorised Representative based in EU. 

Approval of the Authorised Representative is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of representative labels, Information for Users, the draft Declaration of Conformity, and the contract between the manufacturer and the EU Authorised Representative. 

With only limited time remaining until Brexit, you are strongly encouraged to consider making provision for an Authorised Representative for continued access to the European market if you have not already done so.

Should you wish to request approval of an Authorised Representative, please complete the change request form (MDF4900) and return it to your BSI Scheme Manager.

For manufacturers with GB based EU representatives

As you are aware, the UK will leave the European Union, often referred to as Brexit, on the 31 December 2020.

The outcome of Brexit negotiations has not yet been determined, which means there are currently no agreed post-Brexit transitional arrangements.

Manufacturers located outside of the European Union are required to appoint an authorised representative, who must be established in the European Community and is explicitly designated to act and be addressed by authorities and bodies in the European Community with regard to the manufacturer’s obligations under the directive.

Please be reminded that unless the outcome of Brexit negotiations makes specific provision, Authorised Representatives located in Great Britain (GB) will cease to fulfil the definition of Authorised Representative following the UK’s exit from the European Union on the 31 December 2020.

With only limited time remaining until Brexit, you are strongly encouraged to review your provisions for an Authorised Representative in the European Community for continued access to the European market if you have not already done so.

Approval of the Authorised Representative is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of representative labels, Information for Users, thedraft Declaration of Conformity, and the contract between the manufacturer and the EU Authorised Representative. 

Should you wish to request approval of an Authorised Representative, please complete the MDF4900 change request form (MDF4900) and return it to your BSI Scheme Manager.

Can I apply for UKCA now for Medical Devices and IVDs?

When can we apply for UKCA certification?

  • After 01 January 2021

Will BSI UK be ready to accept UKCA applications from 01 January 2021?

  • Depends on when the UK legislation will be finalised and the time it allows BSI to prepare
  • Further communications planned

We have a CE certificate (Directives or Regulations) issued by BSI NL (2797). Can we get a UKCA certificate based on the CE certificate?

  • Yes, a formal application will be required
  • In the short term while UKCA is based on Directives: No additional conformity assessments (To be confirmed)
  • In the long term when new regulatory frame-work is in effect – To be determined

We have a CE certificate (Directives or Regulations) issued by another EU NB. Can we get a UKCA certificate from BSI based on the CE certificate?

  •  Yes, a formal application will be required
  • In the short term when UKCA is based on Directives: Some level of conformity assessments will be required. (To be confirmed)
  • In the long term when new regulatory framework is in effect – To be determined

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