New UK product regulation from 1st of January 2021

New UK product regulation from 1st of January 2021

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UKCA mark
UKCA mark
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Laws regulating product safety and performance are changing

CE marking is moving to UKCA marking in Great Britain. 

From 1/1/21, the UK will have new laws that regulate the safety and performance of certain products. From medical devices to machinery, electrical equipment to construction products, anyone looking to sell one of these products on the market in the UK will need to be aware of these changes.

Any product that has been sold in the UK with a CE marking on it, and anyone in the supply chain for those products, may be affected. The transition period following the UK’s departure from the EU ends on 1 January 2021.

After this point, the regulations that have required CE marking will change in the UK. There will be differing regulatory models for Great Britain (England, Scotland and Wales) and for Northern Ireland.

BSI statement regarding future UK/EU trade deal >

The new market structure

BSI will continue to be a crucial part of the UK market structure - supporting businesses, government and product users, including consumers and patients:

  • We continue to provide our services as the National Standards Body, bringing together expert stakeholders to deliver a national consensus on best practice for issues that span the UK economy and society.
  • We continue to perform our role as a trusted supplier of business services that support regulatory conformity through product certification and medical device and IVD conformity assessment.
  • BSI management systems (ISO) certification will still be recognized worldwide as it always has been.

This page will help you navigate to the part of the BSI website where you can find information you need on BSI support for the new regulatory model.

The regulatory framework is the responsibility of UK government and more information on regulations applicable to products placed on the market in the UK can be found here:

Department for Health and Social Care (for medical devices and IVD products) >
Ministry of Housing, Communities and Local Government (for construction products) >
Department for Business, Energy and Industrial Strategy (for other CE marking regulation) >

Support for new regulations

UKCA marking in Great Britain and in Northern Ireland and the EU from 1/1/21

UKCA is the new marking for placing relevant regulated products on the market in England, Scotland and Wales. It replaces the CE marking. There will be a period of continued recognition of CE marking in Great Britain (check individual regulations for full details on end dates).

Conformity assessment - UKCA

UK approved bodies will replace the role of EU notified bodies. Follow the links below to see how BSI can provide for UKCA marking-related services for a range of products:

Product certification

For construction products, PPE, gas appliances, boilers, pressure equipment, lifts, marine equipment, measuring instrument and radio equipment.

Medical devices and IVD

This covers all areas of medical device and IVD assessment as required by UK regulation.

Designated standards

Products manufactured to standards developed through BSI processes and designated by UK government will need to meet the requirements of the relevant UKCA marking legislation.

This system replaces the citation of harmonized standards by the European Commission under EU law. BSI will coordinate the development of British Standards that can be designated by UK government.

Learn more >

Conformity assessment - CE mark

Follow the links below to see the CE marking services BSI can offer via our Netherlands Notified Body (2797) for:

Product certification

For construction products, PPE, gas appliances, boilers, pressure equipment, lifts, marine equipment, measuring instrument and radio equipment

Medical devices and IVD

This covers all areas of medical device and IVD assessment as necessary under EU regulation, including EU regulation adopted in the UK for Northern Ireland.

Conformity assessment - CE marking plus UKNI marking

Where products are to be placed on the Northern Ireland market but not the EU market UK Notified Bodies will be able to offer CE marking services under UK law implementing EU directives.

These products will need to bear the CE marking and the UKNI marking together. The UK government advice on UK Notified Bodies is still being released and we will give more detail on BSI’s role in CE plus UKNI marking as soon as possible.

EU market access

Harmonized standards in the European Union and Northern Ireland

Products manufactured to harmonized European standards cited by the European Commission are presumed to conform to the requirements of relevant CE marking legislation in the EU and as adopted in the UK for Northern Ireland.

BSI will continue to coordinate the UK input into the development of harmonized European standards through CEN, CENELEC and ETSI.

Learn more >

Further information on BSI services: