UK unilateral recognition of CE mark has been saved
UK unilateral recognition of CE mark
Legal and regulation
Brexit pulse alert: respond to the business impacts of Brexit
2 September, 2020
The UK government has announced it will unilaterally accept products onto the UK
market that carry a CE mark until 31 December 2021. This covers goods regulated
under the ‘new approach’ but not those under the old approach. These will be covered by different guidance, see for example the published updated guidance Medicines and Healthcare products Regulatory Agency (MHRA).
Top Brexit impacts
- Businesses can continue to use the CE marking until 31 December 2021 if:
- you currently apply the CE marking to your goods on the basis of self-declaration
- any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (including a body in a country with which the EU has a relevant mutual recognition agreement)
- the certificate of conformity previously held by a UK-approved body has been transferred to an EU-recognised notified body
- The UKCA will not be valid in Northern Ireland (NI). Products sold in NI will be required to carry the CE mark.
Actions for business
- You will not need to do anything if you currently self-certify a CE mark and wish to continue doing so.
- Similarly, if you use an EU-notified body for a conformity assessment, that can continue as now until the end of 2021.
- If you are using a UK-notified body you will either need to switch to using a UKCA mark for Great Britain and a CE mark for EU and NI. Or shift to using an EU-notified body for all. The actual testing a requirements for a UKCA mark and a CE mark will be the same at the start of 2021. These may diverge over time but not before the end of 2021.
To discuss specific support with your Brexit preparations based on this latest development contact: Deloitte Brexit Insight