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Transitioning from EU Notified Body certificates

Regulatory basis

See the official sources listed in the references table at the bottom of this page.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice.

Overview​

How manufacturers with EU Notified Body certificates transition to UK Approved Body certification for the GB market — legacy certificate acceptance, 2030 deadline planning, and the practical steps for UKCA transition.

The current position: CE transitional acceptance​

Until 30 June 2030, CE-marked devices may be placed on the GB market without UKCA marking. This means manufacturers with current EU Notified Body certificates for their devices can continue to supply the GB market under CE marking during this period.

See CE marking — transitional acceptance in GB for the full transitional position.

When will UKCA marking be needed?​

From 1 July 2030, UKCA marking will be required for devices placed on the GB market. Manufacturers relying solely on CE marking for GB access must obtain UKCA marking before this date.

Steps to transition to a UKAB​

  1. Select a UKAB — identify a UKAB designated for your device type and conformity assessment route (see Finding a UKAB)
  2. Engage early — UKAB capacity is limited; demand will surge as 2030 approaches. Begin engagement well in advance (aim for 2–3 years before your target UKCA date)
  3. Gap analysis — assess your technical file and QMS against UK MDR 2002 Essential Requirements; most EU MDR-compliant technical files will broadly satisfy UK ERs, but differences exist
  4. Apply to the UKAB — submit formal application and documentation
  5. Complete the audit and assessment — address any non-conformities
  6. Obtain UKAB certificate — issue UK Declaration of Conformity; affix UKCA mark
  7. Update MHRA registration — update certificate reference in MHRA Submissions portal

Can the same certificate cover both EU and GB?​

No. EU Notified Body certificates are valid for the EU and Northern Ireland markets only. UK Approved Body certificates are valid for the GB market only. Manufacturers serving both markets need both an EU Notified Body certificate (for EU + NI) and a UKAB certificate (for GB).

Legacy EU MDD / AIMDD / IVDD certificates​

Devices that were certified under the legacy EU directives (MDD, AIMDD, IVDD) before EU MDR/IVDR applied — and that are relying on those certificates via EU MDR/IVDR transitional provisions — may continue to be supplied in GB under CE marking during the transition period. However, once EU MDR/IVDR transitional provisions expire for those devices in the EU, the CE marking basis changes, and manufacturers should verify that their GB CE marking reliance remains valid.

Official references​

ReferenceDescription
DHSC: UKCA marking announcement (June 2023)CE marking accepted in GB until 30 June 2030
MHRA: UK Approved BodiesUKAB designation list
UK MDR 2002, Schedule 3UKCA conformity assessment procedures