Starting from 1 July 2024, a UK Conformity Assessment (UKCA) certification will be required by all manufacturers that want to place their medical devices or in vitro diagnostics in the Great Britain (GB; England, Wales and Scotland) market (UK MDR SI 2002 No. 618, Part II, Section 10).
*1 year extension announced by MHRA
For manufacturers holding CE certificates under Directive 90/385/EEC and 93/42/EEC that are eligible for extension under the Regulation (EU) 2023/607, the updated timelines will also apply for the GB market. (More information are available from MHRA, Extension of CE certificates – GOV.UK (www.gov.uk))
Starting from 1 July 2024, all manufacturers must hold a UKCA certificate to market their products in GB. To get certified, the product(s) shall conform to the requirements of the UK Medical Devices Regulation 2002 (SI 2002 No 618, as amended), as assessed by a UK Approved Body for UKCA.
UKCA marking requirements are based on the requirements of the following EU Directives:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
IMPORTANT:
For manufacturers outside GB with products holding a UKCA certificate, the UKRP information should be included in the device labelling.
Northern Ireland
Northern Ireland has a different legislation, distinct from GB (England, Wales and Scotland). For manufacturers wishing to enter the Northern Ireland market, a CE marking is required.
To place a CE marking on medical device for circulation in both Northern Ireland and the EU, an EU-recognised Notified Body is required to undertake any mandatory third-party conformity assessment.
UK Approved Bodies (referred only in this case as “UK Notified Bodies”) can apply to be designated under the relevant EU legislation for the purposes of conducting conformity assessments for the Northern Ireland market. When a UK Notified Body undertakes the conformity assessment, the manufacturer will also need to apply the UKNI indication (alternatively, UK(NI) mark or UK(NI) marking).
We are here to assist
Need more details?
Phone Number
020 3386 9549
Email Address
info@evnia-ar.com
Website
https://www.evnia-ukrp.co.uk
Address
1 Canada Square, 37th Floor, London, E145AA
