This sheet is particularly useful for the 'Requirements' Worksheet and the links below can be used to help search online databases for relevant UK regulations, codes & standards and approved bodies.
UK Government guidance with a list of "designated standards" that provide presumption of conformity with GB law. After 1st January 2021, all EU harmonised standards that give a presumption of conformity to EU law became 'designated standards' by the references published on this GOV.UK website.
BSI provides a searchable catalogue of British standards for a vast range of equipment devices and services. This can be searched using keywords or by sector/subject. Many standards are identical to ISO equivalents, e.g. BS EN ISO 9001.
The UKCA marking is the new product marking introduced after 1st January 2021 to be used for goods within the GB market (England, Wales & Scotland). It covers most goods previously covered by the CE marking. This GOV.UK website provides the latest guidance.
BSI services include company certification (e.g. 9001) auditing/verification, product testing/certification, consulting/advice and training. Free webinars are also available.
UK Government provided list of approved UK market conformity assessment bodies, who have been accredited by UKAS to assess conformity of products and services to UK designated standards. This can be searched using keywords, by product or by legislative area (technology sector). These effectively replace the EU's NANDO notified bodies database for the UK.
UKAS, the UK's national accreditation body, is the only organisation able to grant accreditation of UK based conformity assessment bodies. The UKAS website provides a searchable list of UKAS organisations who can provide conformity assessment including testing, inspection and certification of products, devices, processes and people, across a wide range of industry sectors. When searching for accredited laboratories, look for the national accreditation symbol, denoting testing facilities compliant with ISO 17205. All organisations accredited to ISO 17205 for testing are required to list their accredited activities on the UKAS website. See the Testing and Analysis Help Sheet for more info.
The UKCA marking cannot be used for goods placed on the Northern Ireland market. For goods placed on the market since 1st January 2021, the Northern Ireland Protocol requires Northern Ireland to align with relevant EU rules relating to the placing on the market of manufactured goods. This GOV.UK website provides the latest guidance on using the UKNI and CE Marking in Northern Ireland.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This GOV.UK website provides details on GB, NI and EU requirements for medical devices links to lists of relevant approved bodies for medical devices in each jurisdiction as well as the use of CE and UKCA marking.
The UK left the EU on 1 January 2021 and the agreed transition period ended 31 December 2021, as such the requirements for placing some
products on the UK and EU markets (including the arrangements for conformity assessments, marking and labelling) have changed slightly
and may continue to change further into the future. UK Based Notified Bodies have become approved UK Market Conformity Assessment Bodies
for the UKCA mark, which replaces the CE mark of the EU.
The UKCA (UK Conformity Assessed) marking is the new product marking which must be used to demonstrate that certain goods are compliant
with the new UK rules. This new product marking that demonstrates that certain goods are compliant with UK regulations and is used when
these goods are placed on the market in Great Britain. It covers all goods which previously required the CE marking and aerosol containers
(which previously required the reverse epsilon marking). It does not apply to existing stock, such as goods which were fully manufactured,
CE marked and placed on the market before 1 January 2021 (BRC).
