UKCA MARK REPLACES THE CE MARK IN THE UNITED KINGDOM

October 3, 2022

Submitted by: By: Yvonne Halpaus, QNET LLC – USA – CE consulting

Since BREXIT went into effect, the UK requires a UKCA mark to replace the CE Mark effective December 31, 2022. The UK consists of: England, Wales and Scotland. It excludes Northern Ireland, which requires a UKNI Mark.

The Manufacturers’ Declaration of Conformity needs to reflect the new UK terminology, for example:

  • Machinery Directive 2006/42/EC is now Supply of Machinery (Safety) Regulations 2008
  • Low Voltage Directive 2014/35 is now Electrical Equipment (Safety) Regulation
  • Electromagnetic Compatibility (EMC) Directive is now Electromagnetic Compatibility Regulation 2016
  • Harmonized Standards are referred to as designated standards

Other changes include:

  • EU authorized representatives are no longer acceptable in the UK, and manufacturers now need an additional agreement with a UK authorized representative. UK authorized representatives are not acceptable for the EU countries. This change went into effect January 1, 2021.
  • Notified Bodies are referred to as UK Conformity Assessment Bodies or UK CAB. EU Notified Body Certificates are no longer acceptable in the UK effective December 31, 2022, and manufacturers will now need a new certificate issued by a UK CAB. A UK CAB certificate is not acceptable in the EU.
  • Medical devices have additional requirements, such as a separate registration in the UK by their UK authorized representative.

Please check the following websites for more information:
For medical devices: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
For machinery: https://www.hse.gov.uk/work-equipment-machinery/uk-market.pdf

Switzerland
Switzerland discontinued part of their mutual agreement with the EU that pertains to medical devices only. It requires that a medical device manufacturer contracts with a Swiss authorized representative. EU or UK authorized Representatives are no longer accepted for medical devices only.

<<<--Return to Fall 2022 International Update

;