UKCA mark and CE marking – September 2020 update from F2 Labs

We published an article about Brexit and its implications for CE marking back in February of this year. A link to that article is here. The UK government posted new guidance about this on September 1, 2020. The link to that information is here.

You do not need to go to those links and sift through the information. We have summarized the main points below.

  • CE marking will apply to most products until January 1, 2022. These product area categories are:
    • Toys
    • Recreational and personal watercraft
    • Simple Pressure Vessels
    • EMC
    • Non-automatic Weighing Instruments
    • Measuring Instruments
    • Lifts
    • Radio Equipment
    • Pressure Equipment
    • Personal Protective Equipment
    • Gas Appliances
    • Machinery
    • Outdoor Noise
    • Ecodesign
    • Aerosols
  • CE marking will apply to medical devices until June 30, 2023.
    • Note that beginning January 1, 2021 all medical devices and in vitro diagnostic medical devices imported into the UK must be registered with the Medicines & Healthcare Products Regulatory Agency.
    • There is a 4-month grace period for Class IIIs, Class IIb implantable products, and active implantable medical devices
    • There is an 8-month grace period for registering for Class IIb and Class IIa devices.
    • All manufacturers based outside the UK will need to establish a UK Responsible Person.
    • There is a 12-month grace period for Class I devices.
    • You can start using the UKCA mark (if your product complies) as soon as January 1, 2021 but if it is a medical device the CE marking will suffice until June 30, 2023.

You will need to apply the UKCA mark to your product beginning January 1, 2021 if all of the following apply to the product:

  • it is for the market in Great Britain, and
  • it is covered by legislation which requires the UKCA marking, and
  • it requires mandatory third-party conformity assessment, and
  • conformity assessment has been carried out by a UK conformity assessment body and you haven’t transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021. *Note that most UK bodies have opened offices in the EU.

The above means that if your product is a medical device you will need to register it in the UK at the end of this year or sometime in 2021 based on device category. You will also need a UK Responsible Person. Regarding other product categories you have some time (another year) as long as your product does not meet all four bulleted points immediately above.

We can be contacted via this link

We can be reached by phone at 877-405-1580 and are here to help you. 

F2 Labs is here to help.

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