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 categories are:
- Recreational and personal watercraft
- Simple Pressure Vessels
- EMC (meaning equipment in scope of 2014/30/EU)
- Non-automatic Weighing Instruments
- Measuring Instruments
- Radio Equipment
- Pressure Equipment
- Personal Protective Equipment
- Gas Appliances
- Outdoor Noise
- 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.
- There is a 12-month grace period for Class I devices.
- All manufacturers based outside the UK will need to establish a UK Responsible Person. Please be sure to read the description of responsibilities of a UK Responsible Person provided at the link.
- 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 if the product:
- is for the market in Great Britain, and
- is covered by legislation which requires the UKCA marking, and
- 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 recognized body before 1 January 2021. *Note that most UK bodies have opened offices in the EU.
We can be contacted via this link.
We can be reached by phone at 877-405-1580 and are here to help you.