UKCA Marking: Transition Period Extended
The requirement to replace the European CE-mark with the UK equivalent, the UKCA mark, came into effect on January 1 2021.
If you’ve yet to adjust your production processes to accommodate this change, panic not. The use of the CE-mark is still completely legitimate due to a “standstill period” that was to run to December 2022 and has now been extended to December 2024.
For medical devices, a different set of rules and dates apply with the upcoming Medical Device Regulations coming into force on July 1 2024.
This means that the standstill period has been extended by one year from June 30 2023. CE marked medical devices can stay on the British market until June 30 2024. After this date, transitional arrangements will apply.
These have yet to be set in stone, but it is likely that medical devices will need to be certified by a UK approved notified body.
The quality requirements are broadly the same for both CE and UKCA marked products. As such, the implementation of the UKCA mark is an administrative procedure that must be undertaken for products to remain on the UK market.
- The UKCA mark must be at least 5mm high unless legislation specifies different dimensions.
- The proportions of the letters must be retained according to the original mark.
- Marks must be directly applied to the product and be easily visible and legible.
- UKCA is a product marking for England, Scotland and Wales but is not recognised in the EU/EEA or Northern Ireland. These countries still require the CE-mark.
- Most medical products must be certified by a UK Approved Body though some Class 1 devices can be self-certified.
- Manufacturers from outside the UK must appoint a UK Responsible Person to register and act on their behalf.
- Both CE and UKCA marks can appear on the same product as long as both sets of regulations have been met.
Does UKCA replace UDI?
Both UKCA and UDI are independent standards and neither replaces the other.
The UKCA mark is a general product quality label while a UDI (Unique Device Identification) is specifically created for one individual medical device. Its purpose is to ensure traceability e.g. in case of a product recall and/or supply chain tracking or to simplify procurement and data processing, etc..
Regarding laser marking of medical devices, it is common to directly mark a UKCA/CE-mark with the laser whenever technically feasible. Direct marking of a UDI code is mandatory on products that are used and reprocessed multiple times, according to FDA and MDR regulations.
Our product partners, FOBA, are acknowledged experts in laser marking and provide a range of solutions to meet the unique challenges of the medical technology sector. For details and help in meeting your particular marking requirements, please contact email@example.com
Also see Laser Marking Machines