Ready for UKCA? New deadlines!
Following Brexit, products that currently bear a CE mark require a new UKCA (UK Conformity Assessed) mark to remain or be introduced on the UK market. Read here what has to be considered for the product labeling of medical devices and which deadlines currently apply for the implementation of UKCA marking.
Which deadlines apply for the introduction of the new UKCA standards?
The new UKCA regulation came into effect on January 1, 2021. For goods in general, the use of the CE-mark is still possible during a "standstill period" until December 31, 2024. (This extension of the standstill period from initially December 2022 was announced in October 2022.)
Different rules apply for medical devices:
The future Medical Device Regulations shall be brought into force on July 1, 2025. (The respective standstill period has thus been extended twice by one year each: in October 2022 and on April 27, 2023 from initially June 30, 2023.)
Already CE-marked medical devices may therefore remain on the British market until June 30, 2025. From July 1, 2025, transitional arrangements for medical devices will apply for the use of CE- and UKCA-certification.
As a result, this also implies that medical devices need to get certified by a UK approved notified body. The quality requirements appear to be mainly the same for both CE and UKCA. Therefore, the implementation of the UKCA is an administrative procedure to go through in order to remain on or enter the UK market.
Which countries require UKCA?
UKCA is a Great Britain product marking standard, valid for England, Wales and Scotland.
UKCA is not recognized in the EU/EEA or Northern Ireland. These countries still require CE marking.
Who is responsible for issuing UKCA certification?
Some class I devices can be self-certified. Most medical products must be certified by a UK Approved Body. Manufacturers from outside UK must appoint a UK Responsible Person to register and act on their behalf.
What's the required size of the UKCA mark?
The mark must be at least 5 mm high – unless relevant legislation specifies different dimensions.
The proportions of the letters must be kept according to the original mark.
Can products bear both CE and UKCA?
Yes, it is possible to have both marks on one product, as long as they fulfil both CE and UKCA regulations. Wherever possible, marks must be applied directly on the product. They must also be easily visible and legible.
UKCA and UDI: Does UKCA replace UDI in the UK?
No, both are independent standards.
Whereas the UKCA mark is a general product quality label, a UDI (Unique Device Identification) is specifically created for one single medical device. The UDI purpose is to ensure traceability, e. g. in case of product recalls, for supply chain tracking, to simplify procurement and data processing etc.
The UDI system is intended to provide globally harmonized device identification and coding in the medical technolgy. However, in the UK it is still voluntary to submit a UDI at the point of registration of a medical device with the British MHRA (Medicines and Healthcare products Regulatory Agency). Currently, the authorities are still in the process of discussing to which extent the UDI system should be implemented in the UK.
Regarding the direct part laser marking of medical devices, it is common to mark a UKCA / CE mark whenever technically feasible. The direct marking of a UDI code, on the other hand, is mandatory on products that are used and reprocessed multiple times, according to the FDA and MDR regulations.
Even if UDI is not (yet) mandatory in the UK, many manufacturers have already obtained UDIs for their medical devices, especially if they want to allocate them on international markets.
We provide you with some links to recent information by the British government regarding the UKCA regulations:
- Guidance for UKCA implementation
Using the UKCA marking
(including a list of all updates)
- Extension of standstill period for medical devices until July 2025
Implementation of the future regulation of medical devices and extension of standstill period
- Registration and UDI of medical devices in the United Kingdom
Registration and UDI