December 22, 2020
In light of the most recent updates around Brexit, the U.K. and the European Union have come to an overall trading agreement. Beginning Jan. 2021, the U.K. no longer benefits from customs union arrangements between EU members. As such, the U.K. government will take on the responsibilities for the U.K. market, currently undertaken through the EU system. Based on this preamble, the U.K. Conformity Assessed (UKCA) marking is the new product safety marking that will be used for most goods being placed on the market in Great Britain, consisting of England, Wales and Scotland. We spoke with Maurizio La Mura, an engineer at UL focused on CE Marking as well as QMS certification programs, to get some answers.
How does the UKCA mark impact the medical and in vitro diagnostic devices placed in the Great Britain market?
For manufacturers willing to sell their devices in England, Wales and Scotland, I would group the impact of the UKCA marking into three main categories:
- Certificates validity
- Interaction with the Medicines and Healthcare products Regulatory Agency (MHRA)
- Changes to labels
How long will certificates remain valid?
The good news is, in terms of certificates validity, CE marking will continue to be recognized in Great Britain until June 30, 2023, — either under Active Implantable Medical Device Directive (AIMD)
/Medical Device Directive (MDD)/In Vitro Diagnostic Directive (IVDD) and Medical Device Regulation (MDR )/In Vitro Diagnostic Regulation (IVDR) — although a UKCA product marking route will be available for manufacturers wishing to apply it already from Jan. 1, 2021. After June 30, 2023, however, all devices entering the British market will need to be certified through the UKCA marking process.
At the moment, UKCA marking will be based on the U.K. Medical Devices Regulations 2002 in the form in which they exist on Jan. 1, 2021 built on the European Directives (AIMD, MDD and IVDD). This means that the UKCA marking requirements will continue to be based on the requirements derived from current EU legislation.
What about the interaction with the MHRA?
Although from Jan. 1, 2021, all medical devices placed on the U.K. market, including Northern Ireland, will need to be registered with the MHRA, a grace period for registering will span from May 1, 2021, for Class IIIs and Class IIb implantables and all active implantable medical devices and in vitro diagnostic (IVD) List A products, to Sept. 1, 2021, for other Class IIb and all Class IIa devices and IVD List B products and self-test IVDs, and ending on Jan. 1, 2022, for Class I devices, custom-made devices and general IVDs (that do not currently need to be registered).
Nevertheless, manufacturers based outside of Great Britain will feel a bit of pressure. From Jan. 1, 2021, manufacturers based outside the U.K. and wishing to place a device on the Great Britain market will need to appoint a single U.K. responsible person (UKRP). who will take responsibility for the product in the U.K. The MHRA recommends appointing a UKRP as soon as possible, and my suggestion is to carefully consider all possible options before appointing a UKRP. This is because their responsibilities will not only be about device registration but also to cooperate with the MHRA in case of corrective actions or vigilance issues for the devices under their responsibility and to ensure a Declaration of Conformity and Design Dossier are in place, meet UKCA marking requirements and are available upon request.
Based on this, I would recommend the selection of a UKRP with proven experience and recognized regulatory background and knowledge, although MHRA guidelines suggest that importers based in the U.K. could also act as a UKRP, provided they have the rights to do so.
What is the the impact on labeling?
Some good considerations on this aspect as well, which clearly shows the MHRA’s flexibility and desire to smooth the transition as much as possible for the manufactures.
From Jan. 1, 2021, to June 30, 2023:
In case manufacturers have decided to still follow the CE marking process, CE mark labels will be accepted in Great Britain, and information about the United Kingdom representative (UKREP) will not be required to be added.
From Jan. 1, 2021:
If the UKCA marking path will be followed, the UKCA mark will need to be affixed as well as the name and address of the UKRP. In this case, dual marking (CE and UKCA) on the labels will be accepted by the MRHA.
From July 1, 2023:
The UKCA mark will become mandatory. However, so far the MHRA guideline suggests that dual marking (CE and UKCA) will still be accepted.
Is there anything else you would like to add that was not covered yet?
I guess a quick overview needs to be provided about the Northern Ireland (NI) market and use of the UKNI instead of the UKCA mark. UKNI stands for U.K. Northern Ireland and will be applicable only for devices entering the Northern Ireland market and only for specific cases.
In summary, after the transition period, if the manufacturer will be placing a medical device that has not been self-declared into the NI market and plans to use a UKCA body to carry out the assessment, the CE mark will need to be accompanied by the UKNI mark as well. To place goods in the EU market, manufacturers must use the CE marking on its own without the UKNI marking. Goods bearing the CE and UKNI marking will not be accepted into the EU market.