The CE marking proves that goods on the EU market meet the applicable regulatory requirements. Similarly, with the United Kingdom leaving the European Union, the UKCA marking will be the equivalent conformity proof in the United Kingdom. Indeed, the UKCA marking covers most products which previously needed the CE marking.
Two more years for the CE marking
In November 2022, the UK government announced they would continue to recognise the CE marking in Great Britain for another two years. Thus, manufacturers can use both the CE and UKCA markings for a longer period of time. The original deadline was December 31, 2022. With this recent announcement, manufacturers can use the CE marking until December 31, 2024. However, the mandatory requirements of appointing a UK responsible person or authorised representative – when applicable – have not changed.
Advantages for manufacturers
Manufacturers from outside the United Kingdom will have now more time to prepare for the UK conformity assessment. Moreover, the UK government declared that the country is determined to remove barriers and give manufacturers flexibility to ensure the products’ safety, without damaging businesses. Among others, the United Kingdom is planning to review the product safety framework and introduce more digital methods, such as e-labelling.
A significant additional advantage for manufacturers is that the UK government will allow the use of CE certificates issued by EU Notified Bodies before December 31, 2024, until December 31, 2027. More specifically, the use of such CE certificates will be possible until the end of 2027 or the certificate’s expiration date, whichever comes sooner.
Different rules for medical devices and other products
It is crucial to note that rules will differ based on the products. For instance, different rules will apply to manufacturers of medical devices, construction products, cableways, transportable pressure equipment, unmanned aircraft systems, rail products, and marine equipment. For medical devices, the government of the United Kingdom announced a 12-month extension. Manufacturers can place CE marked medical devices on the market in Great Britain until June 2024. Nonetheless, the mandatory requirement to appoint a UK responsible person has applied since January 2021.
Was this article helpful?
Check Obelis UK News page to keep up to date with the latest Medical Devices and Cosmetics market in the UK.
Simona Varrella
Publications Department
24/11/2022
Would you like to place medical devices on the UK market? Contact us and we will guide you through the process!
References:
- Gov.uk. (2022). Businesses to be given UK product marking flexibility. Retrieved on 24/11/2022.
The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.