The UK’s departure from the EU on 1 January 2021 marked the introduction of a new product conformity mark known as the UKCA mark in Great Britain. To minimise the impact of this change on businesses, a 12-month transition period was implemented, and during this time economic operators in Great Britain were able to use either the UKCA mark, the CE mark, or both. As of 1 January 2022, economic operators would need to ensure that their products were UKCA marked if they were to be introduced to the market in Great Britain for the first time.
However, the UK Government announced on 14th November 2022 that CE marking will continue to be recognised in Great Britain until 31 July 2024. This extension gives medical device businesses additional time to prepare for the mandatory implementation of the UK Conformity Assessed (UKCA) marking. Companies can voluntarily use the UKCA mark until then, allowing them to choose which marking to use and offering them greater flexibility.
The MHRA’s recent decision to postpone the implementation of the upcoming UK Medical Device Regulations from 1 July 2023 to 1 July 2024 is the basis of this recent announcement. The latest MHRA announcement is here.
The UKCA marking announcement applies to most categories of products that formerly required CE marking, including medical devices. As a result of this announcement, medical devices with a CE mark continue to be accepted in Great Britain, and medical device manufacturers will only be required to obtain a UKCA mark from July 2024.
The CE mark declares compliance with EU health, safety, and environmental protection legislation and confirms that a product meets the relevant requirements. The UKCA mark, however, indicates compliance with UK legislation.
To prove that your medical device complies with the requirements of the UK MDR 2002, you are required to conduct a conformity assessment, which will depend on the classification of your device. You may also choose to use any international standard designated to the UK MDR 2002. Adhering to these designated standards will also guarantee compliance with the relevant parts of the EU directive covered by those standards. While the use of standards is not obligatory, most manufacturers choose to use them.
If you need support for clinical research to demonstrate the safety and efficacy of medical devices, or strategic support to achieve compliance, Clinicology is here to help. We offer a range of activities, including scientific advice and regulatory agency interactions, European CTA submissions for clinical trials covering medical devices as well as CTIMPs. All employees are trained in ISO14155:2020.
With Clinicology’s expertise and experience in the industry, you can be assured that your clinical trial regulatory needs are in good hands. To discuss your specific requirements, please don’t hesitate to get in touch.