The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. The current deadline for compliance to UK Medical Devices Regulations (UK MDR) 2002 is 30th June 2023, however, the government confirmed on 25th October 2022 that the deadline has been extended to July 2024. This one-year delay will provide industry with more time to transition existing products to the new UK regulation and for more Assessment bodies to become UK Approved Bodies, to ease current capacity constraints and ensure that manufacturers can obtain their certification before the deadline.
UKCA Compliance
The government intends to introduce legislation by Spring 2023. In short, what this means for medical device companies that manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
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Keeping up with Changes and Developments
Since the Brexit, many companies experience an increase in administrative tasks, ensuring proper interpretation and compliance to the UK MDR 2002. With the regulatory landscape continuously changing and will likely further develop during the transition period- it is important to work with your glove supplier who are knowledgeable and savvy in navigating through the new requirements and timeline. SW is up to date with these developments and regulation changes. We assure compliance to both EU and UK regulations and will continue to work with our customers who have questions or not sure of the these changes.