Watch now: A sneak peek into the U.K. Medical Device Regulation
A presentation covering what to expect from the future U.K. medical device regulation, based on the government response to the June 26, 2022, consultation.
Originally, the Medical Device Regulations 2002 (U.K. MDR 2002) stated that the acceptance of CE marked devices on the Great Britain market would end on June 30, 2023. This has now changed.
The transitional arrangements set out in the government response outline an extension to the recognition of CE marked medical devices placed on the Great Britain market, which is intended to be reflected within the U.K. MDR 2002, once it is amended.
The government is introducing a 12-month extension to the implementation of the future Medical Device Regulations, intending to bring the new regulations into force by July 2024.
Manufacturers will be able to continue to place CE marked devices on the Great Britain market after July 1, 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.
If you would like to learn more about the U.K. Medical Device Regulations and gain insights into timelines, requirements, conformity assessments, post-market surveillance and transitional arrangements based on the government response to the consultation dated June 26, 2022, watch our webinar.
If you need further information or support with your medical devices’ compliance, please contact us.