The MHRA recently published its intention to put into place a 12-month extension to the UK’s transitional arrangements. Currently, the UK MDR 2002 states that CE-marked devices will be accepted on the Great Britain (GB) market until the end of June 2023. However, this will now change.
The MHRA will introduce an extension to the implementation of their future Medical Device Regulations, with the aim to bring them in force by July 2024. Good news for manufacturers who are leveraging their CE-marked devices to access the GB market, you can now continue to do so until the end of June 2024, giving you a little more breathing space to prepare.
This change in the UK’s transitional arrangements will be reflected in the UK MDR once amended. For a copy of the MHRAs notice to delay, please follow this link. [Implementation of the Future Regulations]
For manufacturers needing consultancy support, please do not hesitate to contact the team at Advena: info@advena.mt
