Question
To ask His Majesty's Government why the use of both the UK Conformity Assessment mark and the EU’s CE mark will be allowed indefinitely for UK companies in the electronic, industrial, consumer and other sectors, but not for medical products produced in the UK.
Answered on
12 September 2023
Medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and are considered high-risk goods. The Government has put in place legislation to extend the acceptance of CE marked medical devices on the Great Britain market up to 2028 or 2030, depending on the type of CE certificate held.
In addition, the MHRA are currently developing proposals for an international recognition framework. This would reduce, where safe to do so, barriers to medical devices entering the Great Britain market where they have already demonstrated to other trusted regulators that they meet our essential requirements.