Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE Mark

With UK's exit from the EU (Brexit), a transition period also has started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period.

These plans concern both medical devices and in vitro diagnostics. The UK sees the plans as an opportunity to introduce new regulations after Brexit in order to strengthen the public health sector. The aim is to promote patient safety and innovation. A separate mark, the UKCA (UK Conformity Assessed) mark, will indicate that these new regulations have been implemented.

What measures are planned? 

• Strengthening the Medicines and Healthcare products Regulatory Agency (MHRA) in its enforcement of high-risk products such as implants to ensure the performance of these products and patient safety.
• Expanding existing regulations to meet public demands for medical device performance and patient safety.
• Identifying and reducing differences in patient populations across the medical device lifecycle. 
• Making the UK the focus of innovation, with the aim of giving the UK population better access to new, highly innovative products.
• Setting world-leading standards, recognisable through the new UKCA mark to replace the CE mark. The UKCA mark will then show that safety, health and environmental aspects have been met in the manufacture of medical devices. As well as enhancing its reputation, the MHRA expects this to lead to growing partnerships with other regulatory bodies.

A press release issued by the MHRA provides further information.