Impact of Brexit: Medical Devices and CE Marking

This policy statement analyses what the UK must do in regards to medical technology regulation in the wake of Brexit.

Medical devices are highly regulated and currently the UK legal framework that governs these devices originates from long-established EU Directives that have taken EU Member States decades to achieve.

Ahead of the UK leaving the EU, it is imperative that the UK Government acts quickly to create a stable regulatory platform from which device manufacturers can implement any changes necessary to maintain their access to market.

The Institution of Mechanical Engineers recommends:

1. The Government negotiates a Med Tech compliancy arrangement with the EU to ensure continuity in the CE marking process for UK manufacturers. This arrangement should be supported by parallel policies to encourage long-term investment in the sector. The goal is to attract Med Tech SMEs to the UK through clear support for innovation and product development.

2. UK industry and the NHS work together to ensure that they retain influence over future European regulation. This influence could flow from the purchasing power of the NHS but should also be based on more formal post-Brexit arrangements negotiated by the UK Government on its behalf.

3. UK Research and Innovation must address the EU funding short-fall. This must take the opportunity to remove the current imbalance in support between early-stage start-ups and large established companies. A full commitment to implementing the Accelerated Access Review would go a long way to addressing this.