In March 2017, we published an article on the potential impact of Brexit on the UK medical devices sector.
The article looked at whether the UK’s medical devices sector would be best served by continuing to be regulated by EU directives. Some of the arguments employed to support working with the same legal framework are to:
- encourage investment in the medical devices sector;
- allow free access to the European market for medical device manufacturers;
- give greater certainty to the NHS in terms of purchasing medical devices; and
- clarify the position of foreign nationals working within the medical devices sector.
It now appears that medical device trade associations are lobbying for many of the same things that Wright Hassall predicted at the beginning of the year. The Association of British Healthcare Industries, British In Vitro Diagnostics Association and MedTech Europe (the “Associations”) have written a letter to the chief negotiators in the Brexit process, Michel Barnier and David Davis, calling for certain fundamental issues to be agreed between the UK and the EU to provide certainty for the UK medical devices industry going forward. These factors outlined by three groups mentioned above are set out below:
- The UK should remain active within the regulatory framework for medical devices and should implement fully the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (the “New Regulations”);
- The Medicines and Healthcare products Regulatory Agency, which regulates medicines, medical devices and blood components for transfusion in the UK should have a formal role in the European Commission’s new Medical Devices Coordination Group;
- UK notified bodies, as listed under the medical devices directives, should remain European notified bodies;
- Legal bodies, such as manufacturers of medical devices, which are located within the UK should continue to be considered “European based” under the New Regulations; and
- The UK should continue to have full access to the European Database for Medical Devices.
Small and medium enterprises (“SMEs”) are integral to the success of the UK medical devices sector. As a result of Brexit, many SMEs operating in the UK medical devices sector could:
- lose access to research funding;
- be priced out of the market;
- lose access to key skills from industry specialists; and
- face additional running costs.
Taking into account the potential risks facing the SMEs operating in the UK medical devices sector, regulatory alignment could be essential to the future of the SMEs operating in the UK medical devices sector and the success of the UK medical devices sector as a whole.