The Government is committed to the safe and effective regulation of medical devices in the United Kingdom; we continue to strengthen safety while ensuring patients and the public have fast access to new, innovative devices.

While the Government considers the existing regulatory framework to be fundamentally sound, it has been instrumental in securing tougher regulations for medical devices across the European Union. The new EU Medical Devices Regulation (MDR), which fully applies from May 2020, maintain the strengths of the existing regulatory system, of which rapid access to market for new devices is a key aspect, whilst addressing the acknowledged weaknesses in the system. These include improving the standard and consistency of Notified Bodies, enhancing vigilance and post-market safety surveillance systems and improving the consistency of implementation of medical device legislation across the EU.

In the interim, steps have been taken to place more stringent requirements upon manufacturers. In 2016, a new guidance document was published on clinical evaluation. This sets out clearly the need to strengthen the clinical evidence on which a device is CE-marked. The information is available at the following link:

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/

The MDR has further built on these expectations by introducing a higher threshold for clinical evidence before devices are allowed to be used in patients.

This will result in a significant strengthening of the regulatory framework and addresses a number of the concerns raised by the public around patient safety.