The UK government's response to MHRA's 2021 consultation on medical devices regulation in the United Kingdom follows.

This response to the medical device industry is coming at an important moment. The government has been dealing with internal and external delays, but it has finally released their response. Companies are already demanding clarity for compliance deadlines for new regulation. There are less than two years until the deadline arrives and companies don’t want to be left out of compliance.

The MHRA has addressed respondents' feedback on their compliance date, by listening to their concerns. The response provided is 155 pages long with many detailed responses.

The UK regulator will allow CE-marked devices such as catheters and CT machines to transition for three or five years. The conditions for these devices remain on the market for these periods depend on key factors, like the device's nature and type.

The government has put patient safety first in their healthcare reform proposals. This will be accomplished by allowing the MHRA to both regulate and innovate medical devices.

The government intends to make the UK a globally competitive environment for developing medical technology and enhance both innovation and access.

To achieve their goals for the regulation of medical devices, the MHRA will be implementing new policies which promote international trade. The intention is to create global harmonization for medical device regulations and avoid duplication of existing frameworks. The MHRA's ambition is also to minimize the industry's burden and promote international collaboration with like-minded regulators.

The release of this paper is not a surprise, given the reforms to the EU-UK relationship; it is the inevitable consequence.

The government has answered some important questions on what accountability manufacturers should have for their devices. Manufacturers will also be more responsible for the post-market surveillance of these devices. Yet, there is more clarity needed as this drives forward to statutory instruments and statutory guidance.

The medical device industry needs to continue to build relationships with government officials in order to ensure safety and innovation.