Early Christmas present: MHRA consultation on international recognition of devices

The MHRA has provided more information on its plans for rolling-out its new medical device framework. It aims to publish its additional consultation on key certain aspects of the new framework in mid-November. The consultation will be open for 6 weeks, presumably closing at the end of the year.

The MHRA confirmed, as we previously speculated, that the cornerstone of the consultation will be the proposed international recognition of medical devices, through an abridged approval route for certain medical devices already approved in Australia, Canada, the EU or the US.

In addition, the MHRA intends to consult on a “more pragmatic approach to IVD regulation”. It will be interesting to see whether this is a nod to the recent EU Parliament’s resolution calling for further revisions to EU IVDR¹, and also EU MDR².

The update also provides some further detail in relation to the MHRA’s plans and timelines for various updates scheduled in 2025. 

Most notably, it aims to publish the full text of the statutory instrument on the core measures of the new framework by spring 2025. As noted previously, this instrument will not only include provisions related to the matters that the MHRA will shortly be consulting on but also will include provisions deriving from the previous consultation from 2021/2022.

The MHRA continues to highlight both IDAP and the AI Airlock as tools to encourage the adoption of innovative MedTech in the UK.

---------------------------------------------------------

[1] In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

[2] Medical Devices Regulation (EU) 2017/745