The published consultation on the future regulation of medical devices in the United Kingdom by the MHRA allowed the diagnostic industry a first look at the intensions for the innovative device access pathway (IDAP), where the MHRA focused on the opportunity to be “at the forefront of medical device innovation”, thus allowing manufacturers to launch their new and novel devices onto the UK market.
The desire for the UK to be the primary market access for the new device is ambitious and well received, the mechanism for this to happen is still unknown.
The National Institute for Health and Care Excellence (NICE) have provided a little more context on this process in their summary:
“The Innovative Devices Access Pathway (IDAP) is a joint project between NICE and:
- the Medicines and Healthcare products Regulatory Agency (MHRA)
- Health Technology Wales
- the Scottish Health Technologies Group.
Our involvement in the pilot phase of the project is funded by NHSX.
It will research, design and scope an innovative access pathway for selected medical and digital health technologies that:
- are new and innovative
- meet critical unmet needs in the health and care system
- have the support of an NHS organisation or network
- meet relevant safety standards.
The pathway will be piloted with digital health technologies. The aim is to help manufacturers provide their devices to healthcare professionals and patients at the earliest safe opportunity.
The pathway will help developers generate evidence that meets the needs of the regulator and health technology assessment bodies. It will also offer post market access support.”
In order for the UK market to achieve its aim in ensuring continued patient and public safety by establishing a world-leading regulatory ecosystem, the IDAP initiative is a welcomed and exciting prospect for the UK market.
IVDeology are supportive members of the British IVD Association (BIVDA), and Stuart is the current Chair of the Regulatory Affairs Working Party, who have been working with the MHRA on establishing a roadmap for IVDs in the UK. For any information on the UKCA process, or the BIVDA Reg Affairs working party, book a call with Stuart via [email protected]