Accelerating medical technology innovation: data driven augmented regulatory conformity assessment

There are more than 600,000 unique medical devices on the market in EU and UK ranging from hospital beds to MRI scanners, in-vitro diagnostics, software as a medical device, infusion pumps, brain stimulators and hip replacements.

Medical devices are classified based on the risks associated with them. Lowest risk products such as prescription glasses, are Class I and businesses can self-certify their products and place them on the market.

Higher risk medical devices are placed into either Class IIa, Class IIb or Class III Products that fall into these categories require formal conformity assessment which is carried out by a business called a Notified Body (NB) in EU or UK Approved Body (UKAB) in Great Britain.

A medical device manufacturer must submit a technical file to the NB or UKAB that contains evidence of how the manufacturer has complied with the regulatory requirements. This file can contain 10,000 pages of highly complex information that a person manually reviews and then determines whether a CE Mark of UKCA Mark can be conferred.

New EU medical device legislation has significantly increased legal requirements on Notified Bodies and led to a decrease from 55 to 31\. There is also a critical shortage of trained NB staff and it can take 5+ years to develop people.

For industry this means it can take 6+ months to be taken on by a NB followed by an 18-month conformity assessment process (twice as long as under old Directives) and increased costs circa £60,000\. MedTech Europe estimate that 27% of products will be removed from the market as a direct result of increased costs and timelines.

We will develop a unique data driven platform to support the technical file review process that will revolutionize how NBs undertake conformity assessment.

Technical files would be fed into the system that would be trained to identify the assessment methodology and augment the review by presenting information in a logical and ordered manner (such as identifying device claims, aligning terminology such as biocompatibility with material, and clinical studies). This will enable the reviewer to focus on key aspects and could decrease timelines