InnoScot Health has joined the membership ranks of the UK’s leading industry association for health technology, a move which will enhance its reach thanks to a collaborative approach to contributing to deeper regulatory intelligence.

The Association of British HealthTech Industries (ABHI) supports the HealthTech community to overcome regulatory barriers to access, “so patients can access HealthTech safely and quickly” and help ensure the “industry is recognised as a trusted partner in healthcare”.

InnoScot Health believes that joining the ABHI and gaining first-hand knowledge of the association’s work with regulators and companies in understanding the environment can only enhance its own comprehensive regulatory offering and help it to forge new connections.

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell said: “The ABHI is undoubtedly the voice of the industry with its members – ranging from multinationals to SMEs – accounting for approximately 80% of the sector by value.

“The association is nothing less than a vital partner in boosting the global presence of the UK’s health technology companies and supporting their collaborative ambitions.

“We are excited to be joining the association at an important time and share its belief in the highest professional standards in order to accelerate the improvement of patients’ lives and encourage economic growth across both Scotland and the rest of the UK.

“The ABHI is also a champion for safe, accelerated innovation, aligning with our own key aims at a time when challenges for HealthTech companies are significant despite huge opportunities and receptive global markets.”

She added: “With the ABHI representing the industry to stakeholders, such as the government, NHS, and Medicines and Healthcare products Regulatory Agency (MHRA), we want to be part of its wider conversations in helping to influence the UK regulatory framework.

“Indeed, we’re pleased to note its strong backing for the indefinite recognition of CE-marked medical devices and in vitro diagnostic medical devices in Great Britain – a major step forward if approved.”

The ABHI’s Medical Device and IVD Regulatory Groups are forums for developing and communicating policy on wider regulatory, environment and standards issues, including those covered by UK Conformity Assessed (UKCA) marking, the EU Medical Devices Regulation (EU MDR) and EU In Vitro Diagnostic Regulation (EU IVDR).

The groups work collaboratively with other ABHI member groups “to ensure new UK and EU regulations provide safe and timely access to medical devices, IVDs and digital health products”.

ABHI members supply products ranging from syringes to surgical robots and digitally enhanced technologies.

Elaine continued: “We want to help ensure that ABHI and its members are recognised as a leading voice in assisting MHRA efforts to progress UK medical device regulation”