About ABHI

Regulatory

Overview

The Regulatory Group is ABHI’s main forum for developing and communicating policy on regulatory, environment and standards issues. It aims to ensure regulations provide safe and timely access to HealthTech whilst maintaining the balance between risk and benefits for patients.

Leadership 
  • Chair - Lynn Heaver, Johnson & Johnson Medical Ltd
  • Vice Chair - Cait Gatt, Boston Scientific
Achievements
  • In 2019, the ABHI Regulatory Group provided the go-to forum for both industry and policy makers to tackle the ongoing challenges with Medical Device Regulation/In Vitro Diagnostic Regulation implementation. It helped raise the profile of the issues, increase the activity of our stakeholders and deliver 1-1 support for members.
  • The group continued to provide up-to-date insights on the impact of Brexit on the regulatory environment.
  • Our green paper Future UK regulatory frameworks post-Brexit was published in 2019 and has successfully started a debate on what the future of our regulatory framework looks in a post-Brexit global environment.
Priorities
  • To understand, influence and assess the impact of medical device and in-vitro diagnostic regulations and guidelines within a national and international framework. As part of this, to deliver the annual ABHI Regulatory Conference.
  • Understand, influence and assess environmental regulation and the development and application of standards which support the regulations.
  • Develop consensus positions to inform and influence the global regulatory community.
Useful Resources

Click here to view the latest updates, minutes and future meeting dates for the group. 

 

“Regulation is at its most effective when industry has strong engagement with, and understanding of the regulatory context in which they are operating. ABHI’s secretariat do an excellent job of bringing together their broad membership to ensure views on regulation have been collated and communicated. This is particularly important, as it helps the MHRA to understand the implications of changes to legislation, policy and implementation.”
Graeme Tunbridge, Interim Director of Devices, MHRA