Regulatory
Overview
The Medical Device and IVD Regulatory Groups are ABHI’s forums for developing and communicating policy on wider regulatory, environment and standards issues including those covered by UK CA marking, EU MDR and 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, whilst maintaining the balance between risk and benefits for patients.
The groups also bring together a sub group on the decontamination of HealthTech products, that is developing a programme of work supporting decontamination of medical devices and IVDs.
Leadership
Medical Device Regulatory
- Chair - Lynn Heaver, Johnson & Johnson Medical Ltd
- Vice Chair - Cait Gatt, Boston Scientific
IVD Regulatory
- Co-Chairs Sue Spencer, Qserve Group UK, Ltd
- Vice Chair Megha Iyer, Global Strategic Regulatory Affairs Director, Thermo Fisher
Achievements
Medical Device Regulatory
- Significant and comprehensive input into the UK CA Marking sub-group to influence future UK regulatory framework, including detailed response the MHRA consultation.
- Ensured external presentations into all group meetings on a number of wide-ranging topics, including standards and MHRA process and procedures.
- Included a number of international regulatory presentations in the group discussions, including from Swiss Medtech and MedTech Europe.
IVD Regulatory
- Significant and comprehensive inputs that influence future UK regulatory framework.
- Detailed responses to MHRA consultations on
- IVD common specifications.
- Coronavirus Test Devices Approvals (CTDA).
- MHRA fees proposals.
- UK premarket requirements (including international reliance and IVD classification).
- Worked with MedTech Europe in contributions to IVDR transition, future regulatory systems and targeted evaluation.
Priorities
Medical Device Regulatory
- To work with members of the IVD and digital interest groups to develop a regulatory oversight group, that will ensure messaging is consistent with wider ABHI policy.
- Ensure that ABHI and its members are recognised as the senior partner in MHRA’s efforts to progress CA Marking, particularly with respect to timely inputs into the respective consultations.
- To develop a strategy for education and encouragement for the group, thereby fostering an environment of participation by members.
IVD Regulatory
- Build a strong IVD regulatory group to establish authoritative leadership in the UK.
- Drive the UK industry response to the emerging UK regulatory framework.
- Influence and assess the impact of new IVD regulations and guidelines in the EU and internationally.
Useful Resources
Click here to view the latest updates, minutes and future meeting dates for the group.
Get Involved
To join the ABHI Medical Device Regulatory group, contact phil.brown@abhi.org.uk
To join the ABHI IVD Regulatory group, contact stephen.lee@abhi.org.uk
“Being part of the regulatory group is empowering. To be able to have like-minded discussions with peers across many companies only expands your own knowledge. And in our current environment of the MHRA consultation on the future of medical devices, now is the time we can all create change and innovation, to develop along with MHRA the best regulatory system to ensure access to devices for our patients in the UK. As George E. Woodberry said ‘Defeat is not the worst of failures. Not to have tried is the true failure."
Lynn Heaver, Johnson & Johnson Medical Ltd
