ABHI/ICR/MHRA Clinical Investigations Working
Group
This group is a tripartite group of ABHI, Institute for Clinical Research and the Medicines & Healthcare products Regulatory Agency.
Membership of this group is restricted.
The group has two main areas of activity:
- To monitor the European situation with regard to clinical investigations of medical devices
- To monitor the UK situation with regard to clinical investigations of medical devices.
ABHI has collaborated with the UK Medicines and Healthcare products Regulatory Agency (MHRA) to produce a number of documents designed to assist manufacturers carrying out clinical investigations. It is suggested that manufacturers should read all the relevant documents from ABHI, MHRA and also the Central Office for Research Ethics Committees before undertaking a clinical investigation in the UK. MHRA welcomes informal approaches from manufacturers before they decide to submit an application to review their proposed clinical investigation design and technical data on their study device. The WG strongly recommends this approach for manufacturers with limited experience of designing and implementing clinical investigations
ABHI will welcome feedback and comments on the documents below.
Clinical Research Flowchart
Sets out in schematic form the processes through which a manufacturer should go when carrying out a clinical investigation for the purposes of CE marking a new medical device.
Clinical Investigations Checklist
The checklist should be used as part of the documentation process when carrying out a clinical investigation. It provides a step-by-step guide to carrying out a clinical investigation and can be used to track progress and the associated documentation.
Clinical Investigations Reference Documents
The reference list gives details of relevant guidance notes, standards and other relevant documents for carrying out clinical investigations in the EU.
Clinical Investigations Compensation Guidelines
The guidelines set out draft provisions for volunteer agreement and consent forms.
Clinical Investigations Position Paper
The position papers sets out ABHI's thinking with regard to clinical investigations
Clinical Investigations Form of Indemnity
This is a standard indemnity form for manufacturers carrying out clinical investigations on medical devices.
The following documents can be found on the European Commission web site:
MEDDEV 2.12-2 Post Market Clincal Follow-Up of Medical Devices under the Medical Devices Directive
MEDDEV 2.7.1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies