Medical Device Regulation

Clinical Investigations of Medical Devices

Clinical investigations are a key feature of the Medical Devices Directive. They will be even more important under the forthcoming Medical Devices Regulation.  Companies carrying out investigations have access to a wide range of guidance. At ABHI, we have also published our own guidance.  This page aims to direct you to the appropriate starting point.

ABHI’s Clinical Investigations Guidance

We have published the following documents to support members:

EU Clinical Investigations Guidance

The following documents can be found on the European Commission web site:

  • MEDDEV 2.7/1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies
  • MEDDEV 2.7/1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies - Appendix 1 Clinical Evaluation of Coronary Stents
  • MEDDEV 2.7/2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC
  • MEDDEV 2.7/3 Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form
  • MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

MHRA Guidance

If you need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device, you must inform MHRA if you are planning to do this at least 60 days before starting your investigation.

IRAS

The Integrated Research Application System (IRAS) is an online system for preparing regulatory and governance applications for health and social care research. It is UK-wide and provided by the Health Research Authority (HRA).

Model Clinical Investigations Agreement

ABHI worked closely with the Department of Health to develop the model Clinical Investigations Agreement (mCIA). This is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service. Versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.

The bipartite mCIA for use by NHS Trusts and the medical technology industry has also been adapted for use in a tripartite format by NHS bodies, sponsors and Contract Research organisations (CRO). The changes made to the mCIA are based on the changes made to the mCTA in developing the CRO mCTA. The tripartite agreement can now be used when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation.

It has been reviewed by representative bodies as before (NHS Hospitals, the NHS Confederation, the NHS R&D Forum, the Medical Schools Council, medical technology companies, CROs, ABHI and the CCRA). All the bodies have either endorsed the CRO mCIA or do not object to its use as a standard agreement template for investigations of medical technology devices.

Versions of the CRO mCIA for use in the Devolved Administrations have also been developed.

National Institute for Health Research

The mission of the National Institute for Health Research (NIHR) is to maintain a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and public.

HRA Approval

HRA Approval is now the process for applying for approvals for all project-based research in the NHS led from England.  There are compatibility arrangements in place with the national coordinating functions of the devolved administrations so that they will share any studies they lead on which have sites in England with the HRA.  Applications are made through IRAS and bring together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK research ethics service.