Held in Madrid on 6-7 February 2022, the 6th EUCROF Congress “Clinical Trials in a New Era” proved to be an important forum to discuss changes which clinical research is currently facing.
EUCROF, the European Contract Research Organization Federation, is a non-profit organization founded in 2005 with the aim to promote Clinical Research by improving the knowledge, competence/expertise and skills of Contract/Clinical Research Organisations (CROs) in Europe. EUCROF represents and supports the interests of CROs in Europe, towards regulatory bodies, the pharmaceutical, biotech, medical device and other healthcare related industries in the clinical research, as well as the medical and affiliated research community. Regulatory Authorities recognise EUCROF as the representative for European-based CROs, regularly calling on EUCROF to contribute to the debate on the improvement of rules and regulations.
Eng. Marina Torre, Istituto Superiore di Sanità, which is one of the partners of CORE-MD, gave a presentation at the EUCROF Congress on “The experience of Italy in implementing the National registry of implantable prostheses (RIPI)” in the session “The New Medical Device Regulation Environment and Need for Clinical Evidence”. In the presentations of this session, an overview has been given of different kinds and steps of the research related to the development of a medical device.(see the congress programme).
In her presentation, Eng. Torre introduced the aims of medical device registries as valuable tools to support patient safety. She pointed that MDR 2017/745 enhances the role of registries , in particular, in its Art. 108 Device registers and databanks, Art. 83 Post-market surveillance system of the manufacturer, Annex VII – 4.11 Requirements to be met by Notified Bodies – Process – Recertification. The quality and robustness of registry data are needed for regulatory decision making and how completeness is an important issue in the use of registry data for regulatory purposes. Therefore, the speaker cited a paper of Prof. Alan Fraser, CORE-MD coordinator, to stress that “a comprehensive recruitment might be attained by stipulating that entering data in a registry is a condition for institutional reimbursement”. Eng.Torre outlined that the aim of CORE-MD is to review and develop methodologies for the clinical investigation and evaluation of high-risk medical devices, by preparing expert consensus recommendations focusing, in particular, on cardiovascular, orthopaedic, and diabetes devices that represent the majority of high-risk medical devices and to exemplify devices used to reduce mortality and morbidity. Therefore, CORE-MD will have an important role and a direct impact in defining methodologies to support MDR implementation. Indeed, the recommendations from the CORE–MD consortium will be presented at the Working Group on Clinical Investigation and Evaluation of the Medical Device Coordination Group, the statutory committee of all EU medical device regulatory agencies coordinated by the European Commission.
The need to make available standards for the variables collected by national registries emerged as an important prerequisite to support clinical research and provide evidence to improve the quality of care, a need that CORE-MD will meet, in particular with the deliverables produced by WP3.