The implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical investigations. Indeed, whereas the previous directives (93/42/CEE&90/385/EEC) only dedicated an article to this matter, the MDR has 20 articles and an annex.
All these changes may seem challenging to implement, especially in the case of ongoing clinical investigations. To support sponsors with the design and implementation of clinical investigation, we have developed a practical guide bringing together the experience of our clinical team.
Where does the complexity of clinical research come from?
To answer this question, we may first define a clinical investigation. According to the international standard ISO 14155 on Good Clinical Practice (Clinical investigation of medical devices for humans, with the last version released being ISO 14155:2020), a clinical investigation is a systematic investigation in one or more human subjects to evaluate the clinical performance, effectiveness or safety of a medical device.
ISO 14155 provides guidance and requirements for the design, conduct, recording and reporting of clinical investigations in accordance with the MDR and the ethical principles set out in the Declaration of Helsinki. Together, these documents set out the basis for ensuring the safety of clinical investigations of medical devices. These documents must be followed by sponsors, investigators and other stakeholders (clinical research organisations, ethics committees, regulatory authorities) to ensure:
That rights, safety, dignity and well-being of the participants are protected and prevail over interests of science and society; and,
That the clinical data generated are clinically valid, reliable and robust.
Therefore, it is essential to ensure that clinical investigations accomplish all legal and contractual aspects, contain all the required documentation and meet all ethical requirements. This process is analogous to a mechanical watch: all springs within the clinical clockwork must run correctly. However, the lack of knowledge in the field, the pressure to avoid delays, or even the lack of resources, among other issues, can lead clinical investigations to failure.