4. Clinical evidence requirement for Medical Devices and IVDs


Clinical evidence requirement for Medical Devices and IVDs

The objective of a clinical evaluation in Medical Devices is to assess the safety and clinical performance of the device in question and to evaluate whether the device is suitable for the purpose(s) and the population(s) for which it is intended [1]. A clinical investigation is defined by the MDR as a systematic investigation involving one or more human subjects, undertaken to assess the safety and performance of a Medical Device. In terms of Medical Devices, performance includes the clinical benefits for patients (see Table 1 below).


The ability of a device to achieve its intended purpose as stated by the manufacturer


The ability of the device to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients


The positive impact of a device on the health of an individual or public health, expressed in terms of meaningful, measurable, patient-relevant clinical outcome(s), including diagnosis or patient management

Table 1. From the Dutch Central Committee on Research involving human subjects for the Medical Research Ethical Committee on Medical Devices [2]

Chapter VI of the MDR deals with the requirements of clinical evaluation and clinical investigations of Medical Devices, that is, what is needed and how to plan, conduct and report on the clinical evaluations [3]. For Class III and some Class IIb devices, the manufacturer may voluntarily consult an expert panel with the aim of reviewing the manufacturer's intended clinical development strategy and proposals for clinical studies. The manufacturer shall give due consideration to the views expressed by the expert panel (MDR chapter VI article 61(2)). Though not explicitly mentioned, patients can be part of these expert panels if they meet the requirements of expertise, independence and impartiality. These expert panels shall also consider relevant information provided by patients' organizations (MDR Article 106(4)).

If the manufacturer can demonstrate that the product is equivalent to an already marketed product, the manufacturer can be exempted from performing clinical investigations before marketing the product.


[1] EU Guidelines on medical devices. Guidelines on clinical investigation: A guide for manufacturers and notified bodies, 2010 MEDDEV 2.7/4

[2] Dutch Central Committee on Research involving human subject, medical device regulation: Review of a clinical investigation with a medical device - guidance document for MRECs (Resource: https://english.ccmo.nl/investigators/publications/publications/2021/05/17/review-of-a-clinical-investigation-with-a-medical-device-%E2%80%93-guidance-document-for-mrecs

[3] EU Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)  https://eur-lex.europa.eu/eli/reg/2017/745/2020-04-24