Clinical Evaluation is one of the central parts of MDR. Correspondingly already its preamble calls it a key element (4) and article 10 lists clinical evaluation as General obligation of manufacturers. MDR defines clinical evaluation as:
"systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer" (article 2/44).
Clinical evaluation forms the basis of the General safety and performance requirements acc. to annex I. Article 61 as well as part A of annex XIV define clinical evaluation in detail referring to the benefit-risk-ratio. Article 61 (3) explains the basis of the procedure which needs to be defined and methodologically sound. For implantable devices clinical investigations are required according to 61 (4). Finally, annex XIV lists the details on how to perform a clinical evaluation.
MEDDEV 2.7/1 defines clinical evaluation with even more details. In June 2016 its revision 4 was published which still refers to MDD and AIMDD. Rev. 4 sharpens some of the requirements considerably. MDR already contains some of these points which have thereby become legal character. Among these sharpened requirements are:
In the area of in-vitro diagnostics manufacturers have to perform a performance evaluation instead of a clinical evaluation. According to IVDR performance evaluation is defined as
"assessment and analysis of data to establish or verify the scientific validity, the analyitical and, where applicable, the clinical performance of a device" (art. 2 (44)).
Article 56 as well as annex XIII contain the respective requirements.
Furthermore, Medical Device Coordination Group (MDCG) has published some Documents concerning several aspects of clinical evaluations and investigations. Althouth MDCG has been formed as an expert committee as asked for by MDR / IVDR its guidance are not laws but they are as binding as the respective MEDDEV documents and should be observed as far as possible:
MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
MDCG 2020-5 Clinical Evaluation - Equivalence
MDCG 2020-6 Clinical evidence needed for medical devices previously marked under Directives 93/42/EEC or
90/385/EEC
MDCG 2020-13 Clincal evaluation assesment report template
MDCG 2021-6 Questions & Answers regarding clinical investigations
Even after coming into force of MDR MEDDEV 2.7/1 is still valid as can be seen especially from MDCG 2020-13.