Entry into force of Regulation 2017/745 on medical devices (MDR): update on clinical evaluation

Regulation 2017/745 on medical devices(MDR) entered into force on 26 May 2021 with the notable objective of evolving clinical evaluation, notably through the strengthening of the use of equivalence, post-marketing surveillance or the EUDAMED database.

Conducting a clinical evaluation according to Regulation 2017/745

The clinical evaluation must be integrated into the manufacturer's quality management system (QMS), which is now also required for Class I MDs - although there is still no audit by a Notified Body (NB) for this class.

This evaluation is now an obligation for all devices in all classes.

The aim here is to obtain sufficient clinical evidence to :

• confirm compliance (safety and performance),
• assess adverse effects
• assess the acceptability of the benefit/risk ratio

The manufacturer plans, carries out and documents its clinical evaluation: it must therefore justify the level of clinical evidence and will have to demonstrate on an ongoing basis that the benefit/risk ratio remains favourable, including the establishment of a post-market surveillance (PMS) system according to the risk class and type of device.

All of the following documents are now part of the technical documentation to demonstrate compliance with the provisions of the MDR:

• The clinical assessment plan (see Annex XIV)
• The Clinical Assessment Report (CAR), which must be updated throughout the life cycle of the device
• The post-marketing surveillance (PMS) plan including the post-marketing clinical follow-up plan (PMCF) which should describe the methods and procedures to be followed to proactively collect and evaluate data
• The SCAC assessment report, updated annually for Class III devices and implantable medical devices(IMDs)

The Summary of Safety and Performance Characteristics (SSPC), which acts as an enhanced leaflet available to the public on EUDAMED, is mandatory for IMDs and Class III devices and containsthe elements listed inArticle 32 of the MDR.This summary should be updated annually

Obtaining data for clinical evaluation in practice

The ways of obtaining clinical data are manifold and can consist of :

• clinical investigations of the device concerned
• investigations or other studies cited in the scientific literature of a device that can be shown to be equivalent to the device concerned
• reports in peer-reviewedscientific publications of any other clinical trials of the device concerned or of a device whose equivalence can be demonstrated
• clinically relevant information from post-marketing surveillance, in particular post-marketing clinical follow-up (PMCS)

The use of clinical investigations (see Entry into application of Regulation 2017/245 - point on clinical investigations) is mandatory for class III IMDs and devices unless:

• The MD has been designated by modifying a device already marketed by the same manufacturer
• The modified MD is equivalent to a marketed device (demonstrated by the manufacturer)
• The clinical evaluation of the marketed device is sufficient to demonstrate compliance of the modified device

As for access to clinical data (technical documentation) of the device considered as equivalent, this must be proven by the similarity of technical, biological and clinical characteristics with an appropriate and now reinforced clinical justification (see Annex XIV).

In practice, for IMDs or Class III devices, the manufacturer must enter into a contract with another manufacturer, usually a competitor, granting full access to the technical documentation of the MD demonstrated to be equivalent. For other MD, only "sufficient" access to data is required. However, the demonstration of equivalence may be difficult in the case of limited access to the technical documentation of the equivalent device. The guidance in MDCG-2020-5 outlines how to demonstrate equivalence in accordance with the MDR.

The SCAC is another major reinforcement of the MDR obligations by establishing a process for continuous and proactive updating (as opposed to vigilance) of the clinical assessment. The SCAC plan should describe the methods and procedures to be followed to proactively collect and evaluate data (see Annex XIV Part B). The SCAC findings will be documented in a SCAC evaluation report as part of the technical documentation.

For innovative MDs, the enhanced clinical evaluation procedure known as " scrutiny" (see Article 54) is added to the classic certification procedure carried out by the NBs. It consists of a consultation of a panel of experts, appointed by the European Commission, on new class III and IIb implantable devices with medicinal products. This panel of experts provides a public scientific opinion (via EUDAMED) on the clinical assessment report drawn up by the NB on the basis of the clinical evidence provided by the manufacturer, and in this sense allows for a double check.

Clinical assessment, summary table

From product design to post-marketing activity, the evolution of clinical evaluation therefore has a significant impact on the manufacturer's obligations and requires as such the upgrading of activities and technical documentation.