Clinical evaluation of medical devices
The Council Directive 93/42/EEC was the standard applicable since 1993 for all medical device manufacturers. In 2017, the European Commission decided to harmonize European practices and implemented the Regulation (EU) 2017/745.
Following difficulties in applying this regulation, the European regulatory bodies have proposed a transition period, also called a grace period, during which both regulations, Council Directive 93/42/EEC and Regulation (EU) 2017/745, are applicable. The deadlines for compliance with Regulation (EU) 2017/745 have thus been extended until 2027 for class IIb and class III devices and 2028 for class IIa devices.
Among the obligations of medical device manufacturers, the clinical evaluation has an important place. Clinical evaluation consists of an ongoing process of collecting, analyzing, and evaluating clinical data related to the use of a medical device in accordance with its intended use in order to demonstrate its performance and safety. Clinical evaluation is essential and is an integral part of the regulatory life cycle of a device, just like Post-Market Surveillance (PMS)
Figure 1 : Regulatory life cycle of a medical device :
CDP : clinical development plan ; CEP : clinical evaluation plan ; CER : clinical evaluation report ; PMCF : post-market clinical follow-up ; PMS : post-market surveillance ; PSUR ; SSCP : Summary of Safety and Clinical Performance.
The different stages of the clinical evaluation of a medical device are illustrated in Figure 2.
The clinical evaluation plan (CEP) describes the methodology for collecting the data that will be used to demonstrate the performance, the safety, and the benefit/risk ratio of the medical device for the patient during clinical evaluation.
The plan is defined prior to the analysis, which is recorded in the clinical evaluation report (CER). The CER is an essential element of the technical documentation of the medical device. It includes the results of risk management, PMS, Periodic Safety Update Report (PSUR), biological evaluation, preclinical studies, clinical investigations as well as a review of the literature carried out on the medical device evaluated, its equivalent or its similar.
Thus, the CER summarizes the analysis of the available data on the assessed medical device to demonstrate its compliance with the General Safety and Performance Requirements (GSPR) defined by Regulation (EU) 2017/745. A Post Market Clinical Follow-up (PMCF) plan is established and then implemented after obtaining the CE marking to describe the PMCF applied to fill any compliance gaps identified during the clinical evaluation and/or to collect data that will be considered during the next update of the technical documentation. These results are then transcribed in a PMCF report.
The clinical evaluation must be carried out as part of an initial CE marking application and is updated periodically (every 1 to 5 years depending on the risk class of the device and its history on the market). This allows the verification of the medical device compliance with regulatory requirements throughout the life of the product. The documents (CEP, CER, PMCF plan and PMCF report) resulting from the clinical evaluation are systematically audited by the notified body during an application for initial or renewal CE marking for all classes of medical devices, except class I (self-marking). For the latter, clinical evaluation remains mandatory.
The application of Regulation (EU) 2017/745 has increased the level of requirements to demonstrate the performance and safety of a medical device. Many manufacturers have now the obligation to perform clinical investigations on their products to gain access or to keep access to the European market. The use of claimed equivalence between medical devices becomes very complex. Strict biological equivalence is expected, and technical and clinical equivalences are reinforced. Moreover, in the case of class III and IIb implantable devices, the use of clinical data of an equivalent is only permitted if a contract between the manufacturers (usually competitors) is established beforehand, which makes this strategy of obtaining data almost impossible.
Medical devices previously CE marked under the Council Directive 93/42/EEC are called “legacy devices”. For these, the clinical data gathered before and after obtaining the CE marking as well as the PMS and PMCF data generated since access to the market of the device can be used to obtain certification under the Regulation (EU) 2017 /745.
In addition to the changes in clinical evaluation strategy that manufacturers have had to face with the application of Regulation (EU) 2017/745, expectations regarding the definition of medical devices indications and performance, benefit, and safety claims have also been raised. Indeed, under Regulation (EU) 2017/745, indications and claims must be precisely defined (and quantified regarding the clinical benefit claim). They must also be supported by a sufficient level of evidence, defined when establishing the clinical strategy.
Regulation (EU) 2017/745 also introduced a new document appended to the clinical evaluation: the summary of safety and clinical performance (SSCP), which is mandatory for all implantable devices or class III devices. This document, published on the EUDAMED database after validation by the notified bodies, allows healthcare professionals and patients to have direct access to the safety and performance data of the device evaluated.
To clarify certain elements of Regulation (EU) 2017/745 and provide methodological assistance to manufacturers and notified bodies for the establishment of a medical device technical documentation, the CER in particular, numerous guides from the Medical Device Coordination Group (MDCG) are published regularly and are available free of charge.
Additionally, a draft of an ISO18969 standard to normalize practices and strengthen the clinical evaluation process is currently prepared by the International Organization for Standardization and is planned for publication in 2024-2025.
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