Sufficient clinical evidence under the MDR for class I legacy devices

This article discusses the major aspects covered by the guidance document MDCG 2020-6, Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC, herein referred to as legacy devices. It looks at the paper through the glasses of a class I medical device manufacturer. 

The document generally explains how sufficient clinical evidence is defined and what constitutes sufficient clinical evidence for legacy devices. This is of vital importance because article 61(1) of the medical devices regulation (MDR) defines this as an ultimate requirement for a valid clinical evaluation.  

Basic considerations

MDCG 2020-6 defines sufficient clinical evidence as “the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits” (MDCG 2020-6).

For legacy devices it should be noted that clinical data collected under the medical devices directive (MDD) and post-market clinical data will be used for the medical devices regulation MDR clinical evaluation. In addition, class I devices that may make use of the extended transition period, must nonetheless fully comply with the MDR requirements on post-market surveillance (PMS) or post-market clinical follow-up (PMCF) respectively as of May 26, 2021.  

This may represent a specific challenge for manufacturers of reusable surgical instruments, most medical device software, certain substance-based products, etc. Although these products may be placed on the European market under the MDD until May 25, 2024, PMS data generated under MDR requirements might force manufacturers to update their risk management, clinical evaluation or labeling. This in turn might lead to a significant change and require immediate full MDR compliance.  

Clinical evaluation plan

MDCG 2020-6 provides information what gaps between the MDR and MEDDEV 2.7/1, rev. 4 requirements on the clinical evaluation plan exist and suggests how to close these gaps. A manufacturer should look at the additional explanations regarding the intended clinical benefits and the determination of required level of clinical evidence as these aspects seemingly move further into focus. 

Similar devices and well-established technologies

Although MEDDEV 2.7/1, rev. 4 already refers to well-established technologies and similar devices, MDCG 2020-6 contains further explanation how to embed these two concepts in the clinical evaluation process. Similar devices should be considered separately from equivalent devices where basing the clinical evaluation on the latter has grown increasingly difficult under the MDR. This has already been discussed in a previous article. Similar devices and well-established technologies may be of particular relevance for class I medical device manufacturers as discussed further below. 

Pre- and post-market data

MDCG 2020-6 also explains which pre- and post-market sources may be used for the identification of clinical data and that clinical data is defined more narrowly under the MDR as opposed to what was possible under the MDD. For post-market data, however, the document also specifies that clinical data from similar devices may be used under certain circumstances. 

Data appraisal and analysis

In terms of clinical data appraisal, MDCG 2020-6 mainly references to MEDDEV 2.7/1, rev. 4 and provides recommendations for commonly recognized and validated assessment tools. In this context, it is mentioned that where a manufacturer relies on pre-clinical data, additional clinical data from PMCF may support the device’s safety and performance claims. 

Clinical data analysis should also generally follow the principles of MEDDEV 2.7/1, rev.4 but the clinical evaluation must demonstrate compliance with the general safety and performance requirements (GSPR). The analysis should comprise considerations regarding clinical benefits, risks, the benefit-risk determination in the context of the state-of-the-art and a rationale regarding the level of clinical evidence to demonstrate GSPR conformity.  

Concluding points

MDCG 2020-6 makes a point, which seems to be especially important. On the one hand, it says that even well-established technologies may require additional clinical data from PMCF if relevant literature is not available. This might be the case for many class I medical devices because these products are subject to regulatory interest and thus research to a lower degree. On the other hand, if a low risk device belongs to the group of well-established technologies with a low innovation potential, less clinical evidence possibly coming from similar devices may be necessary. This is possible only under certain conditions, for example if potentially backed by PMS data.  

The latter point may help manufacturers of class I medical devices to justify

The latter point may help manufacturers of class I medical devices to justify using pre-clinical data and data from similar devices to comply with the MDR safety and performance requirements. In this context, annex III of MDCG 2020-6 appears useful because it introduces twelve hierarchical levels of clinical evidence that may be used to support the rationale. 

To summarize, adopting the MDR clinical evaluation requirements remains a challenging task, but MDCG 2020-6 provides useful insights to overcome the hurdles.

Source: MDCG guidance document

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