Understanding Sufficient Clinical Evidence Requirements Under the European Medical Devices Regulation

The European Medical Devices Regulation (MDR) demands that “confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio, shall be based on clinical data providing sufficient clinical evidence.”

Medical device manufacturers should expect that the amount of clinical data required will be significantly increased under the MDR, and that the Notified Bodies will enforce this need for clinical data.

What about legacy devices ?

To address the question, “What is sufficient clinical evidence?“, the Medical Device Coordination Group (MDCG), an expert committee required by the MDR as well as the In-vitro Diagnostic Medical Devices Regulation (IVDR), has generated a guidance document, MDCG 2020-6,  on sufficient clinical evidence needed for medical devices previously CE marked under the Medical Device Directive (MDD) or the Active Implantable Medical Device Directives (AIMDD).

This guidance document points out that:

• Clinical data used for conformity assessment under the MDD does not necessarily provide sufficient clinical evidence for MDR requirements.
• Post-market clinical data plus clinical data generated for the conformity assessment (MDD/AIMDD) are the basis for the MDR clinical evaluation process for legacy devices.

In order to understand the status of the legacy device in question, the MDCG 2020-6 guidance recommends that manufacturers:

1. Establish or update the clinical evaluation plan for the legacy device.
2. Conduct a gap analysis.

For the gap analysis the MDCG 2020-6 document proposes to identify all available clinical data collected on the device in question, or data on similar devices prior to  CE Mark certification and clinical data collected through post-market activities. Second, this data needs to be assessed regarding methodological quality and scientific validity.

Reference is made to MEDDEV 2.7/1 rev. 4, the MEDDEV guidance document on clinical evaluation under the MDD and AIMD, and lists sections of this MEDDEV remain relevant under the MDR. This document provides guidance on how to:

• Evaluate methodological quality and scientific validity of the clinical data;
• Determine the relevance of the available clinical data; and
• Weigh the contribution of each data set.

Once the quality and validity of each available data set is assessed, the clinical data needs to be evaluated to determine whether all products (including different models or sizes or settings) are covered, and whether all indications and/or conditions in which the device is intended to be used are addressed in order to support the continued acceptability of the device’s benefit-risk profile. This assessment will lead to the identification of potential data gaps to be closed with clinical activities such as post-market clinical follow-up (PMCF) clinical investigations.

Are PMCF data needed for CE re-certification under the MDR?

The need for PMCF data will depend on the device itself, the risk classification of the device, the previous clinical evaluation and on the clinical data available for the device.

If, for example the need for a PMCF study was already identified during the previous clinical evaluation process for a medical device, manufacturers are expected to have these activities planned and initiated when it comes to re-certification. Where reasonable, manufactures will also need to provide data from these clinical activities.

Please be aware that during the period of validity of the MDD and AIMDD CE-certificates, the MDR requirements for post-market surveillance (PMS) apply from the MDR date of application on May 26, 2021. This means that, manufacturers are expected to have a PMS system established or updated, including a PMS plan and a PMCF plan, currently by the MDR date of application.

PMCF study data might not necessarily be needed  for re-certification (yet). However, as mentioned above, we expect that PMCF activities need to be at least planned and initiated for the majority of the medical devices currently on the market.

Dietmar Falke is Head of Clinical Research at Emergo by UL.

Additional EU MDR and clinical data management resources from Emergo by UL:

• Clinical Evaluation Report (CER) preparation support
• European post-market clinical follow-up (PMCF) study consulting
• Webinar: Optimizing your PMS and clinical activities for MDR compliance