Do you have sufficient clinical evidence for your medical device?

New guidance issued by European Medical Device Coordination Group (MDCG)

Even with the postponement of the date of application for the Medical Devices Regulation (MDR) to 26 May 2021, manufacturers still need to pay attention to ensuring that they have sufficient clinical evidence for their devices that they intend to transition to the MDR. The Medical Device Coordination Group (MDCG), which is composed of representatives of Member States and chaired by the EU Commission, has issued four further guidance documents on clinical investigation and evaluation. It should be emphasised that the documents were issued prior to the postponement of the date of application of the MDR. As with all the MDCG guidance, it cannot be regarded as reflecting the official position of the European Commission, or as being legally binding.

The four documents add to the guidance on the summary of safety and clinical performance and provide guidance for manufacturers and notified bodies on:

• Clinical Evaluation – Equivalence - MDCG 2020-5;
• Sufficient Clinical Evidence for Legacy Devices - MDCG 2020-6;
• Post-market Clinical Follow-up (PMCF) Plan Template MDCG 2020-7;
• PMCF Evaluation Report Template - MDCG 2020-8.

The guidance on clinical evaluation - Equivalence – covers demonstrating equivalence of data for a device on the market for CE-marking under the MDR. The purposes of the document are to:

• highlight the differences between the MDR and the MEDDEV 2.7/1 rev.4  - Guidelines on medical devices, clinical evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC - with regards to equivalence.
• provide additional guidance and support for a harmonised approach to the demonstration of equivalence across the EU.

The guidance on sufficient clinical evidence for legacy devices aims to assist manufacturers and notified bodies to prepare for the conformity assessment procedure according to the MDR. Special attention is given to class III and implantable devices that are exempt from the requirement to conduct a clinical investigation because they have been previously CE-marked under the Directives or have been demonstrated as equivalent to such previously CE-marked devices.

Two further documents provide templates for PMCF plans and reports. The MDR considers PMCF as a continuous process that updates the clinical evaluation. PMCF is addressed in the manufacturer’s post-market surveillance (PMS) plan but the MDR provides requirements specific for a PMCF plan detailing the methods and procedures proactively to collect and evaluate clinical data from the use of CE-marked devices. The findings from PMCF are analysed by the manufacturer and the results are documented in a PMCF evaluation report. This PMCF evaluation report is part of the clinical evaluation report and the technical documentation. The adequacy of the PMCF plan and its application is assessed by the notified body; therefore, the notified body’s assessment of the clinical evaluation also covers the procedures and documentation of the PMCF.

One of the major differences between the MDR and the medical devices Directives is the requirements for clinical evidence. Although these documents are not legally binding, they provide important interpretations of the expectations of competent authorities and the European Commission in respect of several key aspects of the requirements for clinical evidence. Manufacturers should review these documents along with the clinical evidence that supports conformance of their devices with the MDR.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development