European Union: EU Medical Devices Regulation: Adoption Of Further Guidance Documents

In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021.

Despite the summer break and the difficulties caused by the pandemic, the Medical Device Coordination Group (MDCG) and the European Commission have endorsed a number of significant guidance documents relevant for manufacturers, national authorities, notified bodies and expert panels. In addition, the fourth implementing act, required by the MDR, has been adopted by the European Commission.

New Implementing Regulation

The expected Implementing Regulation on the common specifications (CS) for the reprocessing of single-use devices was adopted on 19 August 2020. As a reminder, the MDR defines CS as "a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system". The Implementing Regulation is relevant in those EU Member States where reprocessing of single-use devices is allowed under national law and takes place within health institutions. In these circumstances, EU Member States can decide not to apply all of the rules relating to the obligations for manufacturers, provided that reprocessing is performed in accordance with CS.

The CS introduced by the Implementing Regulation address requirements concerning risk management, validation procedures, product release, quality management systems, audits, reporting of incidents and traceability. The Implementing Regulation will apply on the same date as the MDR, i.e., 26 May 2021.

New Guidance

Eudamed actor registration module

The MDCG has published a position paper on the use of the Eudamed actor registration module and of the Single Registration Number (SRN) in the EU Member States. Eudamed is expected to be fully operational as of May 2022, although the MDCG has indicated that each Eudamed module will be deployed as soon as it is operational. The actor registration module is scheduled to be the first module available, expected on 1 December 2020. In order to avoid double registration requirements, the MDCG strongly encourages the use of the actor registration module by all relevant actors in their respective territories.

Clinical evaluation

The MDCG has published a template for the clinical evaluation assessment report (CEAR). Under the MDR, notified bodies are required to review and document in the CEAR the clinical evidence presented by the manufacturer in the clinical evaluation report, and details of the clinical evaluation conducted. The MDCG's template provides "a standardised method for documenting the notified body's assessment of the manufacturer's clinical evaluation and related documents". The template contains explanatory texts under each heading, with brief descriptions of the type of information that should be documented by the notified body. It is also important for manufacturers, as it sets out what information will be scrutinised by their notified body during the assessment procedure.

MDSAP audit reports

A new MDCG document provides guidance to notified bodies on what weight to place on audit reports issued by Medical Device Single Audit Program (MDSAP) auditing organisations when notified bodies perform surveillance audit activities under the MDR. The guidance document provides that the use of MDSAP audit reports will be possible only when covering similar or equivalent MDR requirements. In particular, MDSAP audit reports may help to identify key points under the MDR surveillance audit or may require the notified body to pay particular attention to potential non-conformities identified by the MDSAP audit reports. The MDCG guidance clarifies, however, that notified bodies cannot make use of the MDSAP audit reports for initial quality management system audits and that MDSAP unannounced or special audits cannot be taken into consideration.

New guidance for expert panels

The European Commission has published a document intended to provide guidance to expert panels, established by the MDR, when deciding to provide or refuse to provide a scientific opinion on the CEAR of the notified body. For certain high-risk devices, the MDR requires notified bodies to request scrutiny of the CEAR by an expert panel. The present document provides the necessary guidelines on how the panel should assess the novelty of a device and its clinical and health impact, or any scientifically valid health concerns or significantly increased rate of serious incidents.

Going forward, companies should continue to assess their readiness to meet the MDR requirements and decide between applying for an MDD or an MDR certificate. In addition to this, companies should also take into consideration other factors such as notified bodies capacity, availability of essential guidance documents, access to expert panels' consultation procedures and other factors specific to the type of their medical devices. Our team can advise on compliance strategies and help with the decisions that need to be taken under the evolving circumstances.

Originally published by Arnold & Porter, September 2020

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