Clinical investigations and the MDR: SAE reporting to Member States

A guidance on safety reporting under the MDR has been developed by the CIE subgroup of the MDCG

Under MDR Article 80, Recording and reporting of adverse events that occur during clinical investigations, paragraph 2 states:

‘The sponsor shall report, without delay to all Member States in which the clinical investigation is being conducted, all of the following by means of the electronic system referred to in Article 73:

(a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;

(b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(c) any new findings in relation to any event referred to in points (a) and (b).’

The need to report only serious adverse events (SAEs) with a causal relationship with the investigational device, comparator or investigation procedure is an important difference from the AIMDD and MDD, which require that all SAEs be immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.

It should also be noted that MDR Article 120(11) states:

‘Clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to 26 May 2021 may continue to be conducted. As of 26 May 2021, however, the reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.’

A guidance on safety reporting under the MDR has been developed by the Clinical Investigation and Evaluation (CIE) subgroup of the Medical Device Coordination Group (MDCG). The CIE assists the MDCG on issues relating to clinical investigation and evaluation of medical devices in accordance with the MDR. The guidance, which is an update on MEDDEV 2.7/3 Rev. 3, addresses various issues including safety reporting of clinical studies that have begun under the Directives, how safety reports should be submitted to National Competent Authorities in the absence of Eudamed, and other issues. The guidance document Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (MDCG 2020-10/1) and Clinical Investigation Summary Safety Report Form v1.0 (MDCG 2020-10/2) are available on the European Commission website.

This is an excerpt from the BSI medical devices white paper: Medical device clinical investigations – What’s new under the MDR? To browse our collection of medical device white papers, please visit the Insight page on the Compliance Navigator website.