IMDRF publishes guidance documents on personalized medical devices for comment
5 December 2022
In October 2022, the Medical Device Coordination Group (MDCG) published a revised version of the MDCG 2020-10/1 “Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745” adopted in May 2020. The revision includes, among other things, new definitions, clarification on filling in the reporting table and reporting duties for safety reporting in clinical investigations of medical devices.
Safety reporting in clinical investigations of medical devices shall be performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR) Article 80(2):
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 MDR 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 period for reporting shall take account of the severity of the event. Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
Upon request by any Member State where the clinical investigation is being conducted, the sponsor shall provide all information referred to in paragraph 1.
Reporting requirements of MDR Article 80(5) and (6) apply for post-market clinical follow up (PMCF) investigations of CE-marked devices1 applied within the intended use covered by the CE-marking. This means that the vigilance provisions laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply for PMCF clinical investigations. However, the guidance document MDCG 2020-10/1 Rev 1 is also relevant for PMCF clinical investigations as the reporting of serious adverse events where a causal relationship to the preceding investigation procedure has been established shall follow the reporting procedures of clinical investigations as outlined in Article 80.
With the electronic system Eudamed, referred to in Article 73, being not available and fully functional at the date of application of the MDR, the guidance “Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745” outlines the procedures for safety reporting in clinical investigations in the absence of Eudamed.
This MDCG guidance document defines Serious Adverse Event (SAE) reporting modalities and includes a summary tabulation reporting format.