scope:

Clinical investigations of medical devices

The reporting modalities and format set out in this guidance apply to:

• Pre-market clinical investigations covered by Articles 62 and 74(2) of the MDR conducted with:

a) Non-CE marked devices,

b) CE marked devices used outside the intended use(s) covered by the CE-marking.

c) The term pre-market clinical investigation may also include some studies covered by MDR Article 82.

As MDR Article 82 allows member states to define national requirements for such clinical investigations, sponsors are encouraged to check with the applicable NCA² whether this guidance or other reporting procedures should be applied.

In situations where a clinical investigation has started using a non-CE marked device, and the right to bear the CE marking has been obtained before the end of the clinical investigation, the SAE reporting continues until completion of the investigation, according to the clinical investigation plan and these guidelines apply throughout the SAE reporting period.

For pre-market clinical investigations involving CE marked comparator devices used within their intended purpose, SAEs occurring in or to subjects that are in the comparator arm of an investigation shall also be reported in accordance with these guidelines.

Note: SAEs concerning CE marked devices which meet the vigilance reporting criteria also need to be handled under the post-market surveillance/vigilance system.

• Those Post-Market Clinical Follow Up (PMCF) investigations that involve procedures additional to those performed under the normal conditions of use of the device, and where those additional procedures imposed by the clinical investigation plan are invasive or burdensome, covered by MDR Article 74(1). For these clinical investigations the safety reporting for events pertaining to MDR Article 80(6) follow the Serious Adverse Event reporting process only, and are outlined in this guidance. Events pertaining to MDR Article 80(5) are reported following the vigilance process only and are outside the scope of this guidance.

• Note that other post-market clinical investigations may be subject to safety reporting requirements in line with this guidance due to national requirements following MDR Article 82, but there is no such general requirement. Sponsors are encouraged to check with the applicable NCA whether this guidance or other reporting procedures should be applied.

• Due to the transitional provisions in MDR Article 120(11) this guidance also covers clinical investigations which have started to be conducted in accordance with Article 10 of Directive 90/385/EEC (AIMDD) or Article 15 of Directive 93/42/EEC (MDD) prior to 26 May 2021. These investigations may continue to be conducted after date of application of the MDR, but the reporting of serious adverse events and device deficiencies shall be carried out in accordance with the MDR requirements from 26 May 2021 and onwards.

Medical devices used in clinical trials of medicinal products (drug trials)

• A CE-marked device which is used outside its intended purpose, or a non-CE marked device in a clinical drug trial would implicitly have to be assessed for safety and performance and the study shall follow both MDR (Chapter VI) and the applicable legislation for clinical drug trials. This guidance document is then relevant for compliance with the MDR regarding safety reporting.

• If a drug-device study (or a drug trial) is not undertaken to assess the safety or performance of a device used in the study, the reporting requirements of MDR Article 80 do not apply, as long as the device is CE marked and used within its intended purpose. This guidance is not applicable, but the vigilance reporting provisions of MDR apply in those situations, as for any commercially available device. Sponsors should make sure that the device manufacturer is notified about any incidents related to the device and the legal manufacturer of the device is responsible for the subsequent vigilance reporting.

² For the purpose of this guidance," NCAs" encompasses the National Competent Authorities of the EEA, Switzerland and Turkey.