Device Studies and MDCG Guidance on Safety Reporting

Clinical investigations are fundamental to medical devices for safety & performance assessments during Regulatory submissions. Emphasizing the significance of how safety reporting in clinical investigations of medical devices should be performed, the European Commission’s Medical Device Coordination Group (MDCG) devised new guidance under Medical Devices Regulation (MDR).

Due to unavailability of a fully functional electronic system referred to in the Article 73 (EUDAMED), at the date of application of MDR, this guidance outlines the procedures for safety reporting in clinical investigations. As per the electronic system referred to in the Article 73, the sponsors must report  following information about the clinical investigation to all the Member States.

  • Any Serious Adverse Event (SAE) having a causal relationship with the investigational device, the comparator, or the investigation procedure
  • Any device deficiency that might have led to an SAE
  • Any new findings in relation to any event referred to SAE & device deficiency

The guidance has reporting modalities which apply to pre-marketing clinical investigations of non-CE marked devices and CE marked devices used outside their intended uses and device studies covered under the MDR Article 82. When a clinical investigation for a non-CE marked device starts with a CE marking obtainment before the end of an investigation, the SAE reporting will continue until the investigation completes. For clinical investigations of 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.

Certain Post-Market Clinical Follow-Up (PMCF) investigations are also applicable to follow these guidelines. They involve procedures additional to those performed under the normal conditions of device usage, and where those additional procedures imposed by the clinical investigation plan are invasive or burdensome. Though not a general requirement, some other post-market clinical investigations may be subjected to safety reporting requirements in line with this guidance. For both pre- and post-market clinical investigations, sponsors are encouraged to check with the applicable NCA (National Competent Authority) to determine what kind of reporting procedures should be applied.

Trials initiated under the Active Implantable Medical Devices Directive and the Medical Devices Directive apply these guidelines. As MDCH states, these investigations may continue to be conducted after the 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. A new summary reporting form should be used for reportable events and new findings or updates to already reported events, from the date of application of the MDR, i.e., 26 May 2021.

The guidance is relevant to medical devices used in clinical trials for medicinal products, only if undertaken to assess the safety or performance of a CE-marked device and its intended purpose. Where the safety and performance assessments are not studied, the guidance is not applicable.         

As and when EUDAMED is available and fully functional in 6 months after the date of publication of the notice referred to in Article 34(3) of the MDR, the safety reporting should be carried out via EUDAMED. During this transition, sponsors should continue to submit the follow-up and final reports to the national competent authorities using the same procedure as for the initial reports, and all new reportable events should be submitted to EUDAMED.  

Quoting the above information, the market entrants should effectively maintain their clinical data as per the updated regulations to streamline their safety reporting. Whether it is accurate maintenance of data or clear-cut Regulatory strategies for medical devices aligning with the EU MDR, it is necessary for manufacturers to follow the best practices to evade any last-minute challenges. Consult a Regulatory expert. Stay safe. Stay informed. Stay compliant.