In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system referenced in Article 73 (Eudamed), the MDCG 2020-10 Rev 1 provides essential guidance. With Eudamed not being ready on the MDR’s effective date, the guidelines under MDCG 2020-10 Rev 1 become instrumental in outlining the processes for safety reporting in clinical research.
Medical device safety reporting in clinical studies with medical devices must follow the guidelines in Article 80 of Regulation (EU) 2017/745, Medical Device Regulation (MDR).
Key Points from MDCG 2020-10 Rev 1:
- Safety Reporting Modalities: The document thoroughly describes the reporting modalities for Serious Adverse Events (SAEs) and offers a summary tabulation reporting format.
- Adherence to Regulations: It emphasizes that medical device safety reporting during clinical studies must be consistent with the guidelines in Article 80 of Regulation (EU) 2017/745, also known as the Medical Device Regulation (MDR).
For a clinical investigation involving medical technology, utilizing the electronic system as stipulated in MDR Article 73 means the sponsor must promptly share the following with every Member State involved:
- Any SAE that can be directly or potentially linked to the investigational device, comparator, or the procedure.
- Any device defect that could have escalated to a serious adverse event under different circumstances.
- Further details on any aforementioned event.
The timeframe set for reporting these adverse events varies based on the severity of the incident. While the clinical trial sponsor might initially provide an incomplete report, it’s crucial to follow up with a detailed one to maintain timely reporting.
The guidance not only covers the basic safety reporting protocols but also delves deeper into the post-market clinical follow-up (PMCF) investigations for CE-marked MedTech products. Here, the guidelines laid out in MDR Articles 87 to 90 play a pivotal role.
Safety Reporting in PMCF Clinical Investigations
It’s noteworthy that while the vigilance measures outlined in the aforementioned articles are applicable to PMCF clinical studies, the MDCG 2020-10 Revision 1 remains relevant. This is primarily because the reporting of significant adverse events linked to previous investigational devices should align with the reporting prerequisites mentioned in EU MDR 2017/745 Article 80.
The guidance document provides an essential roadmap for Safety reporting SOPs, Safety reporting plans, and Clinical Investigation plans. This is invaluable for MedTech Manufacturers, sponsors, and CROs involved in clinical research activities with medical devices.
FAQs about MDCG 2020-10 Rev 1
- What events need reporting? Report all SAEs and suspected unexpected serious adverse device effects (SUSADEs).
- What’s the reporting timeframe? Report SAEs within 15 days and SUSADEs within 7 days post the sponsor’s awareness.
- What should a safety report include? Details about the sponsor, investigator, device, event date, event description, outcome, and other pertinent data.
For more comprehensive insights on safety reporting for medical devices, delve into the MDCG 2020-10 Rev 1 guidance document.
MDCG 2020-10 Revision 1 provides the guidelines required for the establishment of Safety reporting SOPs, Safety reporting plans, and Clinical Investigation plans for MedTech Manufacturers, sponsors and CROS that develop clinical research activities with medical devices.
