MDCG 2020-10/1 Rev. 1 explains how sponsors must report safety events arising during medical device clinical investigations under Article 80 of Regulation (EU) 2017/745. It covers reportable serious adverse events, device deficiencies, new findings, causality assessment, reporting timelines and communication with national competent authorities.
The guidance remains operationally relevant while the EUDAMED Clinical Investigations and Performance Studies module is not yet mandatory. As of July 2026, this module remains under analysis, while the Vigilance and Post-Market Surveillance module is still in development. Sponsors must therefore continue to follow the applicable MDCG guidance and national competent authority procedures for clinical investigation safety reporting.
MDCG 2020-10/1 and MDCG 2020-10/2 at a Glance
| Document | Purpose | What sponsors use it for |
|---|---|---|
| MDCG 2020-10/1 Rev. 1 | Explains the safety reporting requirements and modalities applicable to medical device clinical investigations under the MDR. | Determining which events are reportable, assessing causality, meeting reporting deadlines and submitting updates. |
| MDCG 2020-10/2 | Provides the Clinical Investigation Summary Safety Reporting Form. | Recording new reportable events, updates and final information in the tabular format submitted to competent authorities. |
MDCG 2020-10/1 contains the reporting rules and completion instructions. MDCG 2020-10/2 is the corresponding reporting form. Sponsors generally need both documents to implement the process correctly.
Safety data collected during the investigation must also be accurately reflected in the final study documentation. Our guide to the Medical Device Clinical Investigation Report explains how adverse events, adverse device effects and device deficiencies should be presented in the CIR and its summary.
Which Events Must Be Reported?
Under MDR Article 80(2) and MDCG 2020-10/1 Rev. 1, the sponsor must report:
- Any serious adverse event that has a causal relationship with the investigational device, comparator or investigation procedure, or where such a relationship is reasonably possible.
- 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.
- Any new finding or relevant update concerning a previously reported event or device deficiency.
An SAE assessed as “not related” by both the sponsor and investigator is generally excluded. If either party assigns a causality level above “not related”, the event should be reported.
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
Safety reporting for PMCF investigations depends on the investigation design and the relationship between the event, the device and any additional procedures imposed by the Clinical Investigation Plan.
For PMCF investigations under MDR Article 74(1), the vigilance requirements in Articles 87 to 90 apply to reportable incidents associated with the CE-marked device. However, a serious adverse event causally related to a preceding investigational procedure must also follow the clinical investigation reporting process under Article 80.
A single event may therefore require assessment under both the clinical investigation safety reporting process and the medical device vigilance process. The sponsor should document the applicable pathway, causality assessment, reporting recipients and deadlines in the safety reporting plan.
MDCG 2020-10/1 Reporting Timelines
| Reporting flow | Event | Maximum deadline |
|---|---|---|
| Sponsor to all relevant NCAs | Event indicating an imminent risk of death, serious injury or serious illness that requires prompt remedial action | Immediately, no later than 2 calendar days after sponsor awareness |
| Sponsor to all relevant NCAs | Any other reportable event or new information concerning an existing report | Immediately, no later than 7 calendar days after sponsor awareness |
| Investigator to sponsor | Reportable event identified by investigation-site personnel | Immediately, no later than 3 calendar days after site awareness |
An initial report may contain incomplete information when this is necessary to meet the deadline. The sponsor must subsequently provide updated and complete information.
These reporting requirements should be incorporated into the Clinical Investigation Plan, monitoring procedures, investigator training and safety management process. They should also be applied alongside the Good Clinical Practice requirements discussed in our guide to ISO 14155:2026 for medical device clinical investigations.
FAQs about MDCG 2020-10 Rev 1
MDCG 2020-10/1 Rev. 1 is an MDCG guidance document explaining safety reporting for medical device clinical investigations under MDR Article 80. It covers reportable events, causality assessment, reporting methods, deadlines, PMCF investigations and completion of the summary reporting form.
MDCG 2020-10/1 contains the safety reporting rules, definitions, timelines and completion instructions. MDCG 2020-10/2 is the corresponding Clinical Investigation Summary Safety Reporting Form used to record and communicate reportable events and updates.
The sponsor must report SAEs that are causally or potentially related to the investigational device, comparator or investigation procedure, device deficiencies that might have led to an SAE, and new findings concerning previously reported events. Events assessed as not related by both sponsor and investigator are generally excluded.
Events presenting an imminent risk that requires prompt remedial action must be reported immediately and no later than two calendar days after sponsor awareness. Other reportable events and updates must be reported immediately and no later than seven calendar days. Investigators must report applicable events to the sponsor immediately and no later than three calendar days after site awareness.
It can apply to PMCF investigations, particularly when an SAE is causally related to an additional investigational procedure. Device-related incidents may also need to be processed through the MDR vigilance system. Sponsors must determine whether one or both reporting pathways apply.
MDx CRO supports sponsors with safety management planning, clinical monitoring, competent authority reporting, data management and end-of-study documentation for medical device investigations. Explore our MedTech Clinical Solutions or contact our Clinical Research team to discuss an upcoming or active investigation.
