Introduction
Reporting of Serious adverse events is always a very critical part of a Clinical Investigation.
With the implementation of the EU MDR 2017/745 into national law the procedures and requirements for clinical Investigations are now more harmonized for the EU countries.
The MDCG 2020-10/1, and the Excel SAE reporting Form MDCG 2020-10/2 for SAE reporting in Clinical Investigations, provide helpful guidance on requirements, definitions and differences between the different type of Studies, namely: Clinical Investigations per MDR 2017/745 Articles 62 and 74.2, Article 74.1 and Article 82, the latter falling out of scope of the MDR and MDCG, but are covered by the Member States’ national law.
This blog provides you an overview of SAE reporting requirements for Clinical Investigations with Medical Devices as per MDR 2017/745 Articles 62 and 74.2 in Germany.
Reportable events:
MDCG 2020-10/1: 5 Reportable events:
“For the purpose of this guidance and based on the definitions above, the following events are considered reportable events in accordance with MDR Art. 80(2):
- 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).”
Timelines for Investigators and Sponsors
Investigator’s Reporting Responsibility
Germany Investigator’s Reporting Responsibility | |||
MDR Art. | Event Term | Report to | Timeline |
80 (1) a | AE (Art. 2 Number 57) as outlined in CIP | Sponsor / Sponsor Representative | MPDG: § 63 (1) immediately |
80 (1) b | SAE (Art. 2 Number 58) | Sponsor / Sponsor Representative | MDCG 2020-10/1 immediately, but not later than 3 calendar days after investigation site study personnel’s awareness, MPDG: § 63 (1) immediately |
80 (1) c | Device Deficiency (Art. 2 Number 59) with potential to SA(D)E | Sponsor / Sponsor Representative | MDCG 2020-10-1 immediately, but not later than 3 calendar days after investigation site study personnel’s awareness, MPDG: § 63 (2) Immediately |
80 (1) d | any new findings in relation to any event referred to in points (a) | Sponsor / Sponsor Representative | Not specified |
80 (1) d | any new findings in relation to any event referred to in points (b) and (c) | Sponsor / Sponsor Representative | MDCG 2020-10-1 immediately, but not later than 3 calendar days after investigation site study personnel’s awareness |
Sponsor’s Reporting Responsibility
Germany Sponsor’s Reporting Responsibility | |||
MDR Art. | Event Term | Report to | Timeline |
80.1 | AE and SAE to be collected | Germany Competent Authority / EEA Member State Cas / other countries | On request or in Final Report |
80 (2) a | SAEs (Art 2 number 58) where a relationship with the device, comparator, or study procedure cannot be excluded | Germany Competent Authority Single Reporting Form | MDCG 2020-10/1: imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: Immediately, but not later than 2 calendar days after awareness by sponsor Any other reportable events or a new finding/update to it: Immediately, but not later than 7 calendar days MPDG follows MDR/MDCG also for other Studies (Art. 82 MDR)1 |
EEA Member State CAs / other countries MDCG 2020-10/2 | |||
80 (2) b | Device Deficiency with potential to SA(D)E | Germany Competent Authority Single Reporting Form | MDCG 2020-10/1: imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: Immediately, but not later than 2 calendar days after awareness by sponsor Any other reportable events or a new finding/update to it: Immediately, but not later than 7 calendar days MPDG follows MDR/MDCG also for other Studies (Art. 82 MDR) |
EEA Member State CAs / other countries MDCG 2020-10/2 | |||
80 (2) c | any new findings in relation to any event referred to in points (a) and (b) | Germany Competent Authority Single Reporting Form | MDCG 2020-10/1, May 2020: imminent risk of death, serious injury, or serious illness and that requires prompt remedial action for other patients/subjects, users or other persons or a new finding to it: Immediately, but not later than 2 calendar days after awareness by sponsor Any other reportable events or a new finding/update to it: Immediately, but not later than 7 calendar days MPDG follows MDR/MDCG also for other Studies (Art. 82 MDR) |
EEA Member State CAs / other countries MDCG 2020-10/2 | |||
Quarterly SAE assessment
In addition, the German Competent Authority (BfArM) requests a quarterly SAE assessment for all SAEs occurred during the Clinical Investigation.
SAE Summary Evaluation, for ALL SAEs
| Germany Competent Authority (EEA Member State CAs if requested) | Quarterly |
Country specific forms2
- BfArM / PEI form for Reportable Event occurred in Germany to CA in Germany: for Reportable Events related to Investigational Device, Comparator, or Study Procedure (single report)
- Germany: MDCG 2020-10/2 SAE reporting form for, Reportable Events occurred in Germany to report to EU and OEU Member State CAs, and Reportable Events occurred in EU and OEU Member States to report to German CA
- Germany: SAE Summary Evaluation: Evaluation reporting form, Annex 3.1 complication rate
Until EUDAMED is available, All Reportable events as outlined above need to be submitted via email to: MPSAE@bfarm.de
For more information, please reach out to us, or wait for our whitepaper on SAE Reporting in Clinical Investigations as per MDR 2017/745 Art. 62 and 74.2
