Safety reporting for clinical investigations under the EU Medical Device Regulation

What to report?

MDR Article 80 (2) lists events that shall be reported while conducting a clinical investigation:

1. Any SAE with a causal relationship with the investigational device, the comparator or the investigational procedure or where such causal relationship is reasonably possible.
2.  Any device deficiency that might have led to a SAE event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate.
3.  Any new findings in relation to any event referred to the previous points.

To shed further light on the causal relationship of the event with the procedure or device, MDCG 2020-10/1 defines how to classify SAE according to four levels of causality.

• Not related.
• Possible: weak relation but cannot be ruled out completely.
• Probable: relevant relation that cannot be reasonably explained by another cause.
• Causal relationship: relation beyond a reasonable doubt.

Hence, sponsors are expected to report any possible, probable and causal SAE related to the investigational device or procedure. Note that when the level of causality is uncertain, the sponsor should not exclude the relatedness and the event should be classified as “possible”.

Please note that post-market clinical follow up (PMCF) investigations of CE-marked devices used within the intended use covered by the CE-marking should follow the vigilance reporting mechanisms.

To whom? When?

Reportable events must be reported to National Competent Authorities (NCA). The list and contact of such operating NCAs can be found on the Commission’s homepage and the following link. Additionally, member states may also require separate reporting to the ethics committee(s). 

Regarding timelines, investigators must report to sponsors immediately, and no later than 3 calendar days after investigation site study personnel’s awareness of the event. Sponsor, on the other hand, and depending on the category of the clinical study and the severeness of the adverse event, must follow the reporting timelines as follows:

Additionally, note that in observational studies where the standard of care is kept, only non-expected side-effects that are not documented in the product information and quantified in the technical documentation shall be reported according to the surveillance/ vigilance plan.

How can AKRN support you?

AKRN’s clinical team has thorough expertise in designing, conducting, recording, and reporting clinical investigations, including safety reporting following MDR requirements. Please do not hesitate to contact us for further information regarding clinical investigations support for medical devices.