Safety reporting in clinical investigations

The Clinical Investigation Plan (CIP) shall describe in detail how the safety of the subjects is to be monitored, and how adverse events are to be registered and reported. 

Any untoward medical occurrences or clinical signs, unintended disease or injury occurring during the clinical investigation shall be documented according to good clinical practice.

The investigator is responsible for documenting and reporting the events to the sponsor.

The sponsor is responsible for reporting any reportable events to the competent authorities. 

Reporting obligations of the sponsor 

The sponsor shall report all of the following without delay to the Norwegian Medical Products Agency (NOMA) cf. MDR Article 80: 

• ​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. 
• 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 findings in relation to any event referred to above. 

Which investigations are subject to safety reporting according to MDCG 2020-10/1? 

Safety reporting is mandatory for all clinical investigations that require application to NOMA (studies covered by MDR Articles 62, 74(2) and 82.  

In addition, serious adverse events occurring during post-market clinical follow up investigations which require notification to NOMA according to MDR article 74 (1) must also be reported, if there is a causal relationship between the serious adverse event and the preceding investigational procedure (see below). Reporting of other incidents shall follow the provisions of vigilance laid down in Articles 87-90. This is the same reporting procedure as that of CE marked devices in normal use. 

For more information regarding safety reporting, please refer to the MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745. 

How to report 

Reportable events must be reported in accordance with Article 80 of the MDR. Reporting must follow current EU guidelines, using the associated reporting form: 

• MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 and

• Appendix: Clinical investigation summary safety report form​

You will find the guidance documents and form on the European Commission website. 

How to submit a report 

All reportable events occurring during a clinical investigation must be reported by email to kki@noma.no​.  

The report must be submitted to all competent authorities in all countries where the investigation is being conducted.  

The principal investigator and the sponsor shall continuously inform each other of reportable events according to ISO 14155:2020 and current Clinical Investigation Plan. ​