The Medical Device Coordination Group (MDCG) has issued a new guidance on clinical investigations under the Medical Devices Regulation 2017/745 (MDR). In this sense, it addresses the case of a substantial change to a clinical investigation. Therefore, sponsors intending to introduce modifications to a clinical investigation that have a substantial impact on:
-
- Safety
- Health
- Rights of the subjects of the clinical investigation
- Robustness or reliability of the clinical data generated by the clinical investigation
need to notify the Competent Authority of the country where the clinical investigation is being conducted though the electronic system, in a deadline of one week.
Additional documents on clinical investigation application and notifications are provided though the MDCG’s guidances 2021-8 (on clinical investigation/application documents) and 2021-20 (on generating CIV-ID) in view of the absence of EUDAMED.
Moreover, this guidance provides a template for the notification of clinical investigations, mimicking the data fields of the EUDAMED system currently under development. Finally, it is recommended by the guidance to check for specific national requirements of the country in where the clinical investigation is placed.
Please also be aware that the template will not be needed once the corresponding EUDAMED module is fully functional.
You can find the Guidance as well as other MDCG endorsed documents in our dedicated Library!
Leave a Reply