Safety reporting under MDR in The Netherlands part I

In this video, the following question is briefly answered:

“Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the MDR?”

Transcript:

In today’s video, the following question is briefly answered:

“Which clinical studies in The Netherlands must comply with the safety reporting under article 80 of the MDR?”

With the MDR being applicable as of 26^th of May 2021, each regulatory framework of clinical investigations has different requirements for safety reporting.

No transitional arrangement has been established for safety reports of studies with a positive decision prior to the 26^th of May 2021. This means that the safety reports of certain studies approved prior to this date must also fulfil the safety reporting requirements of article 80 of the MDR.

These studies are:

1. Clinical investigations in the context of conformity purposes.
2. Post-market clinical follow-up investigations where serious adverse events related to the investigational procedure occurred.
3. And studies with a positive decision prior to 26^th of May 2021 and with the obligation to notify the IGJ/CCMO, with the exception of studies that are subject to MDR article 82.