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 26th 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 26th 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 26th of May 2021 and with the obligation to notify the IGJ/CCMO, with the exception of studies that are subject to MDR article 82.

Share This Post

Other articles

Clinical Investigations

What has changed in the new ISO14155:2020 standard?

The ISO14155 provides an important guide on the use of Good Clinical Practice in clinical investigations. In the ISO14155 you’ll find the main requirements to: protect the well-being, safety and rights of human subjects in the clinical investigation; assure the scientific relevance of the investigation and the trustworthiness of its results; define what the sponsor

Video

Harmonization EC approval process

In today’s video, I will briefly answer the following question:   “How is the approval process of Ethics Committees harmonized under the MDR?”      Transcript:   Ethics committees are responsible for evaluating a clinical investigation and determine whether ethical principles are being met. Requirements related to ethics committee composition and function are not specified in the

Scroll naar top