The MDCG has updated a guidance document initially published in 2021 regarding Clinical Investigations. The guidance document is in the form of a Question and Answer and contains a plethora of different questions and answers covering a variety of different scenarios for clinical investigations.
The updated document sees the addition of a number of different questions including:
- Question 2: Is there legislation other than the MDR that needs to be considered when conducting clinical investigations of devices?
- Question 4: Are all clinical studies that involve use of devices considered clinical investigations as defined by the MDR ?
- Question 5: Are all clinical investigations of devices covered by the MDR requirements?
- Question 14: Are clinical studies of combinations of medical devices and medicinal products subject to the MDR requirements for clinical investigations?
- Question 15: Which regulatory pathway shall a sponsor follow in order to conduct a clinical study (investigation) to collect clinical data both for a medicinal product and a device that will be used to administer the medicinal product, but it is not a single integral product?
- Queston 16: Is there a common EU procedure for combined studies with devices and medicinal products?
- Question 17: According to the MDR, are usability tests considered clinical investigations?
- Question 18: May a retrospective clinical study fall under the definition of a clinical investigation?
- Question 25: What documents do I have to submit with an application for a clinical investigation that follows article 62(1) of the MDR?
- Question 26: What documents do I have to submit for a clinical investigation that follows article 74(1) of the MDR?
- Question 27: What documents do I have to submit for a clinical investigation that follows article 82 of the MDR?
- Question 28: What is the expected content of the Investigator’s Brochure (IB)?
- Question 39: When does the sponsor have to notify an early termination of a clinical investigation?
- Question 41: For how long must study documentation be retained?
- Question 43: Is there a template for the mandatory summary of the clinical investigation report referred to in article 77(5) of the MDR?
- Question 44: When will EUDAMED allow applications for clinical investigation?
- Question 48: What is the role and responsibility of the sponsor’s legal representative?
- Question 49: How should a legal representative check the sponsor’s compliance with the MDR?
- Question 50: Would it be sufficient that the legal representative is able to provide documents from the sponsor upon request by authorities?
There have also been some updates in certain questions and answers throughout the guidance document.
Lastly, the guidance document introduced an additional Annex III in which a flowchart has been used to help determine if a combination product study requires an MDR clinical investigation submission?
Clearly an essential document for sponsors but also for those who need to understand which regulatory pathway to follow in order to conduct a clinical investigation.
The guidance document can be accessed using the following link
