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MDCG offers guidance on clinical investigations under MDR

Posted 27 April 2021 | By Michael Mezher 

MDCG offers guidance on clinical investigations under MDR

In new questions and answers guidance released last week, the European Commission’s Medical Device Coordination Group (MDCG) offers advice to device makers on the appropriate regulatory pathways and other considerations for conducting clinical investigations under the Medical Device Regulation (MDR).
 
The 19-page document features 28 questions and answers as well as two annexes charting the regulatory pathways for clinical investigations and a non-exhaustive list of modifications of clinical investigations that may be interpreted as substantial.
 
The guidance addresses questions covering a range of issues, including the appropriate regulatory pathway for clinical investigations under different circumstances, modifications to clinical investigations, timeline considerations, clinical investigation reports and how sponsors of clinical investigations should handle certain issues following the MDR transition period.
 
For sponsors of clinical investigations, the guidance explains which regulatory pathway to follow for different types of clinical investigations, including pilot clinical investigations (i.e. first in human trials or early feasibility studies) or clinical investigations of devices that are already CE marked. The guidance also discusses the notification and safety reporting requirements for clinical investigations and specific considerations for devices without a medical purpose and custom-made or in-house manufactured devices.
 
The guidance also provides an overview of modifications to clinical investigations, defining substantial modifications and discussing when notification should be submitted for such modifications.
 
Additionally, the guidance offers input on clinical investigation timelines, including on the start and end dates of studies, notification requirements for when a study is concluded and when the summary of results from a clinical investigation should be submitted to the member states in which the investigation was conducted.
 
As the clinical investigation module in Eudamed will not be ready by 26 May 2021, the date of application for MDR, “All requested information to apply for or notify a clinical investigation should be submitted to the national competent authorities unless otherwise specified in the [member state] concerned.” Clinical investigations already underway by the date of application of MDR can continue, though serious adverse events and device deficiencies that occur after the date of application should be notified to the member state according to Article 80 of MDR.
 
MDCG also posted a revision to its guidance on BASIC unique device identifier-device identifier (UDI-DI) and changes to UDI-DI. The revision includes a discussion of how devices with an established maximum number of reuses are handled in the UDI Database in Eudamed and explains that a change to the maximum number of reuses data element would require the allocation of a new UDI-DI.
 
MDCG

 

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