Amendments to clinical investigations for medical devices

07 July 2009, Updated 17 December 2015

The below table shows examples of the amendments to authorised clinical investigations that must be notified to the Danish Medicines Agency, and which require authorisation from the Danish Medicines Agency.

Examples
Require authorisation by DKMA
Notification
only
Do not submit to DKMA
Changes to the clinical investigation plan
     
Study design
X
   
Purpose of the investigation
X
   
Subject safety
X
   
Number of subjects
X
   
Inclusion/exclusion criteria
X
   
Safety monitoring
X
   
Information sheet & informed consent form
 
X
 
Recruitment procedure
   
X
Measures of efficacy
X
   
Addition or deletion of tests or measurements
X
   
Duration of exposure to the device under investigation
X
   
Extension of the study beyond the period specified in the application form due to a prolonged recruitment period
 
X
 
Design of device under investigation
X
   
Statistical analysis
X
   
Correction of typographical errors in the clinical investigation plan or other study documentation
   
X
Changes to investigation arrangements
     
Investigator’s team, e.g. co-investigator
   
X
Funding arrangements    
X
Recruitment material for subjects
   
X
Insurance or indemnity arrangements for subjects
   
X
Principal investigator at a Danish site
X
   
Coordinating investigator
X
   
Addition of a Danish investigation site
X
   
Removal of Danish investigation sites
 
X
 
Sponsor or sponsor's representative, e.g. CRO
 
X
 
Changes to device under investigation
     
Quality or safety of the device
X
   
Device name or code
 
X
 
Device specifications
X
   
Significant changes in labelling or instructions for use
X
   
Shelf life, storage conditions
X
   
Changes to benefit/risk assessment
     
New test results affecting the assessment
X
   
Results of new clinical investigations or new interpretations of existing data, which affect the assessment
X
   
Investigator's Brochure, if there are significant changes
X
   

We charge a fee for applications for amendments which require authorisation from the Danish Medicines Agency.

Application form for amendments to the clinical investigation.

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