ECEndOfTrial object
End of trial Declaration mandatory
Yes
Regular Termination - Declaration timespan (max nr days)
Not specified
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Applicable national legal framework/ Reference
Art 54 (2) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl)
Additional Information
Premature termination of the clinical investigation: The sponsor shall also notify the relevant bodies of the Member State and the European Commission if the investigation has been early terminated due to safety considerations.
