TEAM NB Release Template for the Agreement Related to the Transfer of IVDR Formal Application and of Appropriate Surveillance of Legacy Devices
Team-NB members adopted, a template Agreement form related to the transfer of IVDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer in respect of legacy devices covered by Directives certificates. The full template can be accessed using the following link
New MIR Form Template to become mandatory as from 1st of May 2026
The EU Commission has announced the date which the new MIR Form Template will be made mandatory. The date has been set for 1st May 2026, after which, the old MIR form template will not be accepted by competent authorities and notified bodies. To offer some background to this update, the European Commission has released ...
Self-Declaration Template has been Published by the MED-TECH
Persuant to question 5 of the Q&A released by the EU Commission, manufacturers need to demonstarte that the conditions for the extension are fulfilled by means of a self-declaration, similar to the form produced for the MDR extension. The self-declaration should also state the end date of the transition peroid and should clearly identify the ...
