Germany: Federal Institute for Drugs and Medical Devices updates vigilance forms
The Federal Institute for Drugs and Medical Devices (BfArM) has adopted the updated report forms according to MEDDEV 2.12/1 on its website and announced that their use is mandatory as of 1st January 2020. A help text on this topic has also been made available. All forms are currently available in English.
Manufacturers can already use the new form to report incidents. On 31st December 2019, the authority will then withdraw the previous forms. The new form already includes fields that will only become relevant when the EU Regulation on Medical Devices 2017/745 comes into force (e.g. manufacturer's SRN and product UDI). It also introduces codes for the incidents, examination and consequences in accordance with the specifications set out by the IMDRF. Information on this topic can also be found in the published help text.