New template for Field Safety Notice is published at the Commission website
Posted on 06.12.2018
New Field Safety Notice form (to be used only with communication with health care professionals), customer and distributor/importer reply forms and Q&A have been posted to the European Commission’s website here: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en
• Field Safety Notice Template
• FSN Customer reply
• FSN Distributor/Importer reply
• FSN Q&A
Although the FSN form is not mandatory to use ““industry is strongly encouraged to use this form whenever possible in the interests of consistency to help the user” as stated in the connected Q&A document.