Category: Medical Devices Directive – MDD

How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities

So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to perform a clinical evaluation. I notice that a lot of people does not seem to not that a clinical evaluation is nothing more than a specific application of a systematic […]

Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD)

Manufacturers with CE Marking shall update their procedures and forms. Fabricantes com Marcação CE devem atualizar seus procedimentos e formulários. Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) New Manufacturer Incident Report helptext.

Medical Device Directives – New templates for Field Safety Notices published

The EU Commission published some new templates for Field Safety Notices related to the current medical device directives and MEDDEV 2.12/1 rev.8. template links are below (they can also be found at: https://ec.europa.eu/growth/sectors/medical-devices/guidance_en). A Comissão da UE publicou alguns novos modelos para Avisos de Segurança de Campo relacionados às diretivas atuais de dispositivos médicos e ao MEDDEV 2.12 […]