Category: Medical Device Regulation MDR

Grey literature and medical devices

Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual […]

Creating a post market surveillance (PMS) system for medical devices – Part 1

Another series, initiated in a Linkedin post. The PMS process is nothing more than a research project focused on answering specific questions related to the product, with the objective of defining actions based on the research results. To do so, it must be planned and designed as a research project, with fundamental questions that the […]

EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents

EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 Manufacturer incident report Helptext 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020

EU – Some documents related to Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices

Application form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Procedural guidance on declaration of interests – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Declarations on confidentiality and commitment – Call […]