The Competent Authorities for Medical Device (CAMD) has published the objectives of the taskforce for Medical Device Regulation (2017/745 MDR) and In Vitro Diagnostics Regulation (2017/746 IVDR) implementation. The aims of the taskforce are to implement an effective, robust, predictable and secure regulatory system that ensures better protection for public health in the medical devices sector.
The publication consists of a priority list of the key issues to be addressed and a recommendation on where these may best be addressed as part of the implementation of MDR and IVDR. The following topics are those considered in this priority list:
1-Clinical Evaluation and Clinical Investigation (MD); Performance Evaluation and Performance Studies (IVD)
2-Scope and Classification
3-Notified Bodies and Conformity Assessment
4-Post-Market Surveillance and Vigilance for both MD and IVD
5-Eudamed and UDI
6-Market Surveillance
7-IVD-specific issues
8-Over-arching and Cross-cutting priorities
You can find out the whole information in the following link:
Be prepared for the regulation transitional period. If you need support contact us at info@asphalion.com
