A roadmap to regulatory compliance to register your product and safely sell in Europe.
A thorough understanding of the new Medical Device and IVD Regulation’s requirements is key to produce and sell certified Medical Devices and IVD in valuable markets all around the world.
Choose us as your experienced and certified partner and join the Q&A Section on EU MDR with our Compliance and RA Director Luisa Cabria, to learn how to effectively implement a Compliant Quality Management System.
With its 123 articles, 10 chapters and 17 annexes, EU MDR 2017/745 is a fundamental revision of the European regulatory framework that aims at ensuring the quality and safety of Medical Devices being produced or supplied into Europe. The new set of requirements includes a reinforcement of the existing rules and criteria, a wider definition of a Medical Device, and the introduction of Economic Operators as a target of the new regulation.
The changes from the current Medical Device Directive may be seen as a mere revision, but are to be considered as a whole new legislation that will enter into force on May 2021 and will be relevant to any company that wishes to produce or supply MD in Europe, from start-up business that intend to reduce time-to-market, to already established organizations that want to secure business continuity and effectively manage the transition timeline.
From Data Integrity to CE Marking, PQE Group assists clients from all Lifescience industries in achieving Compliance and globally approved products.