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What's new for
Medical Devices in Europe
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 2020 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.
A roadmap to
Understand the new requirements.
A thorough understanding of the new Medical Device Regulation’s requirements is key to produce and sell certified Medical Devices in valuable markets all around the world.
Choose PQE Group 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.
Review and take action.
Take in the new Regulatory Compliance objectives — such as full device traceability, stricter pre-market control, transparency, UDI and clinical evaluation — conduct successful gap assessment, review your technical documentation and register your product, achieving long-term success.
Learn all about the new General Safety & Performance Requirements and set off a life-cycle approach to device management: download PQE Group’s free guide on how to be prepared for EU MDR and start the remediation activities today.
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in achieving Compliance and globally approved products.
Check out our service catalogue and choose the most suitable solution for you.