CE Marking - What is the Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) is a new regulation governing the safety of medical devices available in the European Union (EU).
Work on the new MDR began in 2012 following the Poly Implant Prothèse (PIP) breast implants scandal.
The new Medical Device Regulation was published on 5 May 2017 by the Official Journal of the European Union. This new regulation – known as (EU) 2017/745 – replaces and repeals both the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC.
More information is in this datasheet ►
ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes)
ISO 13485 is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices service providers, including manufacturers of materials or component parts that are used in medical devices.
Download the full datasheet to gain more insights ►