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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