By 25 May 2017 the new EU Medical Device Directive 2017/745/EU (MDR) enters into force and replaces the existing Council Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD). The new regulations will …
The MDR 2017 – the most important changes
With the release of the new European Regulation on medical devices (EU) 2017/745 the manufacturers must expect new requirements. EU Medical Device Regulation The most important changes are: higher requirements for …
Clinical Evaluation according to MEDDEV 2.7.1 Rev.3
First of all it should be clarified that the regulatory framework for clinical evaluation is determined by the directive 93/42/EEC (amended by the directive 2007/47/EC). The guideline MEDDEV 2.7.1 helps …