[PDF] Medical Devices Regulation (MDR) Regulation (EU) 2017/745

Regulation (EU) 2017/745 of the European Parliament and of

Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

Table of Contents European Medical Device Regulation 2017/745

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

AFDO - 2017 2017/745 - Medical Device Regulation (MDR)

Medical Devices Regulation (MDR) Regulation (EU) 2017/745

Medical Devices Regulation (MDR) Regulation (EU) 2017/745 The language in the Regulation suggests a more robust set of Technical Documentation similar to a

IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and

Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This rolling plan contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future This plan is divided into two sections: implementing acts, and other actions/initiatives

THE NEW EU MEDICAL DEVICE REGULATION (MDR): Prac cal Implica

Under the new Regulation 2017/745, device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of potential safety risks Post Market Clinical Follow up (PMCF) is a continuous process with the objective of constantly updating the clinical evaluation (MDR Annex XIV, Part B)