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 …

The European Commission published the first Implementing Regulation related to the EU MDR and EU IVDR in the Official Journal of the EU. Regulation (EU) 2017/2185 contains the codes and corresponding types of devices to be used to specify the scope of …

REGUL ATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 Apr il 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)

MDR Guidances and Tools. Download the free MDR Gap Analysis Tools. Check latest MDCG. Check guidance documents from EU and Notified Bodies. Review the list of Meddev Guidances. Reach out for support. Learn more about UDI/EUDAMED. Check …

2021年5月26日 · The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products.

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on …

2024年11月21日 · Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices

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

The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions.

The Medical Device Coordination Group (MDCG) of experts have published guidance on a range of topics including the following: