COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices. THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European …

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 …

The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the …

2007年10月11日 · This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right.

2020年11月24日 · See how EU MDD and MDR compare, what is the transition period, and what are the main similarities and differences you should be aware of.

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal …

2022年6月17日 · The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been set back one year to May 26, 2021. The amending EU-MDR Regulation 2020/561 …

The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. The MDD is based on the principles of the “New Approach to …

4 天之前 · However, transition periods are in place, during which time devices that are authorized under the MDD/AIMDD and IVDD can continue to be placed on the EU market. Due to delays, …

Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017. Read the press release from the European Commission.