Source: https://ce-marking.help/directive/medical-devices
Timestamp: 2019-07-18 06:29:36
Document Index: 397231827

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 2', 'art 3']

Medical devices directive - CE Marking assistant
Home Medical devices Directive (93/42/EEC)
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. Both medical devices and accessories shall hereinafter be termed devices.
— control of. conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.
In 2017 a new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices has been published in the Official Journal of the European Union on 5 May 2017, 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. At the same time also a Regulation (EU) 2017/746 on in vitro diagnostic medical devices, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, has been published.
EN 285:2006 +A2:2009 Sterilization - Steam sterilizers - Large sterilizers
EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
EN 455-2:2009 +A2:2013 Medical gloves for single use - Part 2: Requirements and testing for physical properties
EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 794-3:1998 +A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
EN 455-2:2009 +A2:2013
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...