You are here: Home -> New Approach European Directives -> Medical devices
Medical devices










- 98/79/EC
- 2000/70/EC
- 2001/104/EC
- EC Regulation No. 1882/2003

- 2007/47/EC

Entry into force:  01/16/2007
- For 93/42 /EEC - 07/12/1993
- For 2007/47/EC - 10/11/2007




- RD 414/1996
- RD 2727/1998
- RD 1372/2004
- RD 1143/2007
- RD 1591/2009 (Repeals the RD 414/1996)

Related acts

 - 2003/12/EC 
 - 2003/32/EC 
 - 2005/50/EC 




This Directive shall apply to medical devices and their accessories:

(a) Medical device: any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper application intended by the
manufacturer to be used for human beings for the purpose of:

- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- 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;

(b) Accessory: an article which whilst not being a device is intended specifically by its manufacturer
to be used together with a device to enable it to be used in accordance with the use of the device intended
by the manufacturer of the device.



This Directive does not apply to:

  • in vitro diagnostic devices;

  • active implantable devices covered by Directive 90/385/EEC;

  • medicinal products covered by Directive 65/65/EEC;

  • cosmetic products covered by Directive 76/768/EEC (18);

  • human blood, human blood products, human plasma or blood cells of human origin or to devices
    whichincorporate at the time of placing on the market such blood products, plasma or cells;

  • transplants or tissues or cells of human origin nor to products incorporating or derived from
    tissues or cells of human origin;

  • transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal
    tissue which is rendered non-viable or non-viable products derived from animal tissue