You are here: Home -> New Approach European Directives -> In vitro diagnostic medical devices
In vitro diagnostic medical devices





D.C. 98/79/EC +            2011/100/EU





- Reglamento CE Nº 1882/2003

Entry into force: 
- Directive 98/79/EC: 12 july 1998

- Directive 2011/100/EU: 7 january 2012



RD 1662/2000
RD 1143/2007 (Amendment to Articles 4.1, 18 and 18bis add)
RD 1591/2009 (Amendment of Articles 13 and 25)
RD 109/2010 (Amendment to Article 13.2

RD 1193/2012



This Directive shall apply to in vitro diagnostic medical devices and their accessories.

‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent
product, calibrator, control material, kit, instrument, apparatus, equipment, or system,
whether used alone or in combination, intended by the manufacturer to be used in vitro for
the examination of specimens, including blood and tissue donations, derived from the human body:

  • concerning a physiological or pathological state

  • concerning a congenital abnormality

  • to determine the safety and compatibility with potential recipients

  • to monitor therapeutic measures


This Directive shall not apply to:

  • invasive sampling devices or those which are directly applied to the human body for the
    purpose of obtaining a specimen within the meaning of Directive 93/42/EEC.

  • devices manufactured and used only within the same health institution and on the premises
    of their manufacture or used on premises in the immediate vicinity without having been
    transferred to another legal entity.