IVDR (In Vitro Devices Regulation)
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 of The European Parlıament and of The Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
According to the IVDR; ‘In Vitro Diagnostic Medical Device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software 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, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; which means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
The IVDR has a transition period of five years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new, more stringent requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
EUDAMED Medical Consultancy is always ready to help you manage The In Vitro Devices Regulation (IVDR) implementation and transition processes related to your company and the products you manufacture / import.