Scope

Devices falling under the In-Vitro Diagnostic Medical Device  Regulation (IVDR) 2017/746 are  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; ‘medical device’ means ‘medical device’ as defined in point (1)  of Article 2 of Regulation (EU) 2017/745.

The following products are excluded from the IVDR scope:

• products  for general laboratory use or research-use only products, unless such  products, in view of their characteristics, are specifically intended by  their manufacturer to be used for in vitro diagnostic examination;
• invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;
• internationally certified reference materials;
• materials used for external quality assessment schemes.

Learn More:

• The Regulation: IVDR 2017/746/EU
• Classification
• Technical Documentation
• Path to EU Market Entry: Conformity Assessment Procedures
• Notified Bodies under the IVDR
• Authorized Representatives under the IVDR
• Clinical Evidence and Performance Evaluation
• Clinical Performance Studies
• Person Responsible for Regulatory Compliance

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