Regulation (EU) 2017/746 (IVDR)

Below you can download the EU Regulations and Directives that are relevant for In Vitro Diagnostic Medical Devices.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Current consolidated version: 20 March 2023

Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)

Current consolidated version: 11 Januari 2012

MDCG – EU IVDR guidance documents
The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The MDCG guidance provides information about the provisions that must be addressed for the implementation of the IVDR. While the guidance is not legally binding, it implements Article 105 of the EU MDR intended for the harmonized and effective execution of the regulations.

CE marking

MDCG guidance documents IVDR

Harmonised Standards – EU IVDR
A harmonised standard is a European standard developed by a recognised European Standards Organisation. : CEN, CENELEC, or ETSI. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.

CE marking

Harmonised Standards IVDR

Common Specifications – EU IVDR
Common specifications are a set of technical and/or clinical requirements that provide a means of complying with the legal obligations applicable to a device, process or system. They are used when no harmonised standard is available or the harmonised standard insufficiently covers the requirements. The EU Commission has adopted new common specifications for several types of Class D IVDs, which provide clarity on requirements related to minimum performance characteristics, number of tests per method claimed by the manufacturer, qualification criteria, acceptance criteria and more.