Legislation

NATIONAL LEGISLATION

THE MDR AND IVDR REGULATIONS

Since 26 May 2017, the European Medical Device Regulations have been in force and apply from

26 May 2021: Regulation (EU) 2017/745 on medical devices (MDR – Medical Device Regulation)

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

26 May 2022: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR – In-Vitro Diagnostic Regulation)

  • Regulation (EU) 2017/746 of the European Parliament 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

EU Regulations have established a more modern and robust regulatory framework to enhance public health protection and the safety of patients and users. Among other changes an implant card and patient information for individuals with an implanted device were introduced, together with the Unique Device Identification (UDI) which enables each product to be traced in the European Database on Medical Devices EUDAMED. Greater emphasis is placed on monitoring the device throughout its entire lifespan and on post-market surveillance.

Both EU Regulations are binding in their entirety and are directly applicable in all EEA member countries. Additional information on the relevant EU Regulations and their impact in the field of medical devices is available at the European Commission’s official website.

On the same page under the GUIDANCE tab, the guidance adopted by the Medical Device Coordination Group (MDCG) that helps stakeholders in implementing both relevant EU Regulations’ provisions can be accessed.

Informative summaries outlining the changes for economic operators and other stakeholders under the MDR and the IVDR are available at the following link.

DIRECTIVES

    • Council Directive 90/385/EEC on active implantable medical devices 
    • Council Directive 93/42/EEC concerning medical devices 
    • Directive 98/79/EC on in vitro diagnostic medical devices 

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