The new MDR and IVDR regulations

Regulation in the field of medical devices

On 5 April 2017, the European Parliament adopted two new regulations on medical devices that entered into force on 26 May 2017.

REGULATION (EU) 2017/745 ON MEDICAL DEVICES (MDR – MEDICAL DEVICE REGULATION)

On 26 May 2021, the Regulation (EU) 2017/745 on medical devices (MDR) became applicable regarding the placing on the market or putting into service of medical devices, their accessories and products without an intended medical purpose listed in Annex XVI of the Regulation (EU) 2017/745, regulating the whole medical devices market, including economic operators in this field and healthcare institutions. It is the main legislation regulating the field of medical devices. This regulation also applies for clinical trials with medical devices.

LEGAL BASIS:

Publication of the MDR in the Official Journal of the European Union: 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 [ENG]

Corrigenda and an amendment of the regulation were adopted and published that pushed back the regulation’s application to 2021:
TIMEFRAME FOR THE TRANSITION FROM THE DIRECTIVES TO THE REGULATION ON MEDICAL DEVICES

REGULATION (EU) 2017/746 ON IN VITRO DIAGNOSTIC MEDICAL DEVICES (IVDR – IN-VITRO DIAGNOSTIC REGULATION)

In vitro diagnostic medical devices are also medical devices. They are still regulated in their entirety by the Medical Devices Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 98/09), while the European regulation for this area, i.e. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, will become applicable on 26 May 2022.

LEGAL BASIS:

Publication of the IVDR in the Official Journal of the European Union: 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 [ENG]

Corrigenda and an amendment of the regulation were adopted and published:
  • the first corrigendum was adopted on 13 March 2019 and published on 3 May 2019: link to the first corrigendum [ENG]
  • the second corrigendum was adopted on 3 December 2019 and published on 27 December 2019: link to the second corrigendum [ENG]
  • Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
TIMEFRAME FOR THE TRANSITION FROM THE DIRECTIVES TO THE REGULATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

Both regulations are binding in their entirety and directly applicable in all EEA member countries.

The regulations establish a more modern and solid regulatory framework, providing better public health, patient and user safety. New and improved rules bring about, among other things, also implant cards and information for patients with implanted devices, Unique Device Identifier (UDI), which allows clear identification of each device in the European Database on Medical Devices (EUDAMED), more emphasis on monitoring the device throughout its life span, and control after putting the device on the market.

A working group, including experts from the JAZMP, has been established at the Ministry of Health. They are drafting the Medical Devices Act to regulate certain areas at the national level the Republic of Slovenia, such as registration of distributors, fees for the activities of the competent authority, language requirements, etc., which is permitted by the MDR.

Additional information on the new 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 guidelines adopted by the Medical Device Coordination Group (MDCG) that helps stakeholders in implementing the regulations’ provisions can be accessed.

To view the factsheets with all the changes brought about by the MDR for economic operators and other stakeholders, click here.

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