Regulation in the field of medical devices
- Regulation (EU) 2017/745 on medical devices (MDR– Medical Device Regulation)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR– In-Vitro Diagnostic Regulation)
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]
- 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]
- the regulation amending the dates of application of the MDR was adopted on 23 April 2020 and published on 24 April 2020 – Regulation (EU) 2020/561: link to the regulation amending the MDR [ENG]
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.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices, became 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]
- 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
- Consolidated text of Regulation (EU) 2017/746. Current consolidated version: 28/01/2022.
TIMEFRAME FOR THE TRANSITION FROM THE DIRECTIVES TO THE REGULATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
On 25 January 2022, REGULATION (EU) 2022/112 was adopted at EU level regarding transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.
From 26 May 2022, the following in vitro diagnostic medical devices may be placed on the European Union market or put into service, subject to the amendment of Regulation 2017/746/EU:
- IVDR compliant Class A, B, C and D in vitro diagnostic medical devices.
- in vitro diagnostic medical devices of classes B, C and D that meet the conditions set out in the transitional provisions of Article 110 IVDR, amended by Regulation 2022/112/EU:
A/ with certificates issued according to the Directive 98/79/EC before 25 May 2017 until the certificate expires:
- certificates remain valid until the date on the certificate;
- certificates issued in accordance with Annex VI to Directive 98/79/EC are valid until 27 May 2025 at the latest.
B/ with certificates issued according to Directive 98/79/EC after 25 May 2017 until the certificate expires:
- certificates become invalid no later than 27.5.2025.
C/ if after 26.05.2022 they comply with Directive 98/79/EC and the design and intended purpose have not changed significantly, they may be placed on the market or put into service:
- if they have a valid certificate issued in accordance with Directive 98/79/EC until 26 May 2025.
D/ If they comply with Directive 98/79/EC after 26/05/2022, if the design and intended purpose have not changed significantly, and for specific in vitro diagnostic medical devices according to Directive 98/79/EC:
- it was not necessary to include a notified body when determining compliance (devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body);
- the declaration of conformity was drawn up prior to 26 May 2022 and
- for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body (in accordance with the IVDR, they are classified in class B, C, D or A-sterile IVD MP), may be placed on the market or put into service until the following dates:
- 26 May 2025, for class D devices (available on the market or put into service until: 26.5.2026)
- 26 May 2026, for class C devices (available on the market or put into service until: 26.5.2027)
- 26 May 2027, for class B devices (available on the market or put into service until: 26.5.2028)
- 26 May 2027, for class A devices placed on the market in sterile condition (available on the market or put into service until: 26.5.2028).
The requirements of the IVDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to all in vitro diagnostic medical devices on the market, both for those compliant with the provisions of the IVDR and those compliant with Directive 98/79/EC, which are on the market in accordance with the transitional provisions of the IVDR and Regulation 2022/112/EU. 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 and IVDR.
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.