Norwegian laws and Regulations on medical devices
Act of 7 May 2020 no. 37 on medical devices
The Act of 7 May 2020 no. 37 on medical devices applies to economic operators, and manufacturing, placing on the market and putting into service of medical devices.
The Act implements Regulation (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The Act will apply for MDR from 26 of May 2021 and for IVDR from 26 of May 2022.
It is also legal basis for national provisions, and for implementing acts from the EU-Commission.
Regulation 9 of May 2021 no 1476 on medical devices
The Regulation specifies the national provisions on competent authority, language requirements, clinical trials, cf. MDR Article 82 and clarification of the transitional provisions.
The regulations on IVD until IVDR applies from 26 of May 2022
Law of 12 January 1995 no. 6 on medical devices
The current law of 12 January 1995 no. 6 on medical devices applies as a legal basis for the Norwegian IVD-rules (directive 98/79/EC) until 26 May 2022.
Temporary Regulation on medical devices
Regulation 15 December 2005 no. 1690 on medical devices will, in a transitional phase, only apply for IVD until 26 May 2022. This is due to different enter into force for MDR (26 of May 2021) and IVDR (26 of May 2022)
Regulation of 29 November 2013 no. 1373 on use of medical devices
The regulation applies to the health care services use of medical devices, and any use of electromedical device by public and private business. The aim of the regulation is to ensure that medical devices are safe, are correctly maintained, and used correctly in accordance with its intended purpose.
The IN-house exemption for IVD-devices (IVD manufactured and used only within health institutions), will continue to apply in this Regulation until replaced by IVDR art 5 point 5 on 26 of May 2022.
Reprocessing of single-use devices will be permitted as a transitional arrangement in Norway until 1 January 2022. Entities which reprocesses single-use devices will be considered a manufacturer in accordance with MDR article 17 (2), cf. Regulation of 29 November 2013 no. 1373 on use of medical devices § 5.
From 1 January 2022, reprocessing single-use devices will not be permitted.
MDR and IVDR have been incorporated into the EEA Agreement by decision of the EEA Joint Committee and transposed into Norwegian Law and Regulations. MDR and IVDR will be applicable in Norway from:
· 26 May 2021: Regulation (EU) 2017/745 on Medical Devices
· 26 May 2022: Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices
The EU has revised the legal framework of the current 3 directives to reflect progress over the last 20 years.
For more information: https://ec.europa.eu/health/md_sector/new_regulations_en