Norwegian laws and regulations on medical devices
Act 7 May 2020 no. 37 on medical devices
Act 7 May 2020 no. 37 on medical devices implements Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The Act on Medical Devices is legal basis for national provisions, and for implementing acts from the European Commission.
Regulation 9 May 2021 no. 1476 on Medical Devices
The Regulation on medical devices specifies the national provisions on competent authority, language requirements, clinical trials, cf. MDR Article 82 and clarification of the transitional provisions.The Regulation on medical devices also contains provisions on administrative sanctions and penalties.
Regulation 29 November 2013 no. 1373 on the use of medical devices
The Regulation on the use of medical devices applies to the use of medical devices, and any use of electromedical device by public and private businesses. The aim of the regulation is to ensure that medical devices are safe, correctly maintained and used correctly in accordance with its intended purpose.
Reprocessing of single-use medical devices
Reprocessing of single-use devices is not permitted in Norway.
EU Regulations MDR and IVDR
MDR and IVDR have been incorporated into the EEA Agreement by decision of the EEA Joint Committee and transposed into Norwegian law and regulations.
The EU has revised the legal framework of the former three directives to reflect progress over the last 20 years.
More information can be found on the European Commission's web page.
MDCG Guidance Documents
Guidance documents to MDR and IVDR are available on the European Commission's web page. Most of the guidance documents are endorced by the Medical Device Coordination Group (MDCG). The guidance documents are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.