The legislation for medical devices
Common European legislation through the EEA Agreement
Through the EEA Agreement, Norway has the same regulations as EU countries regarding the requirements for marketing and distributing medical devices. The regulations for medical devices primarily consist of two regulations: Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The main principle of the medical device regulations is that the manufacturer is legally responsible for ensuring the safety and efficacy of medical devices. Devices that meet safety requirements are labeled with the CE mark and can be freely circulated within the EEA area. Medical devices do not require approval from national authorities before they can be marketed. For certain risk classes of medical devices, a notified body must conduct a conformity assessment before the devices can be freely marketed. This involves the notified body evaluating whether the product complies with the safety requirements in the regulations.
National Requirements for medical devices in Norway
MDR and IVDR allows for national authorities to introduce national provisions. This means that national authorities can establish national requirements and adapt the regulations to national conditions. The national provitions in Norway may be found in the regulation on medical devices section 6-16. Here is a list of requirements that specifically apply to medical devices in Norway:
Information on the label and in the user manual of the device must be provided in Norwegian.
Documentation used in conformity assessment procedures, including technical documentation, as well as audit, assessment, and inspection reports, must be provided in English.
Information in the Declaration of Conformity must be in English or Norwegian.
Certificates issued by notified bodies established in Norway must be in English or a language accepted by the notified body.
Upon request from the Norwegian Medicines Agency, the manufacturer and authorized representative must provide all necessary information and documentation to demonstrate compliance with the requirements in Norwegian or English.
Information in the application for designation of a notified body and the documents assessed during inspections must be in English.
Safety notifications from manufacturers to users of devices must be in Norwegian.
Information provided to patients with implantable devices and intended to be accompanied by an implant card must be in Norwegian.
The general summary of clinical trials must be in Norwegian and English.
Clinical trials must meet the requirements of Regulation (EU) 2017/745 (MDR) Article 62. This also applies to clinical trials not conducted for the purposes specified in Article 62(1) of the regulation.
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.
EU regulations on medical devices
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.