Guidance and regulations
Published:
Changes
The Norwegian Medical Products Agency is the competent authority for medical devices in Norway. The Agency has administrative and advisory responsibilities related to legislation and supervisory authority over economic operators and notified bodies.
NOMA's role and competence
NOMA is the competent authority for medical devices in Norway, cf. the Act of May 7 2020 No. 37 on medical devices and the Regulation of May 9 2021 no. 1476 on medical devices.
As administrative, advisory and supervisory authority, NOMA can provide general guidance on the regulations, but it is beyond our role to give specific advice on how the requirements of the regulations should be met.
The Regulations
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).
EU regulations on medical devices
Supervision
NOMA is a supervisory authority and does not have an approval role for medical devices. This means, among other things, that we cannot approve documentation regarding the import or marketing of medical devices.
It is the responsibility of the manufacturer to ensure that the device is compliant. Medical devices that meet the requirements of the regulations must bear the CE mark and can then be freely traded in the EU/EEA area. Devices sold in Norway must have Norwegian labeling and instructions for use, cf. the regulation on medical device § 6