Standards and Common Specifications for Medical Devices in Norway

1. Legal Basis and Purpose

The regulations for medical devices set essential requirements for properties of devices placed on the market in Europe. Technical details and solutions supporting these requirements are described in European harmonised standards prepared by CEN and CENELEC and in monographs of the European Pharmacopoeia. Norway implements the MDR and IVDR directly through the EEA Agreement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

2. Harmonised Standards

Devices designed and manufactured in accordance with relevant harmonised standards and monographs published in the Official Journal of the European Union are considered to be in conformity with the requirements covered by the standard. Harmonised standards cover requirements for systems or processes such as quality management systems, risk management, post-market surveillance systems, clinical trials, and clinical evaluation or follow-up after market placement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

3. Presumption of Conformity

The use of harmonised standards is voluntary. However, only devices that conform to the relevant harmonised standards shall be presumed to be in conformity with the requirements covered by the standard. When using other standards or solutions, the manufacturer must document that the solution fully meets the requirements. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

4. Annex Z in Standards

The relationship between the requirements of a harmonised European standard and the medical device regulation is described in the foreword of the individual standard and in particular in Annex Z. Annex Z contains tables showing the correspondence between the standard and the medical device regulation and comments necessary for the correct use of the standard, such as if some legal requirements are not covered or only partially covered by the standard. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

5. Common Specifications

The page does not detail specific common specifications beyond the general reference to harmonised standards and monographs. Common specifications (when published by the European Commission) provide additional technical solutions for compliance with essential requirements in cases where harmonised standards are insufficient or absent. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

6. NoMA Role and Guidance

NoMA refers to MDR Article 8 and MDCG 2021-5 Guidance on standardisation for medical devices. Manufacturers should consult the European Commission’s website for the list of harmonised standards under «Healthcare engineering». NoMA’s medical device unit can be contacted for further advice. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications

7. Practical Considerations

Manufacturers must maintain documentation of compliance with standards or alternative solutions in the technical file. The application of standards supports the essential requirements of the MDR and IVDR. Incorrect or incomplete documentation of conformity may lead to enforcement actions by NoMA. https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/standards-and-common-specifications