Conformity Assessment Involving Notified Bodies for Medical Devices in Norway

1. Definition and Role of Notified Bodies

A notified body is an independent third party designated by authorities to assess whether medical devices and IVD medical devices meet the requirements of the MDR and IVDR. The notified body evaluates the manufacturer's technical documentation, clinical evidence, and quality management system. If compliant, it issues a certificate enabling CE marking and market placement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

2. When Notified Body Involvement is Required

Notified body involvement is mandatory for:

• Medical devices in Class IIa, IIb, and III
• Certain Class I devices (sterile - Is, measuring - Im, reusable surgical instruments - Ir)
• Custom-made implantable devices in Class III
• IVD medical devices in Class B, C, and D
• Certain Class A IVDs placed on the market in sterile condition Class I (non-sterile, non-measuring) and Class A (non-sterile) devices are self-assessed by the manufacturer. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

3. Manufacturer Responsibilities

The manufacturer selects a notified body designated for the relevant device category (as per Regulation (EU) 2017/2185 codes). The manufacturer must submit an application for conformity assessment, providing full technical documentation and QMS details. Only one notified body may be used at a time for the same device. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

4. Assessment Process

The notified body conducts:

• Review of technical and clinical documentation
• Audits of the manufacturer's quality management system (announced and unannounced inspections)
• Issuance of a certificate if compliant The manufacturer is responsible for maintaining ongoing compliance, including post-market surveillance. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

5. NoMA's Role in Designation and Monitoring

The Norwegian Medicines Agency (NoMA) designates and monitors notified bodies in Norway through a joint European assessment procedure. Designated notified bodies are reassessed every five years. NoMA performs regular inspections. Manufacturers can find designated notified bodies in the European NANDO database. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

6. Transitional Arrangements

Notified bodies designated under the old directives (MDD, AIMDD, IVDD) must be redesignated under the new regulations. During transition, both old and new designations may apply. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body

7. Practical Advice for Manufacturers

Choose a notified body with appropriate scope. Prepare comprehensive documentation early. Contact NoMA for questions on designation or procedures. Non-compliance may prevent market placement. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/conformity-assessment-involving-notified-body