Norway Medical Device Registration

Understanding Medical Device Registration and Vigilant System in Norway

Regulatory Authority

Norwegian Medicines Agency

The Norwegian Medicines Agency (NOMA) is a government agency under the Ministry of Health and Care Services, tasked with ensuring public and animal health by ensuring the safety, quality, and efficacy of medicines and enforcing medical device regulations.

Their tasks include assessing medicines, administering the pharmaceutical distribution chain, determining prescription medicine prices, and evaluating cost effectiveness. They also supervise clinical trials, marketing, and safety deficiencies. NOMA also provides medical information, regulations, and advice to doctors and the general public.

They also manage medical devices legislation, monitor the market, and participate in international cooperation.

NOMA also represents Norway in EU scientific committees and working parties, participates in European co-operation, and makes assessments of medicines on behalf of the European Medicines Agency.

Link for Regulatory Authority

https://legemiddelverket.no/english

Local Regulation

EU MDR 2017/745

Classification of Medical Device

Class I, IIa, IIb and III

Listing or Registration Requirements

• Have systems for risk management and quality management (QMS).
• Compile technical documentation.
• Have an Authorised Representative.
• Apply a conformity assessment procedure.
• Have a named person responsible for regulatory compliance
• For some implantable devices; provide an implant card for the patient
• Draw up a declaration of conformity and apply CE marking to their devices (when the obligations mentioned above are fulfilled)

Documents Required

• Background for the application
• Name of the device and a description of usage
• EC-certificate of the device (where appropriate) and the Declaration of Conformity
• Name of the user of the device, e.g., health institution, hospital, etc.
• Statement from the user on safe and proper use without Norwegian label and instructions for use
• A copy of the label/instructions for use

Registration Timeline

The registration process takes approximately the same time as in the EU

License Validity

5 years

Special Labelling Requirements

Norwegian labeling and IFU

Serious Incidents and Field Safety Corrective Actions

Incidents with medical devices on the market related to accidents and failures defined as serious incidents must to be reported to the Norwegian Medical Products Agency.

Incidents

Incidents involving medical devices refer to any malfunction or deterioration in the properties or performance of the device.

This also includes:

• Use errors due to ergonomic features
• Inaccuracies in information provided by the manufacturer
• Undesirable side effects (MDR – Medical Device Regulation)
• Harm resulting from a medical decision and actions taken or not taken based on the information or results provided by the device (IVDR – In Vitro Diagnostic Regulation)

Serious Incidents

A serious incident is defined as any event that has directly or indirectly led to, could have led to, or may lead to any of the following:

• Death of a patient, user, or another person
• Temporary or permanent severe deterioration in a patient’s, user’s, or another person’s health condition
• Serious public health threat

Serious incidents involving medical devices in the Norwegian market must be reported to the Norwegian Medical Products Agency (NoMA)

Healthcare facilities are obligated to report serious incidents that are or may be related to the use of a medical device.

Reporting Deadlines

The manufacturer can submit a combined preliminary and final report if they have all the necessary information to complete within deadlines. If an incident cannot be determined, it should be reported within the deadline. The manufacturer can submit an incomplete preliminary report and then a complete report after obtaining all necessary information and completing the investigation.

Field Safety Corrective Action

A field safety corrective action is an action that manufacturers can implement based on technical or medical reasons to prevent or reduce the risk of serious incidents when using a medical device that has been placed on the market.

The Norwegian Medical Products Agency is responsible for ensuring that manufacturers implement field safety corrective actions as planned. The agency assesses received reports and monitors their implementation, evaluating the sufficiency of the manufacturer’s measures and determining if additional corrective measures are needed. The agency collaborates with other EU authorities to monitor these actions. When a Norwegian manufacturer reports a safety corrective action, the information is shared with the European network, ensuring other authorities in the countries where the medical device is on the market are informed, in addition to the manufacturer’s own notification.

Additional Comments

• Audits: An ISO 13485 audit, based on the CE requirements, is required.
• Technical Local Tests: No local testing is required.
• Clinical Evaluation/studies: No clinical evaluation studies are required.

Who should make this communication?

• Manufacturer
• Authorized Representative

When to make this communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk