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Norwegian Medical Products Agency · Europe

Norway medical device regulatory resources

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5 free resources23/25 topics with recordsAug 2026 fees reviewed
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Medical device regulation news

Follow recent Norwegian Medical Products Agency (DMP/NOMA) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary DMP risk class with official rule references.

Government registration fees

Check the current Norwegian Medical Products Agency position on device and IVD fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Norway requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 43 source-linked facts →

23 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
Direktoratet for medisinske produkter (English: Norwegian Medical Products Agency, NoMA/DMP; website dmp.no; formerly Statens legemiddelverk) is the competent authority for medical devices…
National handling regulation for the health service
A separate national regulation on handling of medical devices (Forskrift om håndtering av medisinsk utstyr, FOR 2013 11 29 1373) binds the health and care service (and other entities handli…
4 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
National legal basis
nationalImplementingAct: Lov om medisinsk utstyr (Act of 7 May 2020 No. 37) · nationalSupplementingRegulation: Forskrift om medisinsk utstyr (FOR 2021 05 09 1476), in force 26 May 2021 · ee…
1 source-linked fact
Checked 2026-08-25
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D03

Device definition & scope

Verified
Borderline qualification decision
In cases of doubt, Direktoratet for medisinske produkter decides whether a product is to be regarded as a medical device (national rule; device definition itself follows MDR/IVDR Article 2…
1 source-linked fact
Checked 2026-08-25
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D04

Classification rules

Verified
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III
1 maintained scheme
Checked 2026-08-26
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D05

Registration pathways

Verified
Market-access registration route
submissionSurface: EUDAMED · obligation: Manufacturers must register their devices in EUDAMED prior to placing the devices on the market in Norway/EU EEA. · transitionDeadline: Devices plac…
Public device register duty
Anyone with a business address in Norway who produces and markets medical devices in their own name (including as systems or procedure packs) must enter company name, organisation number, b…
2 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity
target: geo:nor · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Authorised representative for non-EEA manufacturers
A manufacturer without a business address in the EEA that markets devices in its own name in the EEA must, before marketing, appoint an authorised representative established in the EEA; an…
EUDAMED actor registration and SRN
Manufacturers, authorised representatives, importers and system/procedure pack assemblers must register in the EUDAMED actor registration module and receive a Single Registration Number (SR…
2 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Economic operator registration (EUDAMED)
Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, o…
1 source-linked fact
Checked 2026-08-29
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D09

Dossier requirements

Verified
Documentation language on authority request
On request from Direktoratet for medisinske produkter, the manufacturer and the authorised representative must present all information and documentation necessary to demonstrate the device'…
1 source-linked fact
Checked 2026-08-25
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D10

Official forms & portals

Verified
Clinical investigation submission channel and forms
Until EUDAMED is available, clinical investigation applications are submitted by email to kki@dmp.no with the subject 'Søknad om klinisk utprøving av medisinsk utstyr' plus sponsor and devi…
Official form or portal surface
submissionSurface: EUDAMED · details: Actor and device registration in Norway takes place in EUDAMED; the CA (dmp.no) publishes the registration pages. Clinical investigation submissions us…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Implant card information in Norwegian
Information given to patients with implantable devices that is to accompany an implant card must be provided in Norwegian.
Exemption from Norwegian language requirement
Direktoratet for medisinske produkter may exempt a device from the Norwegian language requirement for labels/IFU where safe and correct use is ensured; exemptions are not granted on a gener…
3 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
Norwegian notified body
DNV Product Assurance AS has been designated by the Norwegian Medical Products Agency as a notified body under the MDR and, as the first Norwegian notified body for IVDs, under the IVDR.
Notified-body designation and oversight authority
Direktoratet for medisinske produkter designates and supervises notified bodies in Norway (per MDR Article 35 and IVDR Article 31, read with the Act on technical control bodies).
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
MDR electrical safety in place of the Low Voltage Directive
Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive
EMC
EEA radio equipment forskrift market access
Wireless / radio
8 maintained overlays
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D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
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D16

Approval validity & renewal

Verified
Certificate validity and renewal (Art. 56(2))
EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…
1 source-linked fact
Checked 2026-08-29
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Lifecycle & post-market

D17

Change control

Verified
Notified-body certificate reporting to CA
Notified bodies must inform Direktoratet for medisinske produkter about all certificates issued, amended, extended, suspended, withdrawn or refused (and inform other notified bodies about s…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Official UDI/listing surface
submissionSurface: EUDAMED · details: Device registration (with UDI data) takes place in EUDAMED; devices placed on the market before 28 May 2026 must be registered by 28 November 2026.
1 source-linked fact
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigations requiring application to DMP
An application to DMP is required for clinical investigations of devices that are not CE marked, or CE marked devices investigated outside the manufacturer's stated intended purpose; this c…
MDR Article 62 requirements extended to all investigations
National special requirement: clinical investigations conducted for purposes other than future conformity assessment and CE marking (MDR Article 82) must fulfil all requirements of MDR Arti…
5 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
National exemption (dispensation) power
Direktoratet for medisinske produkter may, in special cases, grant exemptions from provisions laid down in or under the Medical Devices Act, provided this does not conflict with Norway's in…
1 source-linked fact
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance reporting (Arts. 83-86)
Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…
1 source-linked fact
Checked 2026-08-29
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D22

Vigilance & incident reporting

Verified
Serious incident reporting deadlines
seriousPublicHealthThreat: 2 days · death: 10 days · unexpectedSeriousDeterioration: 10 days · otherSeriousIncidents: 15 days · clock: From the date the manufacturer became aware of the inc…
Healthcare facility reporting duty
Healthcare facilities in Norway have a national obligation to report serious incidents that have or may have a connection with the use of a medical device; they report via the national repo…
4 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA reporting channel
Reports on field safety corrective actions and the field safety notice for devices on the Norwegian market or from Norwegian manufacturers shall be sent to the Norwegian Medical Products Ag…
Field safety notice language
Safety communications from manufacturers to users of devices must be given in Norwegian; in special cases they may be given in English until a Norwegian translation is available, and the No…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Misleading claims prohibition (Art. 7)
In the labelling, instructions for use, making available, putting into service and advertising of devices it is prohibited to use text, names, trade marks, pictures and figurative or other…
1 source-linked fact
Checked 2026-08-29
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D25

Submission communications & appeal

Verified
Appeal against authority decisions
Individual decisions (enkeltvedtak) of Direktoratet for medisinske produkter may be appealed under the Public Administration Act § 28 to the immediately superior administrative organ (for a…
1 source-linked fact
Checked 2026-08-25
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Government fees

Full fee schedule (1 lines) →

Norwegian Medical Products Agency registration fees in NOK · reviewed 2026-08-25

Fee lineAmountProvenance
Processing of clinical-investigation applications and notificationsNOK 0Verified

Registration timeline

Full registration timeline →

Norwegian Medical Products Agency (Norwegian Medical Products Agency) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
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Norway market-launch workpaper

Connect the Norwegian Medical Products Agency route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Norway dossier reuse and delta

Compare an existing authorization and evidence set against Norwegian Medical Products Agency administrative, testing, labeling, and dossier needs.

Norway change notification workpaper

Map a product or manufacturing change to Norwegian Medical Products Agency evidence, notification, timing, and implementation questions.

Norway regulatory change impact

Assess a current Norwegian Medical Products Agency update against one product and turn it into an owner-ready action workpaper.

Norway cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Norway (Norwegian Medical Products Agency).

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