Danish Medicines Agency · Europe

Denmark 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 Danish Medicines Agency policy, guidance, safety, and compliance updates.

AI medical device classifier

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

Government registration fees

Review current Danish Medicines Agency application, review, and renewal fees.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Denmark 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 55 source-linked facts →

23 of 25 research dimensions currently covered · 34 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Role split for borderline product categories: DKMA's delineation guidance assigns borderline product categories to other authorities: medicines (incl. herbal and homeopathic products) to DKMA, food supplements to the Danish Veterinary…
Competent authority: The Danish Medicines Agency (Lægemiddelstyrelsen) is the competent authority for medical devices in Denmark, responsible for notified bodies ('bemyndigede organer') and for authorisation, m…

3 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National sanctions for violating MDR/IVDR and the device regulation: Violation of MDR/IVDR (and rules issued under them), or of the national device regulation's core duties, is punishable in Denmark: fine or imprisonment up to 1 year and 6 months for violati…
Official legal and guidance surface: authority: Danish Medicines Agency (Lægemiddelstyrelsen) · submissionSurface: EUDAMED plus Danish national registration for distributors and specialty retailers · verifiedHighlights: Nation…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition and national scope: Denmark applies the EU (MDR) definition of a medical device, including software; the delineation to medicines turns on the principal mode of action (devices act physically/mechanically, not…

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

National derogation from CE marking (MDR Art 59 / IVDR Art 54): The Danish Medicines Agency operates a national exemption scheme under MDR Article 59 / IVDR Article 54 allowing a specific device to be marketed/used in Denmark without conformity assessme…
National notification duty for class I / IVD manufacturers and system-pack producers: A manufacturer of class I devices or IVDs domiciled in Denmark (and a Danish authorised representative for a non EU/EEA manufacturer) must notify the Danish Medicines Agency of company name…

4 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:dnk · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

3 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

National registration duty for importers and distributors: Importers and distributors of devices or IVDs established in Denmark must notify the Danish Medicines Agency of name, address, CVR number, phone, e mail, role, and data identifying the devi…
Reprocessor of single-use devices assumes manufacturer obligations: Reprocessing and further use of single use devices may only take place in accordance with MDR Article 17(2); the reprocessor assumes the obligations of a manufacturer under the MDR and the…

3 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Pharmacy-only retail for HIV-detection IVDs: IVD devices intended for detection of HIV infection (HIV type 1 or 2) may only be sold to private persons at pharmacies, including pharmacy branches and pharmacy outlets.

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Clinical investigation dossier: language and routing: Until the EUDAMED clinical investigation portal is ready, sponsors apply directly to the authorities: the application (English language application form) with all documents is sent by e mai…
Notified-body designation applications must be in English: Documents submitted to the Danish Medicines Agency in applications for designation as a conformity assessment body (notified body) under MDR Articles 38 39 and IVDR Articles 34 35 must be d…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Clinical investigation application form and channel: Until EUDAMED is operational, the sponsor applies for a clinical investigation authorisation using the Danish application form 'Ansøgningsskema til ansøgning om tilladelse til klinisk afprø…
National distributor/specialty-retailer registration portal: Distributor and specialty retailer registration is done by logging in with MitID Erhverv and completing the registration form at portal.dkma.dk/mudregistrering ('Registreringsskema til medi…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Danish language requirement for label and IFU: Labelling and instructions for use (brugsanvisning) for devices and IVDs must be in Danish when the device is made available to the final user or patient in Denmark. DKMA may exceptionally…
DKMA may order EU declaration of conformity translated into Danish: The Danish Medicines Agency may in individual cases order a manufacturer to translate an EU declaration of conformity into Danish when necessary for DKMA's market surveillance; non complian…

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Danish notified bodies must report certificate decisions to DKMA: Notified bodies ('bemyndigede organer') in Denmark must notify the Danish Medicines Agency of all issued, changed, extended, suspended or withdrawn certificates and of refusals of certifica…

1 source-linked fact

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
Radioudstyrsloven market access: Wireless / radio

7 maintained overlays · 1 related fact

Checked 2026-08-25

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D14

Fees

Verified

Distributor/importer registration: DKK 1,238
Manufacturer/authorised-representative registration: DKK 1,234

16 maintained fee lines · 5 related facts

Checked 2026-08-25

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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

Clinical investigation documentation retention 10/15 years: The sponsor must keep the MDR Annex XV documentation (Annex XIV for IVD performance studies) available for the Danish Medicines Agency for at least 10 years after the clinical investigation…
National registration has no expiry; annual fee runs until cessation: The Danish national distributor/specialty retailer registration does not expire, but the annual supervision fee must be paid through and including the calendar year in which the company cea…

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Substantial modifications of clinical investigations need prior DKMA approval: Changes to an authorised clinical investigation that may materially affect the safety, health or rights of trial subjects, or the robustness or reliability of the clinical data, require pri…
Changes and cessation of national registration must be notified: Manufacturers, authorised representatives, importers, distributors and specialty retailer owners that have notified/registered with the Danish Medicines Agency must notify any change to the…

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Health institutions must hand over implant cards: Danish health institutions must hand over the implant card and make the MDR Article 18(1) information available to patients who have received an implant.
Official UDI or listing surface: submissionSurface: EUDAMED for manufacturers, importers and authorised representatives; Danish national electronic register for distributors and specialty retailers; DKMA publishes bruttoli…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical investigation authorisation route via DKMA: Clinical investigations under MDR Article 62(1) may only start after authorisation from the Danish Medicines Agency; the application under MDR Article 70 is submitted by the sponsor or the…
IVD performance study route via DKMA: Applications for performance studies within IVDR Article 66(1) are submitted by the sponsor or the sponsor's representative to the Danish Medicines Agency; DKMA cannot authorise if there is…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

National CE-marking derogation for specific devices (MDR Art 59 / IVDR Art 54): Denmark operates the MDR Article 59 / IVDR Article 54 derogation: DKMA may authorise, for a limited period, the making available of a specific device on the Danish market without conformity…

1 source-linked fact

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Trend reporting and periodic reporting agreements per DKMA guidance: DKMA guidance for manufacturers requires trend reporting when the frequency of events increases relative to the accepted frequency in the risk analysis (trend reports go to the authority in…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

DKMA may impose extended incident-reporting duty for specific devices: The Danish Medicines Agency may in special cases decide that the incident reporting duty extends to any incident with a specific type of device or IVD that could cause or could have caused…
Hospitals and professional users must report incidents immediately: Operators of public and private hospitals must immediately ('straks') report to the Danish Medicines Agency any incident with a device or IVD that could cause or could have caused death of…

5 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

DKMA may order recalls, buy-backs and remedial action: As part of its control, the Danish Medicines Agency can issue injunctions and prohibitions against actors it supervises (manufacturers/authorised representatives, distributors, importers, n…
FSCA notices to DKMA; NCAR within 14 days: Field safety corrective action notices (MDR Art 87(1)(b)) must be sent to the Danish Medicines Agency for devices on the Danish market; per DKMA guidance, an FSCA must always be reported to…

3 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

National content rules for device advertising: Advertising for medical devices must be adequate and factual and must not be liable to endanger the safety or health of patients, users or third parties; information must be consistent with…
Economic benefits to health professionals restricted; annual transparency disclosure: Economic benefits to health professionals to promote device sales are prohibited, subject to narrow allowances (discounts, insignificant work related gifts, device loans up to 2 months for…

3 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Administrative appeal of DKMA device decisions: The minister may set rules on appeal of notified body decisions and of DKMA decisions under the device act and under the EU device regulations, including rules that named DKMA decisions can…
Forvaltningsloven hearing and comment before a DKMA decision: Before DKMA decides a device matter on facts or external expert assessments that are unfavourable to the party and of material importance, and that the party cannot be assumed to know the a…

2 source-linked facts

Checked 2026-08-30

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Government fees

Full fee schedule (16 lines) →

Danish Medicines Agency registration fees in DKK · reviewed 2026-08-25

Fee line	Amount	Provenance
Distributor/importer registration	DKK 1,238	Verified
Manufacturer/authorised-representative registration	DKK 1,234	Verified
Annual supervision fee - manufacturers/AR of low-risk products	DKK 6,298–56,682	Verified
Annual supervision fee - manufacturers/AR of medium/high-risk products	DKK 32,403–291,639	Verified