Medical Device Regulations and Registration Process in Denmark

Denmark has no separate national approval system for medical devices. If a device carries valid CE marking under EU MDR or EU IVDR, it can be sold in Denmark without any extra government approval. The Danish Medicines Agency confirms this directly, stating that devices are “not subject to pre-market authorisation.” On top of CE marking, Denmark requires correct classification, Danish-language labelling, an EU Authorised Representative for non-EU manufacturers, national registration for any operator established in Denmark, and ongoing vigilance reporting once the device is on the market.

This article works through the Denmark Medical Device Registration Process step by step and covers Denmark MDR Compliance in practical terms.

Regulatory Authorities for Medical Devices in Denmark

Four bodies matter here and knowing which one does what saves a lot of confusion later.

General import and customs matters at the Danish border fall to Danish customs authorities, not the Danish Medicines Agency.

Denmark Medical Device Classification

Denmark follows the EU classification system under the applicable EU medical device legislation. For MDR-regulated medical devices, it does not maintain a separate Danish classification system.

The device must be classified according to the applicable rules specified in Annex VIII of Regulation (EU) 2017/745. For in vitro diagnostic devices, the applicable rules are specified in Annex VIII of Regulation (EU) 2017/746.

Classification decides almost everything downstream. Class I devices can generally rely on manufacturer self-declaration, while Class IIa, IIb and III devices need a Notified Body to review technical documentation and higher classes carry heavier clinical evidence and post-market obligations.

Authorized Representative (EC REP) Requirements in Denmark

A manufacturer based outside the EU cannot place a device on the Danish market, or any EU market, without first appointing one.

Under MDR Article 11, the Authorised Representative acts as the manufacturer’s legal contact point inside the EU. Its responsibilities typically include keeping the Declaration of Conformity and technical documentation available for inspection, cooperating with competent authorities such as the Danish Medicines Agency and supporting incident and field safety corrective action reporting.

The relationship between the manufacturer and Authorised Representative must be formalised through a written mandate. The Authorised Representative’s name and address also need to appear on the device label.

Article 13 covers the general obligations of importers, while Article 15 addresses the Person Responsible for Regulatory Compliance, a related but separate role.

On the Danish side, incident reporting rules give the Authorised Representative an active role: Authorised Representatives must immediately report suspected serious incidents to the manufacturer and have the possibility to report suspected serious incidents directly to the Danish Medicines Agency.

Separately, where the Authorised Representative is itself established in Denmark, it also falls under the Danish national registration requirement described in the next section, in addition to its EU-level obligations.

Medical Device Regulations and Guidelines in Denmark

Manufacturers should build their compliance approach on a defined stack of sources, in this order of priority:

• Regulation (EU) 2017/745 and Regulation (EU) 2017/746, the core EU legislation
• MDCG guidance documents, published by the European Commission’s medical devices sector
• The Danish Act on Medical Devices, Denmark’s primary national legislation in this area
• Danish executive orders, including rules on labelling, language, national registration and advertising, published on retsinformation.dk
• Danish Medicines Agency guidance, including its published guidance for new manufacturers, distributors and labelling requirements

Denmark operates inside the EU medical device regulatory system and its national legislation exists to implement and supplement the MDR and IVDR. Where Danish executive orders add something specific, such as the Danish-language labelling rule or the national economic operator registration duty, that addition is clearly Danish in origin. Everything else, including classification and technical documentation content, comes directly from EU law.

Medical Device Registration Process in Denmark

CE marking and Danish national registration are not the same regulatory action and they do not happen at the same stage of the process or serve the same purpose. CE marking is the EU-wide conformity signal that allows a device to be placed on any EU market, including Denmark’s. Danish registration is a separate, national duty that applies to the economic operator itself and only where that operator is established in Denmark.

Step 1: Determine the device classification. Work through MDR Annex VIII (or IVDR Annex VIII for IVDs) before anything else, since classification decides every step that follows.

Step 2: Confirm the product actually qualifies as a medical device. Borderline products and combination products deserve a documented intended-purpose assessment before technical work begins.

Step 3: Complete the appropriate conformity assessment. For Class I devices, self-declaration is usually available. For Class IIa, IIb and III devices, a Notified Body assessment is required under MDR Annexes IX, X or XI, depending on the route chosen.

Step 4: Prepare technical documentation. Content requirements falls under MDR Annex II and Annex III, covering device description, design information, risk management and performance data.

Step 5: Complete clinical evaluation. MDR Article 61 and Annex XIV set out what a Clinical Evaluation Report needs to demonstrate, scaled to the device’s risk class and novelty.

Step 6: Establish the Quality Management System. MDR Article 10 requires a QMS proportionate to the device’s risk, and ISO 13485 is the standard most manufacturers use to meet it.

Step 7: Appoint an EU Authorised Representative. Required for manufacturers with no legal presence inside the EU.

Step 8: Register with the Danish Medicines Agency, if established in Denmark. Manufacturers, Authorised Representatives, importers, distributors and specialty stores established in Denmark must register their company and product categories with the Danish Medicines Agency, separately from EUDAMED. This is a company registration, not a device approval; the device itself is never submitted for Danish pre-market review.

Registration runs through an online form using MitID Erhverv, recording company name, address, CVR number, actor role, and product categories. It’s tied to the CVR number, so any change in company details needs an updated form. It applies only to operators actually established in Denmark. A foreign manufacturer shipping in through a Denmark-based importer should confirm which party in the chain owes this duty.

Step 9: Meet Danish labelling and language requirements.

Step 10: Place the device on the Danish market. At this stage, manufacturer, importer, and distributor obligations under MDR Articles 13 and 14 all become active.

Step 11: Maintain post-market surveillance and vigilance. This is not a one-time step; it runs for as long as the device stays on the market.

Documentation Requirements for Medical Devices in Denmark

Depending on the device and the manufacturer’s situation, the following documents typically come into play:

• EU Declaration of Conformity, confirming MDR or IVDR compliance
• Technical Documentation under MDR Annex II, along with Annex III post-market surveillance documentation where applicable
• Clinical Evaluation Report, demonstrating safety and clinical performance
• QMS documentation, reviewed during Notified Body audits for Class IIa and above
• Notified Body certificate, for devices that required Notified Body involvement
• Authorised Representative mandate, the written agreement between the manufacturer and its EC REP
• UDI record, registered in EUDAMED and retained by the manufacturer
• Danish national registration form, for manufacturers, Authorised Representatives, importers, distributors or specialty stores established in Denmark
• Danish-language labelling and instructions for use, applied to the device and packaging
• PMS and vigilance documentation, including incident reports where a reportable event occurs

Of everything on this list, the Danish national registration form is the one document actively and routinely submitted to the Danish Medicines Agency. Everything else stays with the manufacturer or Authorised Representative and is produced only if requested during market surveillance or a Notified Body audit.

QMS Requirements for Medical Devices in Denmark

Denmark follows the EU MDR requirements for manufacturer Quality Management Systems rather than operating a separate Danish QMS system for MDR-regulated medical devices. MDR Article 10 requires manufacturers to establish, document and maintain a QMS proportionate to the risk class and type of device. ISO 13485 is the internationally recognised standard most manufacturers use to satisfy this requirement. It covers design controls, supplier management, production controls, complaint handling, corrective and preventive action, and post-market surveillance.

ISO 13485 certification is not automatically a general legal requirement written into the MDR text for every single device class. But in practice, Notified Body involvement for Class IIa and above makes a certified QMS close to unavoidable, while even self-declaring Class I manufacturers need a functioning QMS to meet Article 10 obligations.

Medical Device Labelling Requirements in Denmark

General MDR content requirements for labelling and IFUs are set out in Annex I, Section 23 of the MDR (and the equivalent IVDR section), covering device identification, manufacturer and Authorised Representative details, UDI, warnings, and CE marking placement. On top of that, Denmark’s own language rule works as follows:

Registration Timelines for Medical Devices in Denmark

There is no single official Denmark Medical Device Registration Timeline published by the Danish Medicines Agency for device market entry, because there is no standard pre-market device approval step for the Agency to time. The Danish national registration duty covered in Step 8 (for manufacturers, Authorised Representatives, importers, distributors, and specialty stores established in Denmark) is an administrative company registration, not a reviewed application with a stated processing period.

What does affect a manufacturer’s overall market-entry timeline includes:

• Notified Body assessment duration, which varies heavily by device class and Notified Body workload
• Technical documentation and clinical evaluation readiness
• QMS certification status
• Completeness of the Danish national registration information, where applicable
• EUDAMED registration
• Danish-language labelling and translation lead time

Medical Device Registration Costs in Denmark

Danish medical device fees are governed by two executive orders. One covers manufacturers and Authorised Representatives, while Executive Order No.1733 of 8 December 2025 covers importers and distributors. Fees are adjusted every 1 January, so the Danish Medicines Agency’s current fee-rates page should be used for the applicable amounts.

A certificate of free sale costs DKK 1,362 per certificate in 2026. Beyond that there is no single flat registration fee. A registration fee applies only to manufacturers and Authorised Representatives of Class I devices, custom-made devices, IVDs, and system or procedure packs. Manufacturers and Authorised Representatives of Class IIa, IIb, and III devices are exempt.

Manufacturers, Authorised Representatives, importers, and distributors, except specialty stores, must also pay an annual supervision fee. The amount depends on the actor’s role, the device risk class and the number of employees at the registered company.

Clinical investigation authorisation under the MDR is also subject to fees. An application fee is applied (ranging from DKK 46,835 to DKK 62,947 depending on device class, or DKK 10,364 for a modification), plus an annual supervision fee of DKK 13,069 for the duration of the investigation, as set out on the Agency’s clinical investigations fee page.

Import Requirements for Medical Devices in Denmark

Denmark’s import requirements are split into two parts. The first is regulatory compliance. This means verified CE marking, correct classification, complete manufacturer and Authorised Representative details on the label, UDI compliance, Danish national registration if the importer or distributor is Denmark-based, and Danish-language labelling. Under MDR Article 13, importers must confirm the manufacturer and Authorised Representative have met their obligations before placing a device on the market. General customs procedures at the border fall under Danish customs authorities, not the Danish Medicines Agency.

The second part is incident reporting. Importers and distributors must immediately report suspected serious incidents to the manufacturer and Authorised Representative. Importers may also report directly to the Danish Medicines Agency.

PMS Requirements in Denmark

Post-Market Surveillance (PMS) is an ongoing manufacturer obligation under the EU MDR and it continues well after CE marking and Danish market entry. Manufacturers must run a surveillance system that receives and processes safety and performance information after marketing, identifies malfunctions and deficiencies, and reports serious incidents and field safety corrective actions to the authorities, making product changes where risks are identified.

On reporting specifically, manufacturers must report serious incidents to the Danish Medicines Agency within the applicable MDR deadlines set out in Articles 87 through 92. Healthcare professionals and entities responsible for public and private hospitals carry the same immediate reporting duty. When the Agency receives a report from a healthcare professional or patient, it forwards that information to the manufacturer, who then investigates. PMS Plans, PMS Reports and PSURs all follow the same MDR Annex III framework in Denmark as anywhere else in the EU. Denmark does not run a parallel PMS documentation format.

Conclusion

Denmark operates fully inside the EU MDR and IVDR system. CE marking is what puts a device on the market here. National obligations on top of that are Danish-language labelling, a genuine registration duty for operators established in Denmark and ongoing incident reporting once the device is live.

If you need support with medical device registration, CE marking, technical documentation, Danish Medicines Agency requirements, or EU market entry, reach out to the experts at info@artixio.com for guidance tailored to your product and market entry goals.

FAQs

Q1. Is medical device registration required in Denmark?

Not in the sense of a pre-market government approval for the device itself. Medical devices do not require approval by the authorities before they can be marketed in Denmark, and the Danish Medicines Agency states directly that it does not approve medical devices. What does apply is CE marking, correct classification and, for manufacturers, Authorised Representatives, importers, distributors, or specialty stores actually established in Denmark, mandatory registration with the Danish Medicines Agency’s own database.

Q2. Does Denmark require CE marking for medical devices?

Yes. The CE mark shows that the device meets the applicable requirements of the EU regulations and the Danish executive orders, and that it has been subjected to a conformity assessment procedure. Without valid CE marking, a device cannot legally be placed on the Danish market.

Q3. Do non-EU medical device manufacturers need an EC REP in Denmark?

Yes, but this comes from EU law, not a Denmark-specific rule. Any non-EU manufacturer placing a device on any EU market, including Denmark, must appoint an EU Authorised Representative under MDR Article 11.

Q4. What are the Denmark Medical Device Labelling Requirements?

Labelling and instructions for use must be in Danish when the device is made available to the final user or patient in Denmark, under section 3(1) and section 4(1) of the Executive Order on medical devices, alongside the standard MDR Annex I labelling content requirements that apply across the EU.

Q5. What are the Denmark Medical Device Registration Fees?

A certificate of free sale costs DKK 1,362 per certificate in 2026. Beyond that, there is no single flat registration fee. A registration fee applies only to manufacturers and Authorised Representatives of Class I, custom-made, IVD and system or procedure pack devices; Class IIa, IIb and III manufacturers and ARs are exempt from it. A separate annual supervision fee applies to manufacturers, Authorised Representatives, importers and distributors, scaled by actor role, risk class and company size.