MDR/ IVDR EU Importer Service
Trusted by 250+ medical device and IVD manufacturers across 20 countries
✓ Stay in control of EU MDR/IVDR importer obligations
✓ Full Article 13 verification and record-keeping managed remotely
✓ Direct access to your dedicated regulatory contact (no generic inboxes)
✓ Transparent, flat-fee pricing with no hidden costs
New to EU Importer requirements? Learn more below ↓
EU Importer Service for Medical Devices
The EU MDR and IVDR introduced ‘importers’ as a defined economic operator role, with specific legal obligations outlined in Article 13.
When a device manufactured outside the EU first enters the EU market, the party receiving that shipment automatically becomes the importer. They then take on those MDR/IVDR obligations, whether they are aware of them or not.
That default position creates risk. Your EU customer may suddenly find themselves responsible for verifying that your devices are CE marked, that labeling is compliant, and that you and your devices are correctly registered in EUDAMED. They must also register themselves in EUDAMED, apply their contact details to the device, maintain traceability records, and keep a register of complaints. These are obligations your commercial partner may not be set up to handle, nor willing to accept.
Appointing Casus as your regulatory importer keeps the process controlled on your terms. We conduct all required compliance checks remotely, so your supply chain and logistics remain unchanged.
NOTE: The importer role is separate from the EU Authorized Representative (EC REP).
MDR/IVDR Article 13 Importer Obligations
Our EU importer service for medical devices and in vitro diagnostics covers all MDR/IVDR Article 13 obligations. We act as your EU‑based regulatory importer while you continue using your existing distributors, logistics providers, and Importer of Record for customs.
Before your devices are placed on the EU market, the importer must confirm that:
- The device has been CE marked and a Declaration of Conformity has been drawn up.
- The manufacturer has been identified, and an EU Authorized Representative has been designated.
- Device labeling and instructions for use comply with the MDR/IVDR (including translations, as applicable).
- Where required, a UDI has been assigned by the manufacturer.
- The importer’s name and address are indicated on the device label, packaging, or document accompanying the device.
- The devices have been registered in EUDAMED.
- While a device is under their responsibility, storage and transport conditions do not compromise compliance with the device’s general safety and performance requirements.
- Importer EUDAMED registration is linked to Manufacturer EUDAMED registration.
In addition to pre-market verification, the importer has ongoing obligations:
- Maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
- Forward complaints from healthcare professionals, patients, or users to the manufacturer and EU Authorized Representative.
- Cooperate with competent authorities and inform them if a device is believed to be non-conforming or poses a serious risk.
- Keep declarations of conformity and certificates available for inspection.
EU Virtual Regulatory Importer Service
Casus acts as a virtual regulatory importer. We fulfill all Article 13 obligations remotely, without taking physical possession of your devices and without disrupting your existing shipping arrangements. Your supply chain remains exactly the same.
What We Verify for Each Shipment
- CE marking and Declaration of Conformity are in place
- EU Authorized Representative is correctly identified and designated
- Labeling and IFU comply with the applicable regulation
- UDI is assigned where required
- Importer contact details are on the label or packaging
- EUDAMED registration is current (and is linked to our EUDAMED Importer registration)
Ongoing Obligations We Manage
- Complaint and vigilance record-keeping
- Forwarding of reported incidents or complaints to you and your EU Authorized Representative
- Coordination with competent authorities if required
- Availability of conformity documentation for inspection
How Our MDR/IVDR Importer Service Works
Streamlined onboarding with no disruption to your sales channels.
- Contract & Onboarding (1-3 days): Sign your EU Importer agreement and provide your device documentation. We align on your shipment schedule and verification workflow from the start.
- Documentation Review (3-5 business days): We review your labeling, Declaration of Conformity, UDI assignment, and EUDAMED registration status for each device. We will flag any gaps before your first shipment.
- Shipment Verification: For each shipment, you notify us in advance. We complete the required Article 13 verification checks and confirm clearance. Your shipment proceeds through your normal logistics route.
- Ongoing Support: Direct access to your dedicated regulatory team for label updates, EUDAMED changes, vigilance coordination, and any competent authority interactions.
Why Manufacturers Choose Casus
Regulatory Expertise, Not Just a Name on a Label: Our team has deep experience with EU MDR and IVDR compliance across device classes. We understand what we are verifying and why. We ensure that every shipment is checked and documented against regulatory requirements. This protects you by keeping your compliance record clean and reducing your exposure if a device is ever questioned by a competent authority.
No Supply Chain Disruption: We operate as a virtual importer. You ship as you always have. We complete our verification obligations remotely and confirm clearance before your shipment departs.
Coordinated with Your EC REP: If Casus also serves as your EU Authorized Representative, we coordinate both roles under a unified account. This means one point of contact, and a team that already knows your devices and documentation.
Transparent, Fair Pricing: No hidden fees or per-shipment surprise charges. We provide clear pricing from the start, and we do not penalize you for growing your product portfolio with us.
Responsive, Accessible Team: Direct access to your regulatory contacts: no ticketing systems, no intermediaries, no junior staff handling your compliance questions. When something time-sensitive comes up, you can reach us.
Proven Track Record: Trusted by 250+ medical device and IVD manufacturers across 20 countries for EU, UK, and Swiss regulatory representation services.
Frequently Asked Questions
Is an EU Importer required under the MDR and IVDR?
The regulations do not require manufacturers to appoint a specific importer, but they do define the importer’s role and assign obligations to it. If no importer is identified, the party receiving the shipment in the EU becomes the importer by default and takes on those legal obligations. This is whether or not they are aware of, or willing to, accept them. For most manufacturers, identifying and appointing a regulatory importer is a practical way to ensure their supply chain is meeting its regulatory obligations.
Is an EU Importer the same as an Importer of Record (IOR)?
No, not necessarily. The two roles are distinct, although the same company can sometimes perform both.
The Importer of Record (IOR) is a customs concept: it is the legal entity responsible for import declarations, duties and taxes, and customs‑related documentation when goods enter the EU.
The EU Importer under the MDR/IVDR is a regulatory concept: a natural or legal person established in the EU who places a device from a third country on the Union market for the first time and fulfils specific compliance duties, including verification of CE marking, UDI and labeling, registration, and more.
Casus acts as your MDR/IVDR regulatory importer only and does not act as your customs IOR, i.e., Casus does not assume responsibility for customs declarations, payment of duties/VAT, or other IOR activities. You will still need a suitable IOR solution (for example, a logistics provider, customs broker, distributor, or specialist IOR service) for the physical import of your devices into the EU.
Does the importer need to physically receive the devices?
No. The MDR and IVDR do not require the regulatory importer to take physical possession of the devices. Casus operates as a virtual importer, completing all verification obligations remotely. Physical control of the devices stays with your logistics chain.
Does the importer’s name need to be on the label?
Yes. The importer’s name and address must appear on the device label, packaging, or a document accompanying the device. Casus will provide you with the required contact information to include on your labeling at the time of onboarding.
Can Casus act as both our EC REP and our EU Importer?
Yes. Casus provides both EU Authorized Representative (EC REP) and EU Importer services. Having a single provider for both roles simplifies coordination and reduces the administrative overhead of managing two separate regulatory relationships.
What happens if a shipment has a compliance issue?
If we identify a gap during our pre-shipment verification (e.g., missing UDI, labeling that does not include importer details, out-of-date EUDAMED registration), we will contact you directly to resolve it before the shipment is cleared. We document all verification activity and keep records in line with our MDR/IVDR obligations.
Ready to Appoint an Importer?
Get your custom quote and timeline for EU Regulatory Importer services. Our team will assess your specific requirements and provide transparent pricing.
Questions about EU importer requirements? Contact our team.
