Sell Your Medical & IVD Devices Legally in the EU
We support manufacturers and importers of Class I medical devices and in vitro diagnostic devices with registration, EU authorised representation, and ongoing compliance with MDR, IVDR, and applicable local authority requirements.
Trusted by Regulators & Authorities
What We Do
Regulatory Compliance and Authorised Representation Services for Medical Devices and IVDs in the EU and UK.
EU Authorised Representative (EU AR)
We serve as your officially appointed EU Authorised Representative in compliance with MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Our Ireland-based entity acts as your designated contact for EU competent authorities, handles regulatory communications, supports vigilance and incident reporting requirements, and ensures the maintenance of all required technical documentation.
EUDAMED & MHRA Device Registration
We take care of registering manufacturers and medical devices with EUDAMED and the MHRA.
Our specialists compile and submit the necessary details, enter UDI-DI information, and confirm that all device entries are accurate, traceable, and aligned with regulatory standards.
Technical Documentation Evaluation & Compliance Gap Analysis
We assess your technical files against the requirements of MDR Annex II & III or IVDR Annex II.
Our review examines product specifications, production details, risk management documentation, verification and validation evidence, clinical or performance data, and the GSPR requirements to pinpoint and resolve any areas of non-compliance.
Risk Management and Clinical / Performance Assessment
We evaluate your risk management files in line with ISO 14971:2019 and review Clinical Evaluation Reports (CER) or, for IVDs, Performance Evaluation Reports (PER).
This assessment confirms compliance with MDR and IVDR requirements and highlights any deficiencies that require remediation.
Labeling, IFU and Packaging Compliance Check
We assess your product labels, instructions for use, and packaging materials to confirm conformity with MDR and IVDR regulations.
Our review covers required symbols and safety statements, UDI and Basic UDI-DI information, manufacturer and Authorised Representative or Responsible Person details, as well as all applicable language obligations for both EU and UK markets.
UDI & Basic UDI-DI Setup and Management
We assist with generating and maintaining UDI-DI and UDI-PI identifiers, establish Basic UDI-DI entries, and compile the necessary data packages for EUDAMED registration—ensuring complete product traceability across both EU and UK markets.
GMDN Classification & Device Coding Support
We help determine and confirm the appropriate GMDN codes for your medical and IVD products.
Correct classification ensures accurate device registration and proper alignment with EUDAMED and MHRA regulatory databases.
Post-Market Monitoring & Vigilance Assistance
We evaluate your Post-Market Surveillance (PMS) strategies, ongoing PMS reports, and Periodic Safety Update Reports (PSURs).
In addition, we provide support with vigilance obligations, including adverse event reporting and Field Safety Corrective Actions (FSCAs), helping you maintain continued compliance with MDR and IVDR regulations.
HPRA Device Notification & Renewal Management
We assist with HPRA notifications and yearly renewals for medical devices and IVDs placed on the Irish market.
Our specialists compile and file the necessary documentation, monitor renewal timelines, and support the continued legal registration of your products with the HPRA.
Testing and Verification Assistance
We coordinate access to certified laboratories for biocompatibility assessments (ISO 10993), electrical safety testing (IEC 60601), software lifecycle validation (IEC 62304), and performance evaluations to enhance and support your technical documentation.
Who Requires a Medical Device / IVD Representative?
Any company manufacturing or bringing medical devices or IVDs into the EU market is legally required to appoint an EU Authorised Representative.
You will need an appointed representative if you are:
A manufacturer based outside the EU or UK placing Class I, Is, Im, or Ir devices on the market
A distributor or importer marketing devices under your own brand name
A private label manufacturer or OEM supplier
Legal obligation: In accordance with MDR (EU) 2017/745, IVDR (EU) 2017/746, and UK MDR 2002, manufacturers located outside the EU must designate an authorised local representative.
Request a Quote
Let us know how many devices you plan to register and the EU markets you wish to access. We’ll prepare a customised quotation and send you a detailed pricing breakdown by email, including any applicable volume or bundled discounts.
How It Works (Onboarding Journey)
A clear and efficient onboarding pathway designed to help you achieve
compliance quickly and smoothly.
Select a plan &
formalise agreements
Choose the service option that best suits your requirements and complete the required contractual documentation.
Submit technical
documentation & labels
Safely upload your device files, technical documentation, and labeling artwork through our secure system.
Documentation review
by Complico Consulting
Our regulatory specialists carry out a detailed review and compliance gap analysis of your submission.
EUDAMED / MHRA
registrations
We compile and submit all required registrations to the relevant regulatory authorities.
Official registration confirmation
Receive formal confirmation of registration and compliance documentation.
Compliance achieved in as little as 2–3 weeks
Our optimised process delivers rapid turnaround while maintaining high regulatory standards.
Schedule a Discovery Call
Not sure how to begin with GPSR compliance?
Chat with our specialists to learn what’s needed for EU & UK markets and how Euverify makes compliance straightforward.
Trusted & Secure
EU & UK Presence
Registered offices across Germany and the United Kingdom
Cosmetics Compliance Specialists
Deep expertise in EC No. 1223/2009 and UK Cosmetics Law.
Qualified Toxicology Experts
CPSR Parts A & B prepared by certified toxicologists.
Inspection-Ready Documentation
Complete, inspection-ready documentation at all times.
Frequently asked questions
An EU Authorised Representative (EU AR) is legally required for non-EU manufacturers placing medical devices on the EU market under the EU MDR or IVDR. The EU Authorised Representative acts as the manufacturer’s regulatory contact within the EU.
Yes — if you plan to sell in both markets.
• EU market → EU Authorised Representative required
Manufacturers selling in only one region require representation only for that specific market.
Timelines depend on device class, documentation readiness and regulatory authority workload.
• EU (EUDAMED or national authority): typically 2–6 weeks after submission
Delays may occur if documentation is incomplete or requires clarification.
Support generally includes:
• Medical Devices: Class I, IIa, IIb, III
• In Vitro Diagnostic Devices (IVDs): Class A, B, C, D
The applicable conformity assessment route depends on the device classification and intended use.
Commonly required documents include:
• Device description and intended use
• Risk management file
• Technical documentation or summary
• Declaration of Conformity
• Labelling and Instructions for Use (IFU)
• Quality management system evidence (where applicable)
• UDI information (if assigned)
Additional documents may be required depending on device class and whether MDR or IVDR applies.
• EUDAMED: Registration is completed through the EUDAMED portal by the manufacturer or their EU Authorised Representative.
• MHRA: Registration is completed via the MHRA Device Online Registration System (DORS) by the UK Responsible Person.
Each system requires validated user accounts and accurate device data submission.
Yes. All medical devices, including Class I devices, must have a clinical evaluation demonstrating safety and performance.
For many Class I devices, this can often be based on existing clinical data and scientific literature, rather than new clinical investigations.
Manufacturers must maintain an ongoing post-market surveillance (PMS) system, which includes:
• Monitoring device performance after placing it on the market
• Collecting and evaluating complaints and incidents
• Reporting serious incidents to regulatory authorities
• Periodic review and updating of technical documentation
These obligations apply throughout the entire lifecycle of the device.
Incomplete or inaccurate documentation may result in:
• Delays to registration
• Requests for additional information
• Rejection or suspension of the submission
• Potential regulatory non-compliance if devices are already on the market
Ensuring documents are complete before submission helps prevent delays and enforcement action.
Yes. Complico Consulting can support both MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) submissions, including regulatory representation, registration management and compliance support across EU and UK markets.