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Medical & IVD Device Compliance for the EU and UK
End-to-End EU MDR & UK Regulatory Compliance — Including EU Authorised Representative, EUDAMED, HPRA & MHRA Registration
Trusted by Regulators & Authorities
What We Do
Compliance & Representative Services for Medical Devices and IVDs in the EU & UK
EU Authorised
Representative (EU AR)
We act as your official EU Authorised Representative under MDR 2017/745 and IVDR 2017/746. Euverify (Ireland) serves as your legal point of contact for EU authorities, manages regulatory communication, supports vigilance and incident reporting obligations, and maintains your technical documentation as required.
UK Responsible Person (UK RP)
Euverify Ltd (London) acts as your UK Responsible Person under the UK MDR 2002. We register your devices with the MHRA, hold and verify your technical documentation, liaise with UK regulators, and support post-market and safety communication requirements.
EUDAMED & MHRA Registration
We handle all EUDAMED and MHRA registrations for manufacturers and devices. Our team prepares the required data, uploads UDI-DI information, and ensures your product listings are correctly validated and traceable.
Technical File Review & Gap Assessment
We review your Technical Documentation as required by MDR Annex II & III or IVDR Annex II. This includes checking your device description, manufacturing information, risk files, verification data, clinical/performance evidence, and your GSPR checklist to identify any compliance gaps.
Risk Management & Clinical Evaluation Review
We review your Risk Management documentation (ISO 14971:2019) and assess your Clinical Evaluation Reports (CER) or Performance Evaluation Reports (PER) for IVDs to ensure they meet MDR/IVDR requirements and identify any gaps.
Label, IFU & Packaging Review
We review your labels, IFUs, and packaging to ensure they meet MDR/IVDR requirements, including mandatory symbols, warnings, UDI/Basic UDI-DI, manufacturer/AR/RP details, and language obligations for EU and UK markets.
UDI & Basic UDI-DI Creation
We help you assign and manage UDI-DI and UDI-PI codes, generate Basic UDI-DI records, and prepare the dataset for EUDAMED upload ensuring traceability across EU and UK markets.
GMDN & Device Coding
We support you in identifying and validating the correct GMDN codes for your devices. Accurate coding helps align your registrations with EUDAMED and MHRA device databases.
Post-Market Surveillance & Vigilance Support
We review your PMS Plans, PMS Reports, and PSURs, and support you with vigilance obligations, including incident reporting and Field Safety Corrective Actions (FSCAs), to ensure ongoing MDR/IVDR compliance.
HPRA Notification & Annual Renewals
We support you in identifying and validating the correct GMDN codes for your devices. Accurate coding helps align your registrations with EUDAMED and MHRA device databases.
Testing & Validation Support
We connect you with accredited laboratories for biocompatibility (ISO 10993), electrical safety (IEC 60601), software lifecycle (IEC 62304), and performance testing to strengthen your technical documentation.
Who Needs a Medical
/ IVD Representative?
If you are manufacturing or importing medical devices into the EU or UK, you must legally appoint an EU Authorised Representative and/or UK Responsible Person.
You need representation if you are a:
- Non-EU or non-UK manufacturer placing Class I, Is, Im, Ir devices
- Distributor or importer selling under your own name
- Private label or OEM supplier
Legal Requirement: Under MDR 2017/745, IVDR 2017/746, and UK MDR 2002, manufacturers outside the EU/UK must appoint a local representative.
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Device Classes We Support
Comprehensive support across all medical device and IVD classifications.
Have a Class II / III or B–D IVD?
Submit your documentation and Notified Body certificate for eligibility review.
Class I / Is / Im / Ir
Full Support
Non-sterile & low-risk devices (e.g., stethoscopes, dressings)
- Full service (AR / RP + Registration + Docs)
Class IIa & IIb
Conditional
Medium-risk (e.g., infusion pumps, contact lenses)
- Supported if Notified Body certificate & CE mark are available and documentation is complete.
Class III
Case-by-Case
High-risk (e.g., implants, pacemakers)
- Accepted case-by-case with Notified Body certificate and full technical file review.
IVD Class A
Full Support
General lab devices / collection kits
- Full support
IVD Class B–D
Conditional
Moderate to high-risk diagnostics (e.g., HIV tests)
- Conditional support with Notified Body certificate
How It Works (Onboarding Process)
Simple, streamlined onboarding process to get you compliant quickly
Choose plan and sign agreements
Select the service package that fits your needs and complete the necessary agreements.
Upload technical files & labels
Securely upload your device documentation, technical files, and labeling materials.
Euverify reviews documentation
Our experts conduct a thorough review and gap assessment of your submission.
EUDAMED / MHRA Submissions
We prepare and submit all necessary registrations to the appropriate authorities.
Receive official registration confirmation
Get your compliance certificates and official registration confirmations.
Complete compliance in as little as 2–3 weeks
Our streamlined process ensures fast turnaround without compromising quality.
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You’re in Safe Hands
Professional compliance services backed by expertise, security, and regulatory excellence
EU & UK Registered
Physical presence in Ireland and London ensuring local regulatory expertise and compliance.
Certified Compliance Specialists
Our team holds certifications in MDR, IVDR, and regulatory affairs with years of experience.
Secure Storage & Monitoring
Enterprise-grade security for your technical documentation with 24/7 system monitoring.
Full Regulatory Protection
Complete coverage for vigilance reporting, authority correspondence, and compliance management.
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.
A UK Responsible Person (UKRP) is required for manufacturers placing devices on the Great Britain (England, Scotland and Wales) market under the UK Medical Devices Regulations. While the roles are similar, they operate under different legal frameworks and are not interchangeable.
Yes — if you plan to sell in both markets.
- EU market → EU Authorised Representative required
- Great Britain market → UK Responsible Person 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
- UK (MHRA): usually 1–4 weeks
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. Euverify 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.
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