Trusted EU & UK Regulatory Representation for Market & Clinical Access
Appoint MDx CRO as your EU Authorised Representative, UK Responsible Person, or Legal Representative to ensure compliant, efficient market entry and clinical study execution under IVDR, MDR, CTR, and UK MDR.
One partner—full regulatory accountability.
MDx CRO offers full-scope regulatory representation services
We ensure seamless market access and clinical compliance across the EU & UK for IVDs, medical devices, and clinical trial sponsors.
We act as:
- EU Authorised Representative (EU AR)
- UK Responsible Person (UKRP)
- Legal Representative for EU clinical trials (CTR, IVDR & MDR)
- UK Legal Representative (UKRP) for MHRA-regulated clinical studies
Each service is delivered with full regulatory accountability, direct liaison with competent authorities, and compliance with IVDR, MDR, CTR, and UK MDR frameworks.
EU Authorised Representative (EU AR)
For non-EU manufacturers of IVDs and medical devices (Article 11 of IVDR/MDR), the EU AR ensures that products meet regulatory obligations before entering the EU market.
Our Role Includes:
- Registration in EUDAMED
- Verification of CE marking and Annex I GSPR compliance
- Vigilance reporting and Post-Market Surveillance (PMS) support
- Liaison with Notified Bodies and Competent Authorities
- Document retention, including the Declaration of Conformity
UK Responsible Person (UKRP)
For non-UK manufacturers post-Brexit (UK MDR 2002), the UKRP is mandatory for placing devices and IVDs on the GB market.
Our Role Includes:
- Device registration with the MHRA
- Review of UK-specific technical documentation
- IFU and labeling compliance (UKCA)
- Vigilance reporting and PMS facilitation
- Acting as the point of contact with the MHRA
Legal Representative for EU Clinical Trials
For non-EU sponsors conducting IVD and medical device research in Europe
Under IVDR Article 58 and MDR Article 62, sponsors based outside the EU must appoint a Legal Representative located in the EU to conduct IVD performance studies or medical device clinical investigations. MDx acts as Legal Representative for the device/diagnostic side.
We support:
UK Legal Representative for Clinical Investigations
For non-UK sponsors conducting studies under UK MDR
A UK-based Legal Representative (UK RP) is required for clinical investigations or performance evaluations submitted to the MHRA.
We Support:
| Feature |
|---|
| IVDR & MDR Representation |
| Dual EU + UK Coverage |
| Clinical Study Compliance |
| Combined Study Support (IVDR + CTR) |
| Direct Communication with Authorities |
| Comprehensive Regulatory Support |
| MDx CRO | Standard Agents |
|---|---|
 Legal Representative services for IVD and medical device studies |  Often limited to product registration only |
| EU AR, UKRP, and legal rep services for EU & GB | Typically EU or UK, not both |
| Legal Representative for IVDR Article 58 and MDR studies |  Rarely support study-related obligations |
| Legal Representative for the IVD component in combined trials | Do not support IVD roles in dual-pathway trials |
| Interface with NCAs, MHRA, EUDAMED, and Ethics Committees | Often indirect or outsourced |
| Covers pre-market access, submissions, and post-market surveillance | Focused only on device registration |
Frequently Asked Questions
Ask us a Question- Is a Legal Representative required for EU clinical studies?
Yes. Non-EU sponsors must appoint a Legal Representative established in the EU to conduct performance studies under the IVDR or clinical investigations under the MDR. MDx fulfills this role and supports submissions to National Competent Authorities and Ethics Committees.
- What’s the difference between an EU Authorised Representative and a Legal Representative?
An EU Authorised Representative (EU AR) is required for placing devices on the EU market. A Legal Representative is required for conducting clinical studies (IVDR/MDR) in the EU by non-EU sponsors. MDx provides both services, ensuring consistent oversight throughout pre-market and study phases.
- Do I need both a UKRP and a UK Legal Representative?
No. Unlike the EU, the UK does not require a separate Legal Representative for clinical investigations. However, non-UK manufacturers must appoint a UK Responsible Person (UKRP) to place devices or IVDs on the GB market. For clinical studies, while the UKRP is not legally required to support the trial, MHRA expects agreements between the device manufacturer and a UKRP, and MDx can act as your UKRP and provide regulatory support for UK-based studies.
- Q4: What is required to appoint MDx as an EU AR, UKRP, or Legal Representative?
We will request:
- A signed service agreement outlining responsibilities
- Product and device scope
- Access to up-to-date technical documentation
- Sponsor or manufacturer contact points for regulatory communication
- Does MDx handle EUDAMED and MHRA registrations?
Yes. We manage actor registration, UDI/device listings, and technical file updates in EUDAMED. We also register devices and manage submissions with the MHRA, including vigilance and post-market reporting under IVDR, MDR, and UK MDR.
Ensure EU and UK Market Access with Trusted Representation
MDx offers integrated representation for product approvals and clinical trials under IVDR, MDR, CTR, and UK MDR. Ensure compliance with a partner that understands both market and clinical obligations.
One partner. Dual representation. Total regulatory confidence.
