EU Authorised Representative & UK Responsible Person for IVDs and Medical Devices

Frequently Asked Questions about EU & UK Representative Services

• Do I need both a UKRP and an EU Authorised Representative?

  Yes, if you intend to place your medical device or IVD on both the Great Britain and the European Union markets. These are two separate legal appointments under two distinct regulatory frameworks: the UKRP is required under UK MDR 2002 (as amended) for the GB market, while the EU Authorised Representative is required under Article 11 of MDR and IVDR for the EU market. Northern Ireland follows the EU framework under the Windsor Framework, so an EU AR covers NI placement. MDx CRO is one of few providers able to act as both UKRP and EU AR under a single service agreement, simplifying governance and ensuring coordinated vigilance reporting across jurisdictions.

• How long does it take to appoint an EU AR or UKRP?

  Once we receive the signed mandate and complete technical documentation, MDx typically finalises the appointment and initiates regulatory registrations within 5 to 15 business days. Timelines depend on device risk class, completeness of technical documentation, and the responsiveness of the relevant competent authority. EUDAMED actor registration for EU AR services can be completed within days once documentation is verified, while MHRA device registration under UKRP obligations follows MHRA’s statutory processing times. For urgent market-entry projects, MDx offers an expedited onboarding pathway that compresses internal review steps without compromising regulatory due diligence.

• What documents are required to appoint MDx as EC-REP?

  To formalise the appointment of MDx as your EC-REP (EU Authorised Representative), we require: a signed Mandate Agreement defining the scope and duration of representation; the Declaration of Conformity for each device covered; the complete technical documentation (Annex II and III of MDR/IVDR); evidence of conformity assessment by a Notified Body where applicable; the Instructions for Use (IFU) and labelling in the required EU languages; the manufacturer’s ISO 13485 certificate (or equivalent QMS evidence); and UDI-DI information for EUDAMED registration. For IVDs, we additionally request the performance evaluation report and summary of safety and performance (SSP) where applicable. MDx provides a structured onboarding checklist to streamline document collection.

• Can one company act as both my EU AR and UKRP?

  Yes, a single legal entity can act as both your EU Authorised Representative and UK Responsible Person, provided the entity has a registered presence in both jurisdictions — which MDx does through our EU offices (Barcelona, Madrid, Lisbon) and our UK office (London). Consolidating both roles with one partner is increasingly common among non-EU and non-UK manufacturers because it simplifies contract management, harmonises vigilance and post-market surveillance reporting, and ensures consistent handling of Field Safety Corrective Actions (FSCAs) across both markets. Legally, the two roles remain separate appointments under separate regulations, but they can be delivered under a single integrated service agreement.

• What happens if I don't appoint an EU Authorised Representative?

  Placing a medical device or IVD on the EU market without an appointed EU Authorised Representative is a regulatory breach under MDR and IVDR for non-EU manufacturers. Consequences include: refusal of customs clearance and import rejection; removal of the device from the EU market by competent authorities; financial penalties that vary by Member State but can reach significant amounts; suspension or withdrawal of CE marking in cases of repeated non-compliance; and potential liability exposure in the event of an incident involving a patient or user. Importers and distributors are also legally required to verify that a valid EU AR has been appointed before placing a device on the market, meaning supply-chain partners will refuse to handle non-compliant products.

• How much does an EU AR service typically cost?

  EU AR service fees vary based on several factors: device risk class (Class I vs. Class III, or IVD Class A vs. Class D), number of devices or device families covered under the mandate, scope of additional services (vigilance handling, EUDAMED management, PMS support, Notified Body liaison), and complexity of the technical documentation requiring ongoing review. Most providers structure fees as an annual retainer covering baseline representation obligations, with additional fees for specific activities such as incident reporting, FSCAs, or regulatory submissions. MDx CRO offers transparent, scope-based pricing and provides a tailored quotation following an initial assessment of your device portfolio. Contact us for a customised proposal.

• What's the difference between an EC-REP and a Legal Representative?

  The two roles are often confused but serve distinct regulatory purposes. An EC-REP (EU Authorised Representative) is appointed under Article 11 of MDR/IVDR by a non-EU manufacturer to place finished, CE-marked devices on the EU market. Their responsibilities include verifying conformity, managing EUDAMED registration, and handling vigilance and post-market surveillance. A Legal Representative is appointed under MDR Article 62 or IVDR Article 58 by a non-EU sponsor conducting clinical investigations or performance studies in the EU. Their role is to ensure the sponsor complies with trial-related obligations, liaise with National Competent Authorities and Ethics Committees, and assume legal accountability for study conduct within the EU. A manufacturer running a pre-market clinical investigation would typically need a Legal Representative; once the device receives CE marking and is placed on the market, an EC-REP is also required. MDx CRO provides both services under a unified regulatory framework.