Authorised Representative services for medical device manufacturers across the EU, UK, and Switzerland
EUMEDIQ provides Authorised Representative services for medical device and in vitro diagnostic manufacturers outside the European Union, United Kingdom, and Switzerland, enabling compliant market access across all three jurisdictions through a single, fully digitalised service engagement.
1 SERVICE PROVIDER, 3 MARKETS
Your legally designated point of contact with competent authorities
EUMEDIQ manages Authorised Representative obligations across Switzerland, the European Union, and the United Kingdom under a single mandate, with one dedicated contact overseeing all three jurisdictions. Our fully digitalised and paperless processes, combined with integrated expertise across regulatory affairs, quality management, and auditing, deliver compliant market access with the least possible administrative burden on your organisation, supported by a transparent and proportionate cost structure throughout.
Highly automated and paperless
Highly digitalised registration processes backed by integrated expertise across regulatory affairs, quality management, and auditing.
One provider across three jurisdictions
A single mandate and one named contact cover all Authorised Representative obligations across the EU, UK, and Switzerland.
End-to-end regulatory support
Importer monitoring, auditing, direct coordination on complaints and post-market events, and ongoing compliance management.
YOUR MARKET ACCESS
A structured and transparent path to market access
EUMEDIQ manages every step of the Authorised Representative process on behalf of the manufacturer, from the initial non-disclosure agreement and technical documentation review through to Competent Authority notifications, regulatory database registrations, and ongoing post-market compliance management.
The process is designed to be as efficient and straightforward as possible, with a dedicated EUMEDIQ contact guiding the manufacturer through each phase and managing all interactions with Competent Authorities, Notified Bodies, and regulatory databases across the EU, UK, and Swiss markets.
STEPS TO MARKET
STEP 1 (OPTIONAL)
Non-Disclosure Agreement
EUMEDIQ executes a non-disclosure agreement prior to the review or exchange of any manufacturer documentation, ensuring full confidentiality from the outset of the engagement.
STEP 2
Quote and Service Agreement
EUMEDIQ provides a detailed quote and service agreement templates, outlining the full scope of services, responsibilities, and cost structure for review and approval by the manufacturer.
STEP 3
Technical documentation review
EUMEDIQ conducts a structured review of the manufacturer's technical documentation to assess readiness for market registration across the relevant jurisdictions.
STEP 4 (OPTIONAL)
Supplier qualification
EUMEDIQ is formally qualified as a supplier in accordance with the manufacturer's quality management system, fulfilling the QMS requirements applicable to the appointment of an Authorised Representative.
STEP 5
Competent authority registration
Labelling is reviewed and released with EUMEDIQ designated as Authorised Representative, ensuring all labelling requirements applicable to the target markets are correctly reflected.
STEP 6 (EU REP ONLY)
EC certificate
The manufacturer's EC certificate or Declaration of Conformity is updated to include EUMEDIQ's information as Authorised Representative, in accordance with the MDR requirements and regulatory frameworks.
EUMEDIQ VAULT
Secure technical documentation exchange and storage across your markets
EUMEDIQ Vault is an exclusive, ISO 27001-certified document exchange and storage platform, developed to provide manufacturers with a secure, centralised, and always-accessible system for technical documentation management across all EUMEDIQ-supported markets. It operates as a single system covering Switzerland, the European Union, and the United Kingdom, replacing the need for separate documentation management solutions across each jurisdiction.
All technical documentation is stored and exchanged within a closed, access-managed environment that meets the information security requirements of regulated medical device manufacturers. Manufacturers retain full and unrestricted access to their documentation at all times, with complete visibility over every document held within the system throughout the duration of the engagement.
One system across your markets
A single platform covering Switzerland, the EU, and the UK, eliminating the need for separate documentation systems across each jurisdiction.
ISO 27001-certified platform
State-of-the-art information security standards applied across every document transfer, storage operation, and access request within the platform.
Full access at all times
Customers retain full and unrestricted access to their technical documentation, with complete visibility over every document held within the system.
ONE COORDINATED MANDATE
Local presence in every jurisdiction we serve as Authorised Representative
Each regulatory jurisdiction requires the Authorised Representative to be physically established within that market. EUMEDIQ maintains dedicated legal entities in Switzerland, Germany, and the United Kingdom, providing manufacturers with a compliant and locally established representative in each of their target markets.
United Kingdom
The UK Responsible Person fulfils all MHRA obligations on behalf of the outside-UK manufacturer, including device database registration and UKCA marking requirements for the Great Britain market.
EUMEDIQ Ltd.
London, UK
Switzerland
Mandatory under MedDO Article 52 for manufacturers outside Switzerland, covering Swissmedic representation, swissdamed registration, and ongoing compliance obligations under MedDO and IvDO Article 44.
EUMEDIQ AG
Zug, Switzerland
European Union
Mandatory under MDR 2017/745 and IVDR 2017/746 for manufacturers outside the EU, covering EUDAMED registration, technical documentation access, and Competent Authority correspondence under Article 11.
EUMEDIQ GmbH
Hardt, Germany
MEDICAL DEVICE COMPLAINTS
Report a medical device complaint or safety concern
EUMEDIQ is required to maintain a medical device complaint register as part of its Authorised Representative mandate.
Use this form to report a complaint or safety concern related to a medical device for which EUMEDIQ acts as Authorised Representative/Responsible Person