Your Regulatory Presence in Europe, Switzerland & India

Through its presence and regulatory network, ELLECOM provides EU Authorised Representative (EU-REP), Swiss Authorised Representative (CH-REP), and Indian Authorised Agent services for medical device and IVD manufacturers seeking access to these markets.

Our role extends beyond providing a local address. We work with manufacturers throughout the regulatory lifecycle from establishing representation and reviewing regulatory documentation to registration activities, authority communication, vigilance coordination, and ongoing regulatory compliance.

  • Under Article 11 of the EU MDR 2017/745 and EU IVDR 2017/746, a manufacturer established outside the European Union must designate a sole Authorised Representative before placing its devices on the Union market.

    ELLECOM GmbH, established in Germany, provides EU Authorised Representative services for non-EU manufacturers of medical devices and IVDs.

    As EU-REP, ELLECOM acts under a written mandate and performs the applicable responsibilities assigned to the Authorised Representative under the MDR or IVDR.

  • Our activities include verification that the EU Declaration of Conformity and technical documentation have been drawn up and, where applicable, that the appropriate conformity assessment procedure has been completed.

    We support manufacturers with regulatory documentation and labeling requirements, economic-operator and device registration activities, communication with competent authorities, and coordination of applicable vigilance and post-market regulatory obligations.

    The EU-REP also maintains the required documentation available for competent authorities and forwards relevant complaints or reports received from healthcare professionals, patients, or users to the manufacturer.

  • A manufacturer is not permanently tied to its existing EU-REP.

    Article 12 of the MDR and IVDR establishes requirements concerning a change of Authorised Representative, including arrangements between the manufacturer and, where practicable, the outgoing and incoming representatives.

    ELLECOM can coordinate the regulatory transition, review the existing representation arrangement and device portfolio, establish the new mandate, support the required registration and labeling changes, and coordinate the transition documentation necessary to maintain regulatory continuity.

  • Your Regulatory Presence in Switzerland

    Manufacturers established outside Switzerland may be required to appoint an authorised representative established in Switzerland before their devices can be placed on the Swiss market.

    Swissmedic defines the CH-REP as a natural or legal person established in Switzerland that has received and accepted a written mandate from a manufacturer outside Switzerland to act on the manufacturer's behalf for specified regulatory tasks.

    ELLECOM SWISS AG provides Swiss Authorised Representative services for medical device and IVD manufacturers, supporting access to the Swiss market under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO).

  • As CH-REP, ELLECOM SWISS AG provides the required regulatory representation between the foreign manufacturer and the Swiss authorities.

    Our activities include review of applicable Swiss labeling requirements, regulatory documentation support, economic-operator and device registration coordination, maintenance of required documentation, communication with Swissmedic, and support with applicable vigilance and incident-related obligations.

    Swissmedic requires the authorised representative's name and address to be appropriately identified. The CH-REP symbol may be used together with the name and address of the Swiss Authorised Representative.

    ELLECOM SWISS AG also supports manufacturers with the regulatory differences that need to be considered when placing devices on both the EU and Swiss markets.

  • Regulatory Representation for Access to the Indian Market

    India regulates medical devices and IVDs under the Medical Devices Rules, 2017, administered by the Central Drugs Standard Control Organisation (CDSCO).

    For imported medical devices, an overseas manufacturer may appoint an Authorised Agent in India through a Power of Attorney to undertake the applicable import-licensing activities.

    CDSCO defines an Authorised Agent as a person, firm, or organisation appointed by an overseas manufacturer through a Power of Attorney to undertake the import of medical devices in India.

  • Through its Indian regulatory presence, ELLECOM supports overseas medical device and IVD manufacturers with the regulatory activities required for market access in India.

    Depending on the product and applicable regulatory pathway, activities may include assessment of the device classification, preparation and coordination of regulatory documentation, support with CDSCO applications, import-licence activities, communication with the regulatory authorities, and management of applicable post-approval regulatory requirements.

    Under the Medical Devices Rules, the authorised agent acts as the official representative for obtaining the applicable import licence and submits the necessary documentation for the import-licence application.

    For applicable medical devices, the application for an import licence is made in Form MD-14, with the import licence granted in Form MD-15.

Do you have a specific question about Authorised Representative?

Whether it’s about EU or Swiss Authorised Representative, regulatory responsibilities, manufacturer and device registration, or ongoing compliance, our team is here to help.

Contact us to discuss your Authorised Representative requirements and market access needs.