Representative for the Sponsor of Clinical Investigations

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In the European Union (EU), the United Kingdom (UK), Switzerland, or the United States (US), a representative who acts on behalf of a sponsor of a clinical study must be designated if the sponsor does not have an established presence in the country or region.

While detailed responsibilities vary, ensuring regulatory compliance, communication with regulators and, as required, submission of study-related documents are part of the representative’s duties.

In the EU, a EU Legal Representative must be designated, ensuring compliance with the requirements set out under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), including any additional national requirements of the countries in which the study is conducted.

Article 62.2 MDR / Article 58.4 IVDR

2. Where the sponsor of a clinical investigation/performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation. Any communication with that legal representative shall be deemed to be a communication with the sponsor.

In the UK, if a representative — often called a UK Responsible Person (UKRP) or UK Legal Representative — is required for companies without presence in the UK, then this entity is responsible for the compliance with the UK Regulations, including notifying the MHRA.

The Medical Devices Regulations 2002

16.—(1) Subject to paragraph (2), no person shall supply a relevant device (if that supply is also a making available of the device) for the purposes of a clinical investigation in Great Britain unless, before he does so, the manufacturer of the device or their UK responsible person has given at least 60 days prior notice in writing to the Secretary of State of the intended investigation, …

In Switzerland, an agent must be designated, ensuring compliance with the requirements set out under the Ordinance on Clinical Trials of Medical Devices

Article 4.3 ClinO-MD

3 If the sponsor is not domiciled in Switzerland and does not have a place of business there, it must designate an agent that is domiciled or has a place of business in Switzerland as an address for correspondence. This agent must ensure compliance with the sponsor’s obligations.

The US sponsor of a clinical study acts on behalf of the foreign manufacturer and is responsible for the regulatory aspects of the study.

The responsibilities of a US Sponsor include liaising with the U.S. Food and Drug Administration (FDA), submitting Investigational Device Exemptions (IDEs), submitting IDE reports, and interacting with Institutional Review Boards (IRBs). Additionally, US Sponsors may interact with investigators and conduct study monitoring.

21 CFR 812 (“IDE CFR”)

Any manufacturer outside of the US who wishes to import an investigational device into the US for the purpose of conducting a clinical investigation subject to an IDE is required to designate a U.S. agent who acts as the sponsor of such clinical study (“US Sponsor“) to fulfil all responsibilities of a sponsor as set out in the IDE CFR.

Let us be your solution!

At MDSS, we support your compliance with clinical study requirements through our comprehensive services:

Representation: We will serve as your EU Legal Representative, UK Legal Representative, or US Sponsor.
Cooperation and point of contact with regulatory authorities: We will be the primary contact for all communication with regulatory agencies and ethics committees/IRBs.
Documentation: We will record and provide all interactions with regulatory agencies, ethics committees/IRBs, and deliver them to you. We will verify submissions to ensure all necessary sections are included.