The rule that changes everything for UK device companies
Under 21 CFR 812.18(a), a company located outside the United States cannot itself sponsor an FDA Investigational Device Exemption study. The regulation states: 'If a sponsor is not located in the United States, the sponsor shall designate a United States agent to serve as sponsor.' That designated US person carries every obligation Part 812 places on a sponsor, including IDE application preparation, investigator oversight, recordkeeping, adverse event reporting, and all correspondence with FDA. This is not a formality. It is a hard structural requirement that determines who stands before FDA as the responsible party for the entire study.
Why Brexit created a two-role problem
A UK medical device company running a clinical study simultaneously in the United Kingdom and in the United States now needs two separate roles filled, one in each jurisdiction. The UK role addresses post-Brexit domestic requirements under MHRA's framework, while the US role addresses the entirely separate obligations of a Part 812 sponsor operating under FDA jurisdiction. Neither role satisfies the other, and conflating them is a compliance risk that can delay or derail both programs.
The UK post-Brexit Responsible Person requirement
Since the United Kingdom left the European Union, MHRA has introduced its own requirements for medical devices placed on the Great Britain market. Among those requirements is the concept of a UK Responsible Person, which MHRA uses to describe the entity or individual based in the United Kingdom who registers the device with MHRA and takes on defined accountability for regulatory compliance within Great Britain. MHRA uses the term 'UK Responsible Person' consistently in its own guidance, and that vocabulary reflects a role tied to market access and product registration within the UK regulatory system.
This role is entirely distinct from what FDA requires under 21 CFR 812. The UK Responsible Person function concerns product registration and in-country accountability under MHRA's post-Brexit framework. The US IDE sponsor function concerns the design, conduct, and oversight of a clinical investigation submitted to and reviewed by FDA. A UK company needs both, and they cannot be served by the same entity unless that entity is physically present and legally authorized in both jurisdictions.
What 21 CFR Part 812 actually requires of the US sponsor
Part 812 is the comprehensive FDA regulation governing investigational device studies in the United States. The US sponsor is responsible for preparing and submitting the IDE application, selecting and monitoring qualified investigators, reviewing and approving investigator agreements, maintaining required records, submitting progress and safety reports, and responding to any FDA inquiries or requests for additional information. For nonsignificant risk device studies that qualify for the abbreviated IDE requirements under 812.2(b), sponsor obligations still apply even without a full IDE submission to FDA. The burden on the US sponsor is substantive across the full lifecycle of the study, from pre-submission through study closure.
For non US companies, including those based in the United Kingdom, Canada, the European Union, or anywhere else outside the United States, the designation of a US sponsor or sponsor-agent is not optional. FDA will direct all communications, holds, and enforcement actions to the US-based sponsor of record. That person or entity must be reachable, responsive, and fully conversant with Part 812 at all times during the study.
How ADB serves non-US sponsors from the United States
ADB Consulting and CRO Inc. is a US regulatory consulting firm. We serve non-US device sponsors from our operations in the United States. We do not claim UK representation, in-country UK presence, or the ability to serve as a UK Responsible Person. Our scope is US regulatory affairs, and that scope is intentional. When a UK company comes to ADB, we assess their IDE strategy, review their study documentation, and prepare their FDA submissions as the designated US-based sponsor entity. We do not advise on MHRA registration requirements, and we refer clients to appropriately qualified UK counsel for that work.
Clients interested in our broader international services can learn more at adbccro.com/international, with UK-specific context available at adbccro.com/international/united-kingdom. Canadian device companies considering a US IDE study will also find relevant background at adbccro.com/canadian-device-manufacturers-us-ide-study.
ADB Consulting and CRO Inc. serves as US Sponsor of Record for non-US medical device companies conducting FDA-regulated investigational studies in the United States.
Book a free discovery call with ADB
If your company is preparing to bring a device study into the United States and you need to assess your IDE readiness and sponsor designation structure, the ADB regulatory team is ready to help. Visit adbccro.com to book a free discovery call and review your path forward with a team that works exclusively in US medical device regulatory affairs.
Reviewed November 14, 2026 by ADB's regulatory team.
Frequently asked questions
Can a UK company serve as its own FDA IDE sponsor?
No. Under 21 CFR 812.18(a), a company located outside the United States must designate a US person or entity to act as sponsor and carry all Part 812 obligations. The UK company remains the originating party for the technology, but FDA holds the designated US sponsor accountable for the study at every stage. A UK company that attempts to submit an IDE without a proper US sponsor designation will find the application procedurally deficient from the outset.
Is the UK Responsible Person the same as the US IDE sponsor?
No. These are two separate regulatory roles in two separate jurisdictions. The UK Responsible Person is a concept within MHRA's post-Brexit framework for device market access in Great Britain. The US IDE sponsor is a role defined by FDA under 21 CFR Part 812 for companies conducting investigational studies in the United States. A UK company running studies in both countries must address both requirements independently, and meeting one does not satisfy the other in any respect.
What does ADB actually do as US Sponsor of Record?
ADB assesses the IDE strategy, reviews study protocols and risk documentation, prepares and submits the IDE application to FDA, communicates with FDA on the sponsor's behalf, reviews investigator agreements and monitoring plans, and prepares required safety and progress reports throughout the study. All of this work is conducted from ADB's US operations. We do not perform MHRA submissions, UK registration support, or any function requiring in-country UK presence or authority.
If this applies to your program, U.S. Market Entry for Non-U.S. Device Manufacturers walks through the process in detail.
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