A UK MHRA Certificate of Free Sale (CFS) for antimicrobial susceptibility tests identifies registered diagnostic products selected for export documentation. Its schedule connects the listed tests to the manufacturer’s antimicrobial combinations, testing formats, intended applications and conformity records.
The issued certificate can then be prepared for overseas use through verification, professional certification, an apostille and any required embassy legalisation.
Product category and MHRA registration: Antimicrobial Susceptibility Tests
Antimicrobial susceptibility tests intended to examine microorganisms isolated from human clinical specimens are IVD medical devices. Product formats can include discs, gradient strips or test panels, depending on the manufacturer’s system. The intended organism groups, antimicrobial agents, testing method and reported output belong to each product description. Different formats do not necessarily provide the same type of result.
The MHRA’s Device Online Registration System, or DORS, holds manufacturer, device and product records. Registration includes the relevant conformity information, such as CE or UKCA documentation, together with the details identifying the products. For manufacturers based outside the UK, a UK Responsible Person represents the manufacturer for the Great Britain registration process.
The MHRA’s medical device registration guidance explains the registration framework. The April 2026 reference guide describes how these records are entered and maintained in the online system.
For Great Britain, the manufacturer’s records sit within the UK medical device framework. A CFS order is submitted by an eligible UK-based manufacturer or UK Responsible Person, using registered products and the relevant CE or UKCA conformity evidence.
Documents and product information
The registration process brings together information about the manufacturer, the product and its conformity documentation. The main records include:
- Manufacturer details: the legal manufacturer’s name, registered address and contact information.
- UK Responsible Person documentation: representative details and the designation agreement, where applicable.
- Product details: test name, catalogue reference, legal manufacturer, format, antimicrobial identities and concentrations or ranges where relevant. Labels, instructions, conformity documents and technical records describe the intended organisms, performance characteristics, reading method and supported equipment. Storage, stability, expiry and quality control information relate to the supplied test presentation. Instrument compatibility is identified where the test uses a dedicated platform.
- Registration identifiers: the GMDN code and term, with Basic UDI-DI and UDI-DI where applicable.
- Conformity documentation: the Declaration of Conformity and applicable conformity assessment certificates, including their references, validity and product schedules.
- Supporting product records: labels, instructions for use and the technical and performance documentation held by the manufacturer.
The online registration links the relevant conformity documents to the device record and identifies the individual products beneath it. The wider technical documentation supports the manufacturer’s compliance records; it is not a separate standard upload package for each CFS order.
From MHRA registration to an electronic CFS
- Accepted registration establishes the manufacturer, device and individual product records in DORS. Current conformity documents are linked to the relevant entries.
- The applicant selects the products marked CFS Ready and reviews the certificate and schedule preview. Model names and catalogue references come from the registered product data.
- After the order is submitted and paid for, the MHRA issues an electronically signed PDF. The complete certificate and every schedule page form the document set for subsequent verification and legalisation.
IVDs registered for performance evaluation cannot be included in CFS orders.
The MHRA CFS Reference Guide describes these stages. The published CFS service information gives an issuance aim of ten working days, with longer processing possible during busy periods.
Product coverage in the CFS schedule
A susceptibility testing range can contain several panels, agent combinations and catalogue presentations. Panel maps or product specifications connect the supplied reference to the registered description. Readers, automated instruments, software and separately marketed controls may have their own identities even when used with the same test range. The CFS schedule identifies the selected registered entries rather than every component of a laboratory workflow. Complete schedule pages and product descriptions explain which discs, strips or panels appear in the certificate and which associated products are separately documented.
Direct verification of the CFS with the MHRA
For an overseas submission, the authenticity of the issued certificate is an important part of document preparation. Ginkgo Advisory can arrange for a solicitor to seek direct confirmation of the CFS with the MHRA and review the certificate together with its schedule.
Solicitor certification and express UK FCDO apostille
Where the solicitor-certified route is accepted for the intended submission, Ginkgo Advisory can arrange solicitor certification followed by a UK FCDO paper apostille. The certification format is matched to the receiving authority’s requirements. MHRA’s published guidance describes a notarial route, and notarisation is arranged where that route is required.
Our express UK FCDO apostille service normally takes two working days once verification and the required certification are complete and the document is accepted for submission. The apostille stage has its own timetable, separate from MHRA certificate issuance, verification responses, any embassy processing and delivery. Further FCDO checks can affect completion.
Embassy legalisation for Egypt, the UAE, Kuwait and Qatar
Ginkgo Advisory can arrange embassy legalisation where required, bringing the verification, certification, apostille and relevant embassy submission into one coordinated service. The destination and intended use determine the required document format and any additional stages.
Preparing an issued MHRA CFS for overseas use
For a quotation, the starting documents are the MHRA-issued electronic PDF and all accompanying schedule pages. The issuance email, destination country, receiving authority’s instructions and required completion date help establish the appropriate preparation and delivery arrangements.
Contact Ginkgo Advisory with the issued CFS for a quotation covering direct MHRA verification, solicitor certification where accepted, express FCDO apostille and any required embassy legalisation.
Product questions
Does a panel CFS include other antimicrobial combinations for the same instrument?
Each panel’s description identifies its antimicrobial combination and intended application. Compatibility with the same instrument does not establish identical product coverage. The registered entries selected for the order and the issued schedule identify which panel references are listed and how any instrument is represented.