A UK MHRA Certificate of Free Sale (CFS) for blood grouping reagents supports overseas documentation for registered immunohaematology products. The certificate schedule links the selected reagents to their specificities, methods, supplied presentations, manufacturer details and applicable 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: Blood Grouping Reagents
Blood grouping reagents intended for in vitro examination of human blood are IVD medical devices. The manufacturer defines the relevant blood group system, target antigen or other grouping application. Products can include reagents for ABO or RhD typing and reagent red cells for specified grouping procedures. Liquid, card or other formats have distinct intended methods and equipment requirements where applicable.
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: reagent name, catalogue reference, legal manufacturer, specificity, presentation, quantity and intended method. Labels, instructions, conformity documents and technical records describe specimen requirements, analytical performance and supported manual or instrument procedures. Reagent characteristics, storage conditions, stability and expiry are recorded for the supplied presentation. Compatibility information identifies any dedicated cards, readers or analytical platforms used with the product.
- 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 blood grouping range may include several specificities, reagent combinations and pack sizes under one commercial name. The registered descriptions and catalogue references distinguish each listed presentation. A card containing several reagents has its own documented composition, while separately marketed controls, instruments and other immunohaematology reagents may have separate product identities. The CFS schedule follows the entries selected for the certificate order. Complete schedule pages and product records explain which grouping reagents are represented without extending coverage to the manufacturer’s entire blood testing portfolio.
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 an ABO reagent CFS automatically cover the manufacturer’s RhD reagents?
ABO and RhD reagents have their own specificities and documented product identities. Both can be represented when their relevant registered entries are included in the order. The issued schedule establishes the actual coverage, supported by catalogue references and descriptions of the selected reagent presentations.