A UK MHRA Certificate of Free Sale (CFS) for non-medicated PMMA bone cement supports overseas documentation for registered orthopaedic fixation products. Its schedule connects selected cement references to the manufacturer’s formulation descriptions, specifications 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: Bone Cement
Non-medicated polymethylmethacrylate, or PMMA, bone cements for the specified fixation of prosthetic implants are general medical devices. Commercial presentations typically include powder and liquid components that form the cement material. The manufacturer defines the intended orthopaedic application, supplied formulation and handling characteristics. This product description concerns formulations without an added medicinal substance.
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: cement name, catalogue reference, legal manufacturer, formulation, powder and liquid quantities, pack configuration and intended application. Labels, instructions, conformity documents and technical-file records describe composition, mechanical performance, setting characteristics and biological evaluation. Documentation also identifies the supplied sterility status, packaging, storage conditions and shelf life for the presentation.
- 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.
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 cement range can contain different quantities, formulation characteristics and packaging arrangements under a common brand. Individual references connect the matched powder-and-liquid presentation to its registered description and conformity scope. Mixing bowls, mixing systems, applicators and prosthetic implants may have separate product identities even when offered in the same supply package. The CFS schedule lists the selected cement entries rather than the entire orthopaedic equipment range. Complete schedule pages and contents descriptions allow recipients to match the certificate to the precise non-medicated cement product in their dossier.
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 bone cement CFS also cover its mixing and delivery equipment?
The manufacturer’s component description establishes the supplied cement presentation. Mixing or delivery devices marketed separately can have their own references and records. The selected registered entries and issued schedule identify which products are included in the certificate set.