CE recognition and an MHRA Certificate of Free Sale Apostille serve different purposes. The government\’s decision to continue recognising qualifying CE-marked medical devices in Great Britain does not remove the document requirements of an overseas regulator. If an importer requests an MHRA Certificate of Free Sale (CFS), the certificate may still need authenticity verification, appropriate professional certification, an FCDO Apostille and further embassy attestation.
Ginkgo Advisory helps manufacturers, UK Responsible Persons and exporters prepare MHRA certificates for overseas use. This guide connects the CE-recognition announcement with the practical steps needed to prepare a CFS for its receiving authority.
By Ginkgo Advisory Team · Request a review of your CFS and destination requirements
What does indefinite CE recognition mean for medical devices?
On 21 October 2026, the government confirmed its policy of indefinite recognition of CE-marked medical devices in Great Britain. UKCA remains a domestic route. The detailed consultation outcome distinguishes indefinite recognition of devices compliant with EU MDR or EU IVDR from alignment of transitional arrangements for legacy EU MDD devices.
The outcome describes intended legislative changes. Do not treat the press release alone as proof that every implementation provision is already in force. Check the applicable legislation, current MHRA guidance and your device\’s conformity documentation before making a market-access decision. The reform concerns Great Britain: England, Wales and Scotland. Northern Ireland has a separate framework.
Recognition does not mean that registration, an applicable UK Responsible Person appointment or post-market surveillance responsibilities disappear. Nor does it turn an expiring conformity certificate into a permanent certificate. The announcement supports regulatory planning; it does not replace the checks needed for a particular product.
CE marking, MHRA CFS, Apostille and attestation: what is the difference?
| Item | Main question | What it does not establish |
|---|---|---|
| CE conformity documentation | Which EU conformity requirements and device scope does the evidence cover? | Acceptance of every export document by a foreign authority. |
| MHRA Certificate of Free Sale | What does MHRA\’s certificate state about the listed devices and market? | Government endorsement, UK manufacture or approval in every destination. |
| FCDO Apostille | Can the relevant signature, seal or stamp be authenticated? | Medical-device approval or validation of the certificate\’s substantive claims. |
| Embassy or consular attestation | Has the required destination-specific authentication step been completed? | Automatic import permission or regulatory registration. |
For example, an importer may still require a legalised CFS even where the device\’s CE documentation supports access to Great Britain. Confirming the document requirement before ordering certification avoids preparing a perfectly authenticated certificate that answers the wrong regulatory question.
Who can obtain an MHRA Certificate of Free Sale?
The MHRA\’s CFS guidance covers eligible registered medical devices and IVDs. Applicants must fall within the permitted categories: a UK-based manufacturer, UK Responsible Person or Northern Ireland-based authorised representative. IVDs intended for performance evaluation cannot be included.
Before placing an order, check the certificate preview, market wording, device list and recipient\’s instructions. A CE mark alone does not settle every CFS eligibility or wording question. Where the device is manufactured outside the UK, specifically ask whether the recipient accepts an MHRA CFS or requires evidence from the country of manufacture. Certification cannot change the manufacturer\’s country of origin.
How Ginkgo prepares an MHRA CFS for Apostille and attestation
1. Review the original certificate and receiving requirements
Send the original electronic file with all product schedules. We review the certificate reference, named organisations, product details, completeness and requested use. If a model or manufacturer name is wrong, resolve the underlying certificate with the issuer or applicant before legalisation. We do not alter MHRA\’s certificate to fit a submission.
2. Verify authenticity and identify the required professional act
Source verification and certification of a copy are different checks. A statement that a printout matches a PDF does not, by itself, confirm that MHRA issued it. Our review identifies the evidence and any source confirmation needed, and the professional statement must accurately reflect the work completed.
MHRA issues electronically signed PDFs and states that the FCDO will not authenticate those PDFs directly. Its published route describes a notary checking the certificate with MHRA and notarising it where required. Ginkgo offers solicitor-led review and suitable solicitor certification where accepted, and can coordinate required notarial work. Solicitor certification must not be presented as a substitute for a specifically required notarial act.
3. Arrange the appropriate FCDO Apostille
We assess the document against the FCDO legalisation requirements and the recipient\’s instructions. Paper and electronic routes are not interchangeable for every submission. An electronically issued MHRA certificate does not automatically mean an e-Apostille will be accepted by the destination or a subsequent embassy.
Our eligible express option can take two working days for the Apostille stage after preparation is complete, subject to acceptance and availability. MHRA issuance, verification, notarial work, embassy processing, translation and delivery require separate time. See our UK Apostille service.
4. Coordinate further attestation and return delivery
Some submissions require an Apostille only; others need additional embassy, consular or commercial-document formalities. We review the destination and intended use before proposing the route. Ask the recipient whether the certificate, schedules and professional certification need translation, and confirm the delivery address and deadline at the outset.
Our MHRA Certificate of Free Sale verification, Apostille and attestation service explains the document support available.
What should manufacturers and exporters send us?
- The complete original MHRA CFS PDF and every product schedule or annex.
- The destination country, receiving authority, importer and intended use.
- Written instructions specifying certification, notarisation, Apostille, attestation and translation.
- Confirmation that the certificate\’s market and origin wording are acceptable.
- The submission deadline, certificate expiry and preferred return-delivery address.
- Any previous rejection notice, so we can assess the actual reason.
Keep a consistent document list across the CFS, regulatory dossier and legalisation request. Check model numbers, company names and the pages that must remain attached. A change to the product schedule after certification may require the document pack to be prepared again.
Frequently asked questions
Does indefinite CE recognition remove the need for a CFS?
No. Recognition concerns the Great Britain market-access framework. The foreign recipient decides whether it requires a CFS and what legalisation it needs.
Is every legacy CE-marked device covered indefinitely?
Do not assume so. The response separates EU MDR and IVDR recognition from legacy MDD transition arrangements. Check the device\’s applicable route and implementation rules.
Does the announcement make an existing CFS valid indefinitely?
No. Check the expiry printed on the certificate and any recency requirement imposed by the recipient. An Apostille does not renew the underlying CFS.
Can the MHRA PDF receive an Apostille without preparation?
MHRA says its PDFs cannot be authenticated directly by the FCDO. The required verification and professional preparation must be addressed first.
Does an Apostille guarantee overseas medical-device registration?
No. Document authentication and product approval are separate. The receiving regulator assesses the product and the supporting dossier.
Can the entire process finish in two working days?
The express estimate applies only to the eligible Apostille stage after preparation. We provide a case-specific timetable for the complete process.
Can an overseas manufacturer contact Ginkgo directly?
Yes. We can review your existing CFS and intended legalisation route remotely. Issuance of a new certificate remains subject to MHRA\’s applicant and device requirements.
Request an MHRA CFS document review
Ginkgo Advisory, based in Richmond, London, coordinates document preparation for overseas use. Send your complete certificate, written recipient requirements and deadline. We will explain the verification, certification, Apostille and any further attestation needed for the proposed submission.
Email: apostille@ginkgoadvisory.com
Contact Ginkgo Advisory for a document review and quotation