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To sell medical devices in the United Kingdom, manufacturers must comply with demanding safety standards. They must ensure a high level of consumer protection and meet the requirements of the UK Medical Devices Regulations. These legislative acts are an adaptation of the Medical Devices Directive 93/42/EEC within the British legal system.
Manufacturers of medical devices compliant with the UK MDR may place their devices on the UK market after notifying the MHRA. Upon confirmation from the UK authorities, they can apply for a Certificate of Free Sales (CFS). A CFS enables them to place their devices on overseas markets by presenting proof that they fulfill the UK regulatory requirements.
In other words, with such Certificates many countries worldwide accept proof of conformity in the UK and EU as a presumption of conformity in their own countries.
How to apply for a FSC
A CFS is the UK equivalent of the EU Free Sales Certificate, which certifies a medical device’s full compliance with EU legislation. With a CFS, manufacturers prove the safety of their medical devices worldwide and, thus, enter third countries’ markets.
However, this does not apply in countries such as the European Union Member States, which rely on their statutory approval procedures.
Specifically, the actors that can apply for CFS are:
- UK-based manufacturer, UK Responsible Person (UK RP), or
- Northern Ireland-based Authorised Representative (AR)
MHRA (Medicines and Healthcare products Regulatory Agency) will issue a distinct CFS according to the location of the manufacturer, UK RP, or AR, as well as the mark of conformity.
Products eligible for export
The products eligible for export under CFS are medical devices (MD) or in-vitro diagnostics devices (except for IVDs for performance evaluation) that must bear the mandatory UKCA, CE, or CE UKNI marking (mark of conformity).
UKCA (UK Conformity Assessed), CE (European Conformity), or UKNI (UK Northern Ireland) marking demonstrates that medical devices bearing one of the mentioned markings meet all the conformity assessment processes and standards. This means that manufacturers can sell medical devices on specific markets:
- UKCA marked devices – can be freely sold in Great Britain (England, Wales, and Scotland)
- CE marked devices – can be freely sold in the UK and EEA
- CE UKNI-marked devices – can be freely sold in the UK
Are you a medical device manufacturer looking to expand your business globally?
Obelis UK is certified according to the international standards ISO 9001:2015 and ISO 13485:2016 for representative and consulting services.
Our regulatory affairs consultants are committed to deliver the most efficient compliance process and support manufacturers to safely place their products on the UK market.
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