Medical devices · Cosmetics
Your regulatory path to the United Kingdom.
Medical devices are regulated by the MHRA and cosmetics by the UK Cosmetics Regulation. We plan your route and, through a qualified partner, provide your UK Responsible Person.
Medical devices · Cosmetics · ISO 9001 certified in Brazil · Service in PT · EN · DE
WHERE YOU ARE COMING FROM
Two starting points, one market
First time in the UK
You are outside the United Kingdom and want to sell your device or cosmetic in Great Britain.
- Your route defined: CE marking recognised in GB, or UKCA
- MHRA device registration before placing on the market
- A UK Responsible Person, through a qualified partner
Already on the EU market
Your product is CE-marked or notified in the EU and the UK is your next step.
- CE-marked devices are accepted in Great Britain for a transition period
- Cosmetics: CPSR and SCPN notification for Great Britain
- Northern Ireland follows EU rules
What are you bringing to the UK?
Each product follows its own UK rules. Pick yours for the full path.
Medical Devices
Equipment, implants and software, from route choice to MHRA registration.
SERVICES IN THE UNITED KINGDOM
Everything we do for the UK market
Route, documentation and local representation for Great Britain.
Strategy: CE or UKCA
Which marking to use in Great Britain, and until when.
MHRA device registration
Registration before placing devices on the GB market.
Quality system and technical file
ISO 13485 and documentation for UK requirements.
Biological and clinical evaluation
ISO 10993 and clinical evidence for your device.
CPSR for Great Britain
Safety report signed by a qualified safety assessor.
SCPN notification and labelling
Notification in the UK portal and label review.
UK Responsible Person
Through a qualified partner, for devices and cosmetics.
Ongoing support
Monthly support for changes, renewals and UK updates.
Why Sobel
Regulation as a business decision, not a checklist.
Four disciplines work on every project, in the same team, from the first decision to post-market.
Strategy
Classification and market sequence decided first. The right class from day one avoids rework.
Science in house
Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.
Regulatory, five markets
ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.
Technology
A dedicated technology team builds the workflows that keep every project traceable and on time.
“We know how auditors think, because we’ve been one of them.”
Maik Endler
Founder & CEO
- Mechanical engineer, trained in Germany
- Former BSI auditor (Notified Body)
- Industry experience at Sirona (now Dentsply Sirona)
FAQ · UNITED KINGDOM
What companies ask before entering the UK
Short answers for medical devices and cosmetics in Great Britain.
Ask your question →Who regulates medical devices and cosmetics in the UK?
Medical devices are regulated by the MHRA (Medicines and Healthcare products Regulatory Agency). Cosmetics in Great Britain follow the UK version of the Cosmetics Regulation, with notification through the government SCPN service. Northern Ireland follows EU rules.
Is my CE marking accepted in Great Britain?
For now, yes. Devices CE-marked under the EU MDR can be placed on the GB market until 30 June 2030. Devices under the former directives are accepted until their certificate expires or 30 June 2028, whichever comes first.
Do I need a UK Responsible Person?
Yes. Device manufacturers based outside the UK must appoint a single UK Responsible Person, and every device must be registered with the MHRA before it is placed on the GB market. Cosmetics also need a Responsible Person established in the UK. Sobel provides this service through a qualified partner.
What does a cosmetic need before going on sale in Great Britain?
A safety assessment in the form of a Cosmetic Product Safety Report signed by a qualified safety assessor, a product information file, notification through SCPN before the product is placed on the market, and compliant labels. See our CPSR for the EU and UK.
