
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Patient Guard provides UK Responsible Person (UKRP) services for cosmetic products, supporting compliance with UK cosmetic regulations. We act as your UK Responsible Person, ensuring your products can be legally placed on the UK market.
Cosmetic manufacturers based outside the United Kingdom must appoint a UK Responsible Person (UKRP) to legally place their products on the Great Britain market under UK cosmetic regulations derived from Regulation (EC) No 1223/2009.
A UK Responsible Person acts as your legal presence within the UK, ensuring compliance with regulatory requirements, including SCPN registration, Product Information File (PIF) maintenance, and post-market surveillance obligations.
Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with UK cosmetic compliance, SCPN registration, and market access.
Without a UK-based Responsible Person, manufacturers cannot register their products on the Submit Cosmetic Product Notifications (SCPN) portal or legally sell cosmetics in Great Britain.
We provide expert UK Responsible Person services for cosmetic manufacturers worldwide, supporting SCPN registration, PIF review, Cosmetic Product Safety Report (CPSR) verification, and ongoing regulatory compliance.
Speak to our regulatory experts today to ensure your cosmetic products meet UK regulatory requirements and are ready for market access.
We have supported cosmetic manufacturers with UK regulatory compliance for over 9 years.
We support start-ups, SMEs and global brands with cosmetic compliance and UK market access.
Fast, reliable support when dealing with UK authorities and regulatory requirements.
Clear annual pricing with no hidden fees.
We act as your official UK Responsible Person under a formal agreement.
We review your documentation to ensure compliance with UK cosmetics regulation, including labelling and CPSR.
We support product registration within the OPSS SCPN system.
We verify that your cosmetic products meet UK regulatory requirements before market placement.
We act as your point of contact with the Office for Product Safety and Standards (OPSS).
We support incident reporting and ongoing compliance obligations.
Under UK cosmetic regulations:
We assess your product and regulatory requirements
We review PIF, CPSR and supporting documentation
Formal appointment via mandate agreement
Submission and verification of product data
Support with regulatory updates and vigilance
We support a wide range of cosmetic products, including:
Per Year
Ensure your smooth entry into the UK cosmetics market with a UKRP you can trust
We receive your PIF including labelling and CPSR.
We review the documents, typically half a day per PIF
We then register the products on the SCPN database, 1 hour per PIF
Time lines can be as little as 1 business day for single product review and registration, from the day we receive the files from you. This is dependent on all of the information being correct and no corrections needed to the PIF, labelling or CPSR.
A UK Responsible Person ensures compliance with UK cosmetic regulations, registers products on the SCPN system, maintains product information files, and acts as the manufacturer’s legal representative within Great Britain.
Yes, all manufacturers based outside the UK (Great Britain: England, Scotland, and Wales) are legally required to appoint a single UK Responsible Person (UKRP) to place Cosmetic Products on the UK market. The UKRP must be established in the UK and assumes legal accountability for regulatory compliance, including registration with OPSS.
Yes, a Cosmetic Product manufacturer can change their UK Responsible Person (UKRP) at any time. The process involves terminating the existing agreement, appointing a new UKRP via a new letter of designation, updating product information file information, labelling, and registering the change on the SCPN system. Only one UKRP can be appointed at a time.
Patient Guard charges an annual fee, this covers as many Cosmetic Products as the manufacturer wishes to place on the UK market.
If all of the documentation that is required is available and correct, the process should take as little as 2 business days, for a single product that needs to be registered. However, this is dependent on how many cosmetic products need to be registered and how much documentation needs to be assessed.
Click on the links below to discover more:

Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.

Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.

Regulatory approval is not the end of scrutiny, it is the beginning of structured data collection.

If you are implementing a medical device QMS, preparing for certification, or recovering from audit findings, understanding ISO 13485:2016 requirements is non-negotiable.

2026 represents a significant milestone for the amended IVDR transitional provisions framework.

If you sell cosmetics in the UK or EU, you are legally required to maintain a Cosmetics Product Information File – even if you’re a tiny indie brand mixing batches between client emails.
Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
UK Office
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Thank you! The checklist is now ready to download.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office