
Clinical Evaluation Report: EU MDR Requirements
Clinical evidence is central to demonstrating the safety and performance of medical devices in the European Union.
Our EU Responsible Person (EURP) services support cosmetic brands in achieving compliance with EU regulations. Patient Guard acts as your EU Responsible Person, ensuring safe and compliant access to the European market.
Cosmetic product manufacturers based outside the European Union must appoint an EU Responsible Person (EURP) to legally place products on the EU market under the Cosmetic Products Regulation (EC) No 1223/2009.
An EU Responsible Person acts as your legal presence within the EU, ensuring compliance with regulatory requirements, including CPNP registration, product safety documentation, and post-market obligations.
Patient Guard acts as your EU Responsible Person for Cosmetics, ensuring full compliance with EU cosmetic regulations and smooth access to the European market.
Without an EU-based responsible person, manufacturers cannot register products on the Cosmetic Product Notification Portal (CPNP) or legally sell cosmetics within the European Union.
Patient Guard provides expert EU Responsible Person services for cosmetic manufacturers worldwide. We support CPNP registration, Product Information File (PIF) review, Cosmetic Product Safety Report (CPSR) verification, and ongoing regulatory compliance.
Whether launching a new product or transferring from an existing EURP, we ensure a smooth and compliant route to EU 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 EU market access.
Fast, reliable support when dealing with EU authorities and regulatory requirements.
Clear annual pricing with no hidden fees.
We act as your official EU Responsible Person under a formal mandate agreement.
We review your documentation to ensure compliance with EU cosmetics regulation, including labelling and CPSR.
We support submission and verification of product information within the Cosmetic Product Notification Portal (CPNP).
We verify that your cosmetic products meet EU regulatory requirements before market placement.
We act as your point of contact for regulatory authorities within the EU.
We support incident reporting and ongoing compliance obligations.
Under EU Regulation (EC) No 1223/2009, an EU Responsible Person is responsible for ensuring that cosmetic products comply with regulatory requirements, including:
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 EU cosmetics market with an EURP 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 CPNP 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.
An EU Responsible Person (EURP) acts as the mandatory legal representative for non-EU Cosmetic Product manufacturers placing products on the European Union market. They register cosmetics with the CPNP registration system, hold product information files, and handle post-market surveillance.
Yes, all manufacturers based outside the EU are legally required to appoint a single EU Responsible Person (EURP) to place Cosmetic Products on the EU market. The EURP must be established in the EU and assumes legal accountability for regulatory compliance, including registration with CPNP.
Yes, a Cosmetic Product manufacturer can change their EU Responsible Person (EURP) at any time. The process involves terminating the existing agreement, appointing a new EURP via a new mandate, updating product information file information, labelling, and registering the change on the CPNP system. Only one EURP 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 EU 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