Ensure full compliance with EU and UK cosmetic regulations with a professionally compiled Product Information File (PIF). Patient Guard supports manufacturers, brand owners, and importers by preparing, reviewing, and maintaining PIFs to meet regulatory requirements and facilitate smooth market access.
Cosmetic manufacturers must prepare and maintain a Product Information File (PIF) to demonstrate compliance with EU Cosmetic Regulation (EC) No 1223/2009 and UK cosmetic regulations.
A Product Information File is a mandatory requirement for placing cosmetic products on the market in the European Union and the United Kingdom. It must contain detailed information about the product, including safety data, formulation, manufacturing processes, and supporting documentation.
Patient Guard acts as your cosmetic regulatory consultancy, supporting manufacturers with PIF preparation, documentation review, and regulatory compliance.
Without a compliant PIF, cosmetic products cannot be legally placed on the market or registered on the Cosmetic Product Notification Portal (CPNP) or the Submit Cosmetic Product Notifications (SCPN) system.
We provide expert PIF services for cosmetic manufacturers worldwide, ensuring your documentation is complete, compliant, and audit-ready.
Speak to our regulatory experts today to ensure your cosmetic products meet EU and UK regulatory requirements.
This page explains Patient Guard’s Product Information File (PIF) services for cosmetic manufacturers. If you're looking for a broader introduction to cosmetic compliance, including Regulation (EC) No. 1223/2009, Responsible Person requirements, Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), CPNP notification and labelling obligations, read our Cosmetics Regulation for Beginners Guide.
Our regulatory specialists ensure your Product Information Files are flawlessly optimized for both UK and EU cosmetic regulations seamlessly.
We handle everything from initial formula screening and documentation collection to compiling and updating the final structural file framework.
We smoothly weave your mandatory Cosmetic Product Safety Report data directly into the PIF, ensuring a perfectly audit-ready setup.
We support your brand through future formulations, manufacturing variations, and ongoing regulatory changes over the device's market span.
Since 2017, hundreds of global brands have trusted our professional services firm to navigate complex product safety frameworks safely.
We avoid over-complicated administration, organizing your technical compliance dossiers into clean, accessible formats for authorities.
Verifying the inclusion of a rigorous, fully signed Cosmetic Product Safety Report to establish product composition safety.
Compiling clear product descriptions, identification metrics, exact structural formulas, and physical/chemical raw material profiles.
Documenting your manufacturing methods to demonstrate complete compliance with Good Manufacturing Practices (ISO 22716 standards).
Reviewing product text labels, packaging compliance, warning symbols, and structuring supporting data for all cosmetic claims.
Reviewing development trails to compile precise documentation confirming complete compliance with strict animal testing prohibitions.
Structuring the file framework to ensure it is readily accessible to UK and EU competent authorities while managing lifecycle updates.
Under EU and UK cosmetic regulations:
We assess your product formulation, ingredients, and documentation
We gather all required safety, manufacturing, and supporting data
We compile your Product Information File in line with regulatory requirements
We verify that your documentation meets EU and UK regulations
We deliver your PIF and provide ongoing support for updates and compliance
We support a wide range of cosmetic products, including:
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Support your market access with expertly prepared, fully compliant Cosmetic Product Information Files (PIFs). Pricing starts at £500 per PIF, with preferential rates for multiple products.
Provide formulation, ingredient data, packaging, and supporting documentation
Our experts compile and verify your Product Information File to ensure full compliance
Receive your completed PIF, with optional updates and support for future regulatory needs.
Efficient delivery: PIFs are typically completed within 5–10 working days, with timelines tailored to product complexity and data readiness.
A PIF is a regulatory document that contains all the information required to demonstrate that a cosmetic product is safe and compliant with EU and UK cosmetic regulations.
Yes, a PIF is a legal requirement for all cosmetic products placed on the EU or UK market.
A PIF includes the Cosmetic Product Safety Report (CPSR), product description, manufacturing information, labelling details, and supporting data.
A PIF must be retained for at least 10 years after the last batch of the product has been placed on the market.
Click on the links below to discover more:
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Preparing to sell digital health technology to the NHS requires more than completing DTAC. This guide explains how manufacturers can build a procurement-ready position by aligning regulatory compliance, clinical safety, data protection, cybersecurity, interoperability, accessibility and commercial evidence for NHS market access.
For digital health manufacturers preparing to enter the NHS, clinical safety can be one of the most important—and sometimes misunderstood—parts of DTAC.
It is not enough to demonstrate that your software works.
Manufacturers need to consider what could happen if the technology fails, produces incorrect information, presents information incorrectly, contributes to a workflow error or is used in circumstances that could expose patients to harm.
This is where clinical risk management and DCB0129 become particularly important.
NHS England identifies DCB0129 as the clinical risk management standard for manufacturers of health IT systems. Its counterpart, DCB0160, applies to health organisations deploying and using health IT systems. NHS England states that compliance with these standards is required under the Health and Social Care Act 2012.
For manufacturers working towards NHS DTAC readiness, understanding the distinction—and having the right clinical safety evidence—is essential.
If your digital health technology is heading towards the NHS, understanding the Digital Technology Assessment Criteria (DTAC) should be part of your market-access planning.
But one of the biggest mistakes manufacturers can make is treating DTAC as simply another questionnaire to complete.
The questions are only part of the process.
Behind your answers needs to be evidence showing that your technology and organisation have appropriate arrangements for clinical safety, data protection, technical security, interoperability, and usability and accessibility.
These five areas form the core of NHS DTAC. NHS England describes DTAC as national baseline criteria for digital health technologies entering NHS and social care.
For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
It is:
“Can we demonstrate that our product meets the requirements?”
This guide looks at each of the five DTAC areas, the types of evidence manufacturers should consider and some of the common gaps that can delay NHS readiness.
A complete guide to NHS DTAC compliance for digital health manufacturers, covering the five DTAC assessment areas, required evidence, clinical safety, data protection, technical security, interoperability and usability, and how to prepare your digital health technology for NHS procurement.
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.
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