Our EU Responsible Person (EURP) services support PPE manufacturers and importers in achieving compliance with EU regulations. Patient Guard acts as your EU Responsible Person, ensuring safe and compliant access to the European market.
PPE manufacturers and importers placing products on the European Union market must ensure compliance with Regulation (EU) 2016/425 on Personal Protective Equipment.
An EU Responsible Person acts as your legal presence within the EU, ensuring compliance with regulatory requirements, including technical documentation, CE marking obligations, and post-market surveillance.
Patient Guard acts as your EU PPE regulatory consultancy, ensuring full compliance with EU PPE regulations and smooth access to the European market.
Where required, an EU-based Responsible Person ensures that PPE products meet all applicable EU requirements and that documentation is available to competent authorities upon request.
Patient Guard provides expert EU Responsible Person services for PPE manufacturers and importers worldwide. We support CE marking compliance, technical file verification, labelling requirements, and ongoing regulatory obligations.
Whether launching a new product or transferring from an existing representative, we ensure a smooth and compliant route to EU market access.
Under Regulation (EU) 2016/425, PPE must meet strict regulatory requirements before being placed on the EU market, including:
We assess your PPE products and regulatory requirements.
We review your technical documentation, risk assessments, and conformity data.
Formal appointment via mandate agreement
We confirm readiness for CE marking and EU market placement.
Support with regulatory updates, vigilance, and authority communication.
We support a wide range of PPE products, including:
Per Year
Ensure your smooth entry into the EU PPE market with an EURP you can trust
We assess your PPE products and review technical documentation for compliance.
Formal designation as your EU Responsible Person and confirmation of CE marking readiness.
Product ready for EU market placement with continuous regulatory and vigilance support.
Time lines can be as little as 2 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
An EU Responsible Person (EU RP) acts as the legal representative within the European Union for PPE compliance obligations where required. They ensure documentation is available, support regulatory compliance, and act as a point of contact for authorities.
Not always. Under Regulation (EU) 2016/425, responsibilities are typically held by manufacturers, importers, and authorised representatives. However, appointing an EU-based regulatory partner ensures compliance and simplifies communication with authorities.
Yes, manufacturers can change their EU Responsible Person or regulatory partner at any time by updating agreements and ensuring documentation and labelling remain compliant.
Patient Guard charges an annual fee, covering multiple PPE products placed on the EU market.
If all required documentation is available and compliant, onboarding can take as little as 2–5 business days depending on the number of products and complexity.
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
