Your mandatory legal presence for placing PPE on the Great Britain market. We ensure your products meet UKCA requirements and the PPE Regulations 2016 (as amended)
PPE manufacturers based outside Great Britain (UK) must appoint a UK Authorised Representative (UKAR) to legally place products on the GB market under the Personal Protective Equipment Regulations 2016 (as amended).
A UK Authorised Representative acts as your legal presence within the UK, ensuring compliance with regulatory requirements, including technical documentation, conformity assessment support, and post-market obligations.
Patient Guard acts as your UK PPE regulatory consultancy, ensuring full compliance with UK PPE regulations and smooth access to the GB market.
Without a UK-based representative, non-UK manufacturers cannot legally place PPE on the GB market or meet UKCA regulatory requirements.
Patient Guard provides expert UK Authorised Representative services for PPE manufacturers worldwide. We support technical file reviews, UKCA compliance, labelling verification, and ongoing regulatory obligations.
Whether launching a new product or transferring from an existing UKAR, we ensure a smooth and compliant route to UK market access.
Our consultants possess deep knowledge of the Personal Protective Equipment Regulation (EU) 2016/425, ensuring your products fully meet stringent European standards.
With our dedicated office established in Germany, we provide a seamless, legally robust EU Authorised Representative gateway for non-EU PPE manufacturers.
We act as your direct, professional point of contact for European Market Surveillance Authorities, handling all official inquiries and compliance checks smoothly.
We systematically verify your compliance infrastructure, protecting your business from costly market enforcement actions, border delays, or product recalls.
Since 2017, hundreds of global manufacturers have trusted our professional services to secure and maintain their compliance status.
We don't just hold your files; we provide active technical file monitoring, CE marking/label reviews, and regulatory updates as EU standards evolve.
Thoroughly reviewing your PPE technical documentation, risk assessments, and test reports to ensure total alignment with Regulation (EU) 2016/425.
Verifying and keeping up-to-date copies of your formal EU Declaration of Conformity readily available for regulatory inspection.
Serving as your designated legal entity to receive, process, and respond directly to regulatory requests from European competent authorities.
Reviewing product packaging, CE marking scales, importer details, tracking codes, and instructions for use (IFU) for strict compliance.
Assisting your team with corrective action tracking and managing communications if safety complaints or compliance anomalies arise in the EU market.
Proactively monitoring European Harmonised Standards updates to guarantee your PPE product lines maintain continuous market access without disruption.
Under the Personal Protective Equipment Regulations 2016 (as amended), a UK Authorised Representative is responsible for ensuring that PPE products comply with regulatory requirements, 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 UKCA marking and 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 UK PPE market with an UKAR you can trust
We assess your PPE products and review technical documentation for compliance.
Formal designation as your UK Authorised Representative and confirmation of UKCA readiness.
Product ready for GB 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.
A UK Authorised Representative (UKAR) acts as the mandatory legal representative for non-UK PPE manufacturers placing products on the Great Britain market. They ensure compliance with UK regulations, maintain technical documentation access, and support post-market surveillance.
Yes, all manufacturers based outside the UK must appoint a UK Authorised Representative to place PPE on the GB market. The UKAR must be established in the UK and assumes responsibility for regulatory compliance.
Yes, a PPE manufacturer can change their UK Authorised Representative at any time. This involves terminating the existing agreement, appointing a new UKAR, updating documentation and labelling, and ensuring continuity of compliance.
Patient Guard charges an annual fee, covering multiple PPE products placed on the GB market.
If all required documentation is available and compliant, the process can take as little as 2–5 business days. Timelines depend on the number of products and complexity of documentation.
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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.
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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.
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