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.
This page explains Patient Guard’s PPE Authorised Representative service for manufacturers placing Personal Protective Equipment (PPE) on the UK market. If you're looking for a broader introduction to PPE compliance, including Regulation (EU) 2016/425, UK regulatory requirements, CE and UKCA marking, conformity assessment, technical documentation and the responsibilities of manufacturers and Authorised Representatives, read our PPE Regulation for Beginners Guide.
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.
Click on the links below to discover more:
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.
Before a cosmetic product can legally be placed on the UK market, manufacturers and Responsible Persons must demonstrate that it is safe for human use under normal or reasonably foreseeable conditions. The Cosmetic Product Safety Report (CPSR) is one of the most important regulatory documents required under the UK Cosmetics Regulation. This guide explains what a CPSR is, who can prepare one, what information it must contain, how it relates to the Product Information File (PIF) and how it supports legal cosmetic compliance.
Post-Market Performance Follow-up (PMPF) is a fundamental requirement under the EU In Vitro Diagnostic Regulation (IVDR), ensuring that manufacturers continually monitor the scientific validity, analytical performance and clinical performance of their in vitro diagnostic medical devices after CE marking. This guide explains IVDR PMPF requirements, PMPF Plans, PMPF Reports, Annex XIII expectations and how ongoing performance monitoring supports continued regulatory compliance throughout the device lifecycle.
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
Thank you! The checklist is now ready to download.
