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EU Responsible Person & Authorised Representative for PPE

Your mandatory legal presence in the European Union. We act as your EU Responsible Person under Regulation (EU) 2019/1020, ensuring your PPE is compliant with Regulation (EU) 2016/425 for seamless market access.

500+ Manufacturers Supported

BSI ISO 13485 Certified

UK & EU Offices

Former MHRA Expertise

Established 2017

EU Responsible Person (EU RP) Services for PPE

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.

David Small - Patient Guard - CEO and Founder

"Navigating EU PPE Regulation 2016/425 from the outside requires a partner who understands the nuances of European market surveillance. By acting as your Responsible Person, we provide a sophisticated bridge between your manufacturing standards and the high safety expectations of EU authorities."

David Small BSc (Hons), MSc, MTOPRA

Founder and CEO

Why Choose Patient Guard as Your EU Responsible Person?

Transparent Pricing

We provide clear annual pricing packages with absolutely no hidden fees, helping you manage your regulatory overhead predictably.

Established Regulatory Consultancy

Operating as a trusted partner since 2017, our specialists have supported global manufacturers with EU compliance for over 9 years.

Trusted by 500+ Companies

We actively support start-ups, agile SMEs, and established global brands with complex PPE compliance frameworks and EU market access.

Responsive Regulatory Support

Our European compliance experts deliver fast, reliable technical support when dealing with EU authorities and market requests.

What Our EU Responsible Person Service Includes

Formal EU RP Designation

We act as your official EU Responsible Person under a formal mandate agreement, anchoring your regulatory presence within the Union.

Technical File Verification

Reviewing your technical files to ensure full compliance with Regulation (EU) 2016/425, including risk profiles and conformity metrics.

CE Marking Support

Supporting all necessary compliance routes with CE marking requirements, including data checks and conformity pathway evaluations.

Compliance Verification

Systematically verifying that your personal protective equipment meets all harmonised EU directives before placing it onto the market.

EU Authority Liaison

Serving as your designated professional point of contact for National Competent Authorities within the European Union territory.

Post-Market & Vigilance

Providing direct lifecycle support for critical incident reporting, field safety corrective actions (FSCA), and ongoing compliance upkeep.

Who Requires an EU Responsible Person?

EU PPE Regulatory Requirements

Under Regulation (EU) 2016/425, PPE must meet strict regulatory requirements before being placed on the EU market, including:

CE marking compliance
Technical documentation availability
EU Declaration of Conformity (DoC)
Labelling and traceability requirements
Conformity assessment procedures (Notified Body where applicable)
Post-market surveillance and vigilance

Our Process

Consultation

We assess your PPE products and regulatory requirements.

Documentation Review

We review your technical documentation, risk assessments, and conformity data.

EU RP designation

Formal appointment via mandate agreement

Compliance verification

We confirm readiness for CE marking and EU market placement.

Ongoing Compliance

Support with regulatory updates, vigilance, and authority communication.

PPE types we support

We support a wide range of PPE products, including:

Respiratory protective equipment (masks, respirators)
Protective clothing (gowns, coveralls)
Eye and face protection (goggles, face shields)
Hand protection (gloves)
Hearing protection
Safety footwear and helmets

Cost of Service

Premium

EU Responsible Person Service PPE

£ 1000

Per Year

Ensure your smooth entry into the EU PPE market with an EURP you can trust

Features

CE Marking Compliance Support
Official EU Responsible Person
Fast Onboarding
Ongoing Regulatory Support

Get Started

Time Lines

Day 1–2 – Initial Consultation & Documentation Review

We assess your PPE products and review technical documentation for compliance.

Day 2–4 – EURP Appointment & Compliance Verification

Formal designation as your EU Responsible Person and confirmation of CE marking readiness.

Day 5+ – Market Access & Ongoing Support

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

Frequently Asked Questions (FAQs)

What does an EU Responsible Person do?

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.

Do all manufacturers need an EU Responsible Person for PPE?

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.

Can the manufacturer change their EU Responsible Person?

Yes, manufacturers can change their EU Responsible Person or regulatory partner at any time by updating agreements and ensuring documentation and labelling remain compliant.

How much does the EU Responsible Person service cost?

Patient Guard charges an annual fee, covering multiple PPE products placed on the EU market.

How long does the process take?

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.

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Recent Blog Posts

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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.

DTAC Requirements Explained: The 5 Areas Digital Health Manufacturers Need to Get Right

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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.
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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.
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For digital health manufacturers, the practical question is therefore not simply:
“Can we complete the DTAC assessment?”
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The Complete Guide to NHS DTAC Compliance for Digital Health Manufacturers

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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.

Cosmetic Product Safety Report (CPSR): A Complete Guide to UK Cosmetic Compliance

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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.

IVDR PMPF Explained: A Complete Guide to Post-Market Performance Follow-up

August 24, 2026 No Comments

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.

IVDR Scientific Validity Explained: A Complete Guide for Manufacturers

August 17, 2026 No Comments

Scientific Validity is the first pillar of IVDR Performance Evaluation and provides the scientific foundation demonstrating that an analyte or biomarker is associated with a specific clinical condition or physiological state. This guide explains Scientific Validity under Regulation (EU) 2017/746, including literature reviews, Scientific Validity Reports, Annex XIII requirements, evidence appraisal and how Scientific Validity supports successful CE marking.

      
   Patient Guard Ltd
   10 Google reviews 
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      Posted on Google  
   
   Jay Verma 
 15 days ago
 
 
 Trustindex verifies that the original source of the review is Google. I found Patient Guard Ltd to be an exceptional partner. Their assessment was thorough, their guidance clear, and their support instrumental in helping us achieve our objectives. Steve and Ellie, in particular, were outstanding in steering us through the MHRA Class I medical device registration process.
  
 
     Posted on Google  
   
   Munna P 
 68 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Working with the Patient Guard team has been a great experience throughout our MHRA and ISO 13485 documentation journey. Their expertise, structured approach, and practical guidance helped our team build a robust quality management system while keeping us aligned with regulatory expectations. The collaboration was professional, responsive, and focused on finding solutions rather than simply identifying issues. A special thank you to Alex and Steve for their outstanding coordination, responsiveness, and continuous support throughout the project. They were always approachable, provided valuable feedback, and worked closely with our team to resolve challenges efficiently. Their commitment made a significant difference in keeping our documentation effort on track. I highly recommend Patient Guard to any healthcare or MedTech organization looking for experienced regulatory and quality system partners for MHRA, ISO 13485, and broader medical device compliance initiatives. Thank you again to the entire Patient Guard team for being such reliable partners.
  
 
     Posted on Google  
   
   Peter Reeve 
 94 days ago
 
 
 Trustindex verifies that the original source of the review is Google. STEPPER design, manufacture & distribute eyewear across the globe.  With the increasingly complex landscape concerning the placing of Mecial Devices onto the market, we realised we needed professional guidance. We found Patient Guard via a simple internet search and are delighted we did! They provide a pragmatic solution to our needs, are totally reliable & always available to answer our (often simplistic) questions. They are highly efficient & responsive to what is a changing picture in our world and nothing is too much trouble. We have a much better understanding of regulatory affairs and our responsibilities as manufacturers & distributors and they support us in navigating the requirements in different territories. Updating our Declaration of Conformity, ensuring our labelling is compliant and acting as our PRRC are the key areas of their service for us.
  
 
     Posted on Google  
   
   Derek Timm 
 95 days ago
 
 
 Trustindex verifies that the original source of the review is Google. For those companıes lookıng to comply to ISO standards and ın partıcular ISO13485 whıch to be honest ıs a nıghtmare I would strongly suggest goıng to the professıonals as ındeed we dıd by joınıng forces wıth Patıent Guard Ltd   The staff are fantastıc  nothıng ıs too much trouble and as a medıcal supply company we sımply cannot lıve wıthout them  Thanks ın partıcular to Alex and Steve for all the hard work and our best regards from Dan Medıca South Lımıted
  
 
     Posted on Google  
   
   BMSCriticalCare 
 132 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Great service, very helpful and always willing to answer any questions we have,
  
 
     Posted on Google  
   
   Thomson Software 
 803 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Alex Lewis of PatientGuard guided us through the ISO13485 process in a thorough, systematic and efficient manner.  He was friendly, patient and willing to go the extra mile.  Excellent service.
  
 
     Posted on Google  
   
   Hannah Maddison 
 906 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Fantastic, knowledgeable team that are always there to help.  My appointments have always been booked in very promptly and have always ended with all my queries resolved.  I have found the team very flexible and their breadth of knowledge is second to none.  Patient Guard are without doubt my go-to for all the regulatory aspects of my medical device role.
  
 
     Posted on Google  
   
   Richard Crow 
 941 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Patientguard are an excellent source of Medical regulatory compliance advice, we have taken advantage of their various services from their EU Rep service, to helping with Technical Files all the way through to using their ISO Templates to implement our ISO 13485 system.
  
 
     Posted on Google  
   
   George Kitching 
 944 days ago
 
 
 Trustindex verifies that the original source of the review is Google. David Small and PatientGuard have been extremely helpful and supportive in assisting us with producing and updating our Technical File and Appendices for MDR certification.
  
 
     Posted on Google  
   
   Tracey Slater 
 944 days ago
 
 
 Trustindex verifies that the original source of the review is Google. Patient Guard have been a great support service to Cormed, providing help and advice promptly when ever requested.  They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.
  
 
 
  
 
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