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.
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.
This page explains Patient Guard’s EU Responsible Person service for manufacturers placing Personal Protective Equipment (PPE) on the European market. If you're looking for a broader introduction to PPE compliance, including Regulation (EU) 2016/425, CE marking, risk categories, conformity assessment, technical documentation and economic operator responsibilities, read our PPE Regulation for Beginners Guide.
We provide clear annual pricing packages with absolutely no hidden fees, helping you manage your regulatory overhead predictably.
Operating as a trusted partner since 2017, our specialists have supported global manufacturers with EU compliance for over 9 years.
We actively support start-ups, agile SMEs, and established global brands with complex PPE compliance frameworks and EU market access.
Our European compliance experts deliver fast, reliable technical support when dealing with EU authorities and market requests.
We act as your official EU Responsible Person under a formal mandate agreement, anchoring your regulatory presence within the Union.
Reviewing your technical files to ensure full compliance with Regulation (EU) 2016/425, including risk profiles and conformity metrics.
Supporting all necessary compliance routes with CE marking requirements, including data checks and conformity pathway evaluations.
Systematically verifying that your personal protective equipment meets all harmonised EU directives before placing it onto the market.
Serving as your designated professional point of contact for National Competent Authorities within the European Union territory.
Providing direct lifecycle support for critical incident reporting, field safety corrective actions (FSCA), and ongoing compliance upkeep.
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:
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.
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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.
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.
Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.
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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