Expert regulatory support to transition your In Vitro Diagnostics from IVDD to IVDR (EU 2017/746). Based in the UK, serving global manufacturers.
IVD manufacturers placing products on the European market must prepare and maintain comprehensive technical documentation to demonstrate compliance with the EU In Vitro Diagnostic Regulation (IVDR) 2017/746.
A CE Marking Technical File is a core requirement under IVDR and must demonstrate that the device meets the applicable General Safety and Performance Requirements (GSPRs), as well as performance and safety expectations.
Patient Guard provides expert CE marking IVDR Technical File services for IVD manufacturers, supporting the preparation, review, remediation, and ongoing maintenance of IVDR-compliant documentation.
We help manufacturers build structured, audit-ready Technical Files aligned with IVDR Annex II and Annex III requirements, ensuring the latest MDCG guidance is followed and supporting notified body review where applicable.
Whether preparing new documentation, upgrading legacy files, or addressing compliance gaps, we provide a clear and compliant pathway to CE marking readiness.
This page explains Patient Guard’s IVDR Technical Documentation services, helping manufacturers prepare compliant technical documentation for CE marking under Regulation (EU) 2017/746. If you're looking for a broader introduction to the IVDR, including device classification, Performance Evaluation, General Safety and Performance Requirements (GSPRs), Risk Management, Technical Documentation and Post-Market Performance Follow-up (PMPF), read our IVDR for Beginners – A Comprehensive Guide.
We align PMPF activities with IVDR, MDCG guidance, and Notified Body expectations.
We ensure PMPF outputs support performance evaluation, PMS, vigilance, and risk management processes.
Clear project-based pricing with no hidden costs.
Providing expert regulatory affairs and quality assurance services since 2017.
We support global manufacturers across all IVD classifications from Class A through to Class D.
We design compliant PMPF plans and protocols tailored precisely to your specific device risks.
Our consultants are in-vitro diagnostic specialists, steering you accurately through the complex demands of EU Regulation 2017/746.
From low-risk Class A self-certified reagents to high-risk Class D blood-grouping assays, we manage technical documentation across all risk tiers.
We build, format, and audit technical files to match the exact presentation expectations and critique styles of leading Notified Bodies.
We don't just provide a checklist; we actively author, compile, and refine your technical documentation from scratch to submission.
We link your technical file smoothly with your existing ISO 13485 QMS, risk frameworks, and clinical evidence loops.
We build your files with long-term lifecycle safety in mind, setting up easy-to-maintain PMS and PMPF documentation structures.
Under Regulation (EU) 2017/746, manufacturers must prepare and maintain technical documentation demonstrating compliance with IVDR.
A compliant IVD Technical File typically includes:
We assess your IVD device, classification, and documentation status.
We review your existing Technical File against IVDR requirements.
We identify missing sections and compliance gaps.
We support the compilation and structuring of your Technical File.
We support final checks ahead of notified body submission or audit.
We support IVDR Technical File preparation for a wide range of IVDs, including:
| IVD Class | IVD Risk and Types |
|---|---|
| Class A | Low Risk. Non-sterile devices, laboratory instruments, and buffers |
| Class B | Moderate Individual/Low Public Risk. Includes self-test devices not in Class C or D |
| Class C | High Individual/Moderate Public Risk. Includes genetic testing, companion diagnostics, and cancer screening. |
| Class D | High Individual & Public Risk. Includes blood grouping and high-risk infectious diseases. |
Unsure of your class? Most IVDs that were self-certified under IVDD now require Notified Body involvement.
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Ensure regulatory compliance and market readiness with expertly prepared CE Marking In Vitro Diagnostic Technical Files. Pricing starts from £6,000, with preferential rates for multiple products.
Assessment of your device and existing documentation against IVDR Annex II & III requirements.
Compilation, structuring, and correction of documentation including GSPR, risk management, and performance data.
Final compliance check and preparation for Notified Body review or EU market placement.
Fast turnaround: most Technical Files are delivered within 4–8 weeks, subject to completeness of product information.
| Requirement | IVDD (Old Directive) | IVDR (New Regulation) |
|---|---|---|
| Classification | List-based | Rules-based (A, B, C, D) |
| Clinical Evidence | Weak/Literature based | Strong Clinical Evidence / PER |
| Post-Market | Basic requirement | Continuous PMS & PMPF |
| Notified Body | Only for high-risk | ~80% of all IVDs now require it |
The transition to IVDR has replaced ‘Essential Requirements’ with the more rigorous GSPR outlined in Annex I. Patient Guard provides a detailed mapping of your device’s technical documentation against these requirements. We ensure every applicable standard—from chemical and physical properties to infection and microbial contamination—is evidenced with objective data.
Under IVDR, the Performance Evaluation is a continuous process. Our experts help you compile a robust PER based on the ‘Three Pillars’ of clinical evidence:
| Pillar | What We Cover |
|---|---|
| Scientific Validity | Association of an analyte with a clinical condition or a physiological state. |
| Analytical Performance | Evidence of the device's ability to correctly detect or measure a particular analyte. |
| Clinical Performance | Ability of the device to yield results that are correlated with a particular clinical condition. |
A Technical File is a living document. We support you with Post-Market Performance Follow-up (PMPF) and the Periodic Safety Update Report (PSUR) required for Class C and D devices. Additionally, we provide full support for UKCA marking, ensuring your IVD remains compliant for the Great Britain market.
An IVD Technical File is the set of documentation required to demonstrate that an in vitro diagnostic device complies with IVDR 2017/746.
Yes, all IVDs placed on the EU market require technical documentation, with the level of detail depending on classification and risk.
It includes device description, risk management, performance evaluation, verification and validation data, GSPR compliance, labelling, and post-market documentation.
Yes, we can review and remediate existing documentation to ensure compliance with IVDR.
Timelines vary depending on device complexity and documentation availability, but initial reviews can begin within days.
Click on the links below to discover more:
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Planning to place a medical device on the US market? This complete guide explains FDA medical device regulations, including device classification, 510(k), De Novo and PMA pathways, QMSR and ISO 13485, establishment registration, device listing, U.S. Agent requirements, UDI and post-market obligations.
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.
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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