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.
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 MDR 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.
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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
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.
UK Office
Thank you! The checklist is now ready to download.
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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