Our CE Marking Technical File services support in vitro diagnostic (IVD) manufacturers in preparing compliant technical documentation under the EU In Vitro Diagnostic Regulation (EU) 2017/746. Patient Guard helps you compile, review, and strengthen your Technical File to support conformity assessment and successful EU market access.
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 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, 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.
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 Technical File preparation for a wide range of IVDs, including:
From
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.
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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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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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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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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