Our CE Marking Technical File services support medical device manufacturers in preparing compliant technical documentation for CE marking under the EU Medical Device Regulation (EU) 2017/745. Patient Guard helps you compile, review, and strengthen your Technical File to support conformity assessment and successful EU market access.
Medical device manufacturers placing products on the European market must prepare and maintain comprehensive technical documentation to demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745.
A CE Marking Technical File is a core regulatory requirement for medical devices and provides the documented evidence needed to demonstrate that a device meets the applicable General Safety and Performance Requirements (GSPRs).
Patient Guard provides expert CE Marking Technical File services for medical device manufacturers, supporting the preparation, review, remediation, and ongoing maintenance of MDR-compliant technical documentation.
We help manufacturers build structured, audit-ready Technical Files that align with MDR Annex II and Annex III requirements and support notified body review where applicable.
Whether you are preparing a new Technical File, updating legacy documentation, or addressing identified gaps, we ensure a clear and compliant route to CE marking readiness.
Under Regulation (EU) 2017/745, manufacturers must prepare and maintain technical documentation that demonstrates conformity with the applicable requirements of the MDR.
A compliant Technical File for a medical device typically includes:
We assess your device, classification, and current documentation status.
We review your existing Technical File or source documents against MDR requirements.
We identify missing sections, weak justifications, and documentation gaps.
We help compile, revise, and structure the Technical File for compliance.
We support final checks ahead of submission, audit, or notified body review.
We support Technical File preparation for a wide range of medical devices, including:
From
Ensure regulatory compliance and market readiness with expertly prepared CE Marking Medical Device 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 clinical 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.
A CE Marking Technical File is the set of technical documentation required to demonstrate that a medical device complies with the applicable requirements of the EU Medical Device Regulation (EU) 2017/745.
Yes, all medical devices placed on the EU market require technical documentation. The scope and complexity depend on the device classification, intended purpose, and applicable conformity assessment route.
A Technical File typically includes device description, design and manufacturing information, risk management, GSPR compliance, verification and validation data, clinical evaluation, labelling, and post-market surveillance documentation.
Yes, we can review your current Technical File, identify compliance gaps, and help remediate the documentation to align with MDR requirements.
Timelines depend on the complexity of the device and the availability of supporting documentation. Where the source documentation is already available, review and remediation can begin immediately.
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2026 represents a significant milestone for the amended IVDR transitional provisions framework.
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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