Why Your Technical File Needs to Stay Compliant
Legal background
A complete and compliant technical documentation file is essential for placing a medical device on the Great Britain market. Under UK MDR, manufacturers must prepare their technical documentation before issuing the Declaration of Conformity, retain it for at least 5 years after the last device is manufactured, and make it available to the MHRA upon request.
The benefits of a compliant technical file
Why regular technical documentation reviews matter
Demonstrates compliance
Proves your device meets UK MDR requirements and supports regulatory conformity.
Supports Approved Body reviews
Ensures smoother and more efficient interactions with Approved Bodies and regulators.
Reduces regulatory risk
Minimises the likelihood of non-compliance, enforcement actions, and product recalls.
Protects quality and trust
Demonstrates your commitment to patient safety, product quality, and long-term market access.
Our services
How Obelis Supports Your Technical File Compliance
Obelis provides expert Technical File Review services for manufacturers of medical devices and IVDs seeking access to the UK market. We check that your documentation meets all applicable UK regulatory requirements, offer detailed guidance on what your specific product needs to include, help draft or refine key sections such as clinical evaluations, and support you in identifying the right Approved Body where required.
With Obelis, you can be confident that your technical file is complete, compliant, and ready to support your UKCA marking process, with regulatory compliance maintained at the highest standard and without unnecessary complications.
Whether you’re compiling a new file or updating one as part of a lifecycle review, Obelis ensures your technical documentation stays audit-ready and aligned with UK regulatory expectations.
1
Step 1
Documentation Assessment
We review your technical documentation against the applicable UK MDR requirements for your medical device or IVD.
2
Step 2
Gap Analysis
We identify missing information, compliance gaps, and opportunities to strengthen your technical file.
3
Step 3
Technical File Optimisation
We help refine key sections, verify supporting evidence, and ensure your file is UKCA marking and Approved Body ready.
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Step 4
Compliance Support
We keep your technical documentation audit-ready and aligned with evolving UK regulatory requirements throughout your product's lifecycle.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
A technical file is the collection of technical documentation demonstrating that a medical device or IVD complies with the UK Medical Devices Regulations (UK MDR). It contains evidence of the device’s safety, performance, and conformity, making it a fundamental requirement for UKCA marking and placing a product on the Great Britain market.
A technical file review helps verify that your technical documentation is complete, accurate, and compliant with UK MDR requirements. A properly reviewed technical file supports UKCA marking, facilitates assessments by an Approved Body, and reduces the risk of regulatory findings, product recalls, or delays in accessing the Great Britain market.
Under UK MDR, manufacturers must prepare their technical documentation before issuing the Declaration of Conformity and retain it for at least five years after the last device has been manufactured. The MHRA or other Competent Authorities may request access to the technical file at any time to verify regulatory compliance.
A technical file review evaluates whether your documentation meets the applicable UK MDR requirements for your medical device or IVD. This typically includes reviewing the technical documentation, identifying missing information, assessing sections such as clinical evaluation, confirming readiness for UKCA marking, and supporting interactions with the appropriate Approved Body where required.