Why Your Medical Device Technical File
Must Be Compliant?
Legal background
Without a compliant technical file, your product cannot legally be placed on the EU market. Errors or omissions in the file may delay your CE marking process, trigger costly audits, or even lead to market withdrawal. Keeping your documentation complete and aligned with current regulatory requirements is critical to avoiding disruptions and safeguarding your product’s success in Europe. Technical file for medical devices and IVDs is essential for seamless EU market entry, long-term product success, and regulatory peace of mind.
A properly reviewed and up-to-date technical file:
- Proves conformity with MDR or IVDR.
- Ensures faster, smoother interactions with Notified Bodies.
- Minimizes the risk of non-compliance and recalls.
- Demonstrates commitment to quality and patient safety.
Our services
How Obelis Supports Your Technical File Compliance
Obelis provides expert Technical File Review services for manufacturers of medical and IVD devices seeking EU market access. We verify that your documentation meets all MDR or IVDR requirements, offer detailed guidance on what needs to be included for your specific product, assist in drafting or refining critical sections such as clinical evaluations, and help identify the right Notified Body if needed. With Obelis, you gain confidence that your technical file is complete, compliant, and ready to support your CE marking process. We make sure that regulatory compliance is at the highest level and without unnecessary complications.
Whether you are compiling a new file or revising one during a lifecycle update, Obelis ensures your technical documentation is audit-ready, CE-compliant, and aligned with EU expectations.
FAQ
Frequently Asked Questions
A Technical File Review is a comprehensive assessment of your medical device or in vitro diagnostic device documentation to ensure it complies fully with the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This review verifies that your technical file is complete, well-structured, and aligned with current regulatory requirements, supporting your product’s conformity assessment and CE marking.
Conducting a Technical File Review is essential to identify and correct any gaps or errors that could delay your CE certification, trigger audits, or risk market withdrawal. A compliant, up-to-date technical file demonstrates conformity with MDR or IVDR, facilitates smoother interactions with Notified Bodies, and ultimately safeguards your product’s legal access to the EU market.
The review covers all critical documentation required by MDR or IVDR, including but not limited to:
- Device description and specifications
- Risk management files
- Clinical evaluation reports
- Manufacturing processes and quality management systems
- Labelling and instructions for use
- Post-market surveillance plans
- Test reports and verification/validation data
Obelis performs a detailed, expert assessment of your entire technical documentation. We identify missing or incomplete elements, advise on regulatory expectations specific to your device class, and support drafting or refining key sections such as clinical evaluations. We also assist in selecting a suitable Notified Body if required. Our goal is to ensure your file is audit-ready, fully compliant, and optimised for a smooth CE marking process.
