Technical Documentation

EU Authorised Representation and Regulatory Solutions for Medical Devices and IVDs.

Expert Technical File Review

The EU MDR and IVDR set strict requirements for medical device manufacturers, requiring comprehensive technical documentation to demonstrate safety, performance, and quality compliance.

At Medunion, our technical file review services focus on critical elements including design and manufacturing data, risk management, clinical evaluation, post-market surveillance, labeling, and instructions for use. We ensure your documentation aligns with MDR/IVDR standards and provide detailed, actionable feedback to support full regulatory compliance.

Tailored Solutions

At Medunion, we help you bridge gaps and strengthen the quality of your technical documentation to meet EU MDR and IVDR standards. Our support is tailored to your product’s risk class, intended use, and regulatory pathway. Typical areas we assist with include:

Device Classification & Conformity Strategy
Determining the appropriate classification and selecting the correct conformity assessment procedure.
Applicable Standards & Regulatory References
Identifying relevant harmonized standards and MDCG guidance for your device type.
Design & Development Documentation
Support with design inputs, outputs, reviews, verifications, and validations.
Test Report Review & Modernization
Evaluation of existing reports with recommendations for alignment to current “state of the art” requirements.
Intended Use Evidence
Justification and documentation of indications and contraindications based on scientific and clinical data.
Clinical & Performance Evaluation
Gap analysis, literature review, and preparation of Clinical Evaluation Reports (CER) or Performance Evaluation Reports (PER).
Risk Management
Risk file development and alignment with EN ISO 14971, integrated with the overall technical file.
Labelling & IFU Compliance
Comprehensive review of labeling, symbols, packaging, and Instructions for Use (IFU) to ensure regulatory accuracy.
Post-Market Surveillance
Assistance with PMS, PMCF, or PMPF activities—including planning, execution, and documentation.
Biocompatibility & Hazardous Substances
Review of biological safety and use of CMR/ED substances, with alignment to Annex I requirements.
Quality Management System Integration
Ensuring that your ISO 13485:2016 documentation supports and feeds into the technical file structure.
Specialist Device Support
Regulatory guidance for high-risk or complex devices, including those incorporating medicinal substances or non-viable human/animal tissues.

Expertise that drives your success

We offer global expertise in the approval and registration of medical devices.
Whether you need guidance on MDR compliance or full project support, we’re here to answer your questions and assemble a dedicated team tailored to your specific regulatory needs.