EU Technical Documentation
The CE Medical Devices Regulation (MDR & IVDR) is a significant regulatory framework that governs the marketing and use of medical devices in the European Union (EU). It was introduced to replace the previous Medical Devices Directive (MDD) and aims to enhance patient safety and improve the overall efficiency of the medical device approval process.
The CE MDR & IVDR represents a comprehensive overhaul of medical device regulations in the EU, designed to improve patient safety, foster innovation, and streamline market access for medical devices. Compliance with the MDR is essential for all medical device companies operating in the European market.
Under Annex II of the CE Medical Devices Regulation (MDR & IVDR), technical documentation is a crucial requirement for manufacturers seeking to obtain the CE mark for their medical devices. Technical documentation serves as evidence that the device complies with the essential requirements of the MDR and is safe and effective for its intended use. It is a comprehensive collection of information and data about the medical device and its manufacturing process.
Complying with the requirements for technical documentation under Annex II is essential for manufacturers to demonstrate the safety and effectiveness of their medical devices and to obtain the CE mark, allowing them to legally place their devices on the European market.
We provide technical support to assist in the preparation of the Technical Documentation for compliance with the CE Medical Devices Regulation (MDR & IVDR).
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