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Technical documentation needs to be in compliance with the Medical Devices Directive (MDD) 93/42/EEC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (referred to as ‘MDD/AIMDD’ hereafter).
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR.
This Technical Documentation submission guidance is aligned to the requirements of (EU) 2017/745 Medical Devices Regulation (MDR), described in detail in Annexes II and III of (EU) 2017/745.
The MDR 2017/745 requires new standards for the technical documentation of medical devices and requires a conversion from traditional to MDR-compliant approaches. Key points are the Design History File (DHF), which documents development processes, and the technical dossier, which includes clinical evaluation and post-market studies.
Information to allow key design stages to be understood. Description of manufacturing processes. Manufacturing validations, monitoring and final product testing. Identification of all suppliers and sub-contractors undertaking design or manufacturing processes for the manufacturer.
12 sty 2024 · Before a medical device can be legally sold, its technical file must be prepared and submitted as part of the conformity assessment process. The file is essential for demonstrating compliance with relevant regulatory requirements, such as the European Medical Device Regulation (MDR).
MDR Technical Documentation (TD) Checklist. To help you to compile a complete TD which supports an efficient and timely assessment, TÜV SÜD Medical Health Services created a guidance document: Summary of MDR TD.
