8/30/2023 0 Comments Ce technical file sample![]() ![]() Please get in touch for further information! Checklists, templates and useful links regarding Technical Files You are also invited to make use of our extensive expert network should you require in-depth support. You may find these and corresponding information, using the links below. Mdi Europa set up a checklist and template to assist manufacturers in the compilation of their Technical Files. In addition, a separate annex III has been dedicated to Post-Market Surveillance (PMS) requirements for the Technical Documentation. Benefit-risk analysis and risk management.General Safety and Performance Requirements.Information to be supplied by the manufacturer.Device description and specifications including variants and accessories. ![]() Under the MDR (EU) 2017/745 and IVDR (EU) 2017/746, requirements have been expanded and substantiated: Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements on Technical Files Mdi Europa will help you to comply with the necessary legislation and assist in ensuring that your Technical File is ready for review by a Notified Body (as and when necessary) or the local competent authorities in Europe. A Technical File – often referred as Technical Documentation – is required for all products falling under the medical devices legislation, including low risk class I medical devices, low risk in vitro diagnostic (IVD) medical devices and custom made devices.
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