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Understanding Instructions for Use of Medical Devices and Providing Support in Their Drafting

Level:
Foundation
Area:
Medical Devices
Code:
MDF5
Duration:
03:00:00
Workshop profile:
This workshop is intended for medical writers with basic or very little knowledge in regulatory writing under either the Medical Devices Directive 93/42/EEC (MDD) or under the Medical Devices Regulation 2017/745 (MDR).
Objective:
The Medical Devices Regulation 2017/745 (EU MDR) sets out new requirements for IFUs. For legacy devices, part of the content of the IFUs may come from the Clinical Evaluation of the device, while for new devices it may come from clinical investigation plans conducted before marketing authorization. Medical writers are essential to support manufacturers in writing clear and useful IFUs. These documents are subject to predefined review cycles and depend on several other input documents. This workshop will give you profound insights into the regulatory requirements for IFUs, best practice recommendations on how to draft IFUs, and insights into common pitfalls and tips on how to avoid them.
Content:
The course includes the following topics: - Regulatory framework: EU MDR 2017/745 requirements and definitions - Content and structure of the Instructions for Use - Where do all those contents come from? Legacy devices vs new devices - Recommendations for the writing process: Tips to improve writing of the IFUs - Usability and readability - Images, photos and symbols - Where else and how the content of IFUs is used. We will navigate through many examples about content, writing and possible pitfalls. You will get insights on how to improve the quality of IFUs and contribute to the drafting process.