WHY I SHOULD JOIN THE WEBINAR:
Before placing a medical device on the European market, manufacturers need to produce technical documentation as evidence of conformity to the relevant legislation. This documentation plays a vital role as it contains information on how the device was developed and how it has evolved during the production run.
A CE Technical File is a comprehensive description of your device, intended to demonstrate compliance with European requirements. The Technical File has to be developed during the design and development process of a device and maintained throughout its entire life cycle. Compiling your Technical File is a critical step in Europe’s CE Marking Process and a requirement for compliance with the Medical Devices Directive 93/42/EEC and the new Medical Devices Regulation MDR 2017/745.
The Technical File should be clear, well organized and unequivocal. It includes detailed information about the design, function, composition, use, claims, clinical evaluation and other features of a medical device. Technical File is required for all classes of devices (Class I, IIa, IIb and III) and the type of device dictates the specific information and layout included therein. The Technical File must be reviewed by the Notified Body during the conformity assessment of the device, except for Class I devices. In addition, the Technical File shall be available upon request to any EU Competent Authorities. Understanding how to assemble these information and present it for review by Notified Bodies is essential.
This webinar will provide essential guidance on the content of the technical documentation file, the changes required and the essential aspects necessary for compiling and maintaining the technical file to comply with the MDR. Delegates will learn what documentary evidence is required in order to demonstrate a product’s conformity to the essential principles of safety and performance. Our expert will offer delegates advice, guidance and best practice on the detail of information required to assist you through the regulatory submission process.
- Technical documentation requirements according to EU MDR 2017/745
- General requirements using relevant harmonized standards
- Process definition for the creation and maintenance of compliant technical files
- Technical File structure
- Practical advice on how to manage the life cycle of the technical file
WHO SHOULD PARTICIPATE:
- Regulatory affairs & QA experts
- Research, design & manufacturing engineers
- Experts involved in the evaluation of Medical Devices
- Product Managers & Laboratory Managers
- Process development & system engineers
EVENT KEY NOTE SPEAKER:
Senior Consultant at Eurofins Medical Devices Italy
** Israel Time Zone