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The New Medical Devices and IVD legislation was adopted in May 2017. It brought significant changes with impact on a wide range of companies dealing with medical devices. If they want to continue to market medical devices in the EU they will have to adapt their working processes and meet new requirements. A lot of work is to be done in a short (transitional) period of time. It's a challenge also for companies planning to enter the EU market.
Medical devices companies should make their regulatory strategy their priority and gain the knowledge and understanding of the new rules and requirements and make an individual plan for achieving the compliance.
Gaining knowledge and understanding of over 600 pages of the new legislation related to medical devices and IVD require significant time, efforts and resources, but it's a precondition for proper planning and performing your activities.
Our pool of seminars is designed to save time and resources and enable you quick and simple understanding of EU rules and requirements on medical devices.
The new legislation on medical devices will have impact on almost all medical devices and companies dealing with them. The introduced changes will only apply after a transitional period. Although the transitional period seems like a long time, some changes require an early start of activities necessary for smooth transition from the old to the new rules and requirements and their proper implementation. Awareness of and understanding the changes is crucially important for proper planning compliance activities. Not all the changes are equally relevant for all companies, but better understanding of a big picture improves understanding the details.
This seminar brings an overview of the major changes and reasoning behind them. It will help you in a simple and comprehensive way to understand the changes and enable you to see a big picture, not to focus only to the isolated changes that have the biggest impact to your company. Better understanding of the whole and the reasoning behind, enables better planning and responses to the changing environment.
