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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.
In this presentation, we focus on one of the most outstanding EU medical device regulation changes, changes that concern strengthening the role of clinical evidence in supporting the proof of devices conformity with the relevant requirements for safety and performance.
Although majority of requirements laid down in MEDDEV Guide 2.7.1/rev. 4 were raised to the level of the »hard law«, there are some differences that require manufacturer's attention and proper data management plan. More strict requirements concern the life-cycle approach rather than focusing on the pre-marketing phase, limited options for literature search, requirements for demonstrating equivalence with the devices presented in relevant literature sources, performance of investigations, strengthened post marketing clinical follow up, appropriate planning and better defined obligations concerning updating of clinical evaluation.
