You have no items in your shopping cart.
z
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. One of the most outstanding changes concerns strengthening requirements for clinical confirmation of product’s compliance with the new legislation.
This presentation is aimed at facilitating the process of identifying gaps between the existing clinical documentation and the new requirements or in other words checking if the existing documentation adequately confirms product’s conformity with relevant general safety and performance requirements. If we mind the differences, we’ll better identify the gaps.
It is a step by step approach starting with differences between essential requirements laid down in the medical device directives and the new requirements for safety and performance. The next step we’ll guide you through is identifying differences between the requirements laid down in guidelines MEDDEV 2.7.1/Rev 4 and PMCF MEDDEV 2.12.2/rev 2 and MDR requirements. The further step is to identify documentation gaps by using check list based on Annex XIV MDR requirements. The remaining gaps should be fulfilled by the missing data from new literature search in line with MDR requirements and by generating the new data from manufacturer’s PMS and/or from own clinical investigation.
