BEXEN MEDICAL CONFERENCE FOR THE BASQUE HEALTH CLUSTER

On Thursday 14th February, Gorka Ramírez, Technical and Health Consulting Director at Bexen medical took part in the seminar “Application of Regulation (EU) 2017/745 on medical devices: new times, new challenges” organised bythe BASQUE HEALTH CLUSTER, giving a talk about the challenges and different procedures facing companies when it comes to obtaining CE certification.

New European regulations on medical devices will come into force in May 2020, and this will entail immediate strategic changes in the manufacturing and marketing of products by companies in this sector.

In this context, the content of the Regulation was analysed during the conference, and a road map was drawn up, based on the new classification of products and devices, and the outline of the technical documentation currently in force under Directive 93/42/EEC on medical devices.