GETTING READY FOR MAY 2020
Until now, the medical device market was regulated by European directives. The transposition of these directives according to the legislation of each country was mandatory but left some freedom of interpretation.
In May 2017, a European regulation was published with the aim of harmonizing the different legislations for the marketing of medical devices. It will come into force in May 2020. It results in an increase in the number of products covered and the modification of classes for some Medical Devices already certified.
The classification step is crucial. Indeed, it will determine the process to follow for obtaining the CE certificate.
What are the main regulatory developments? What are the steps for obtaining the CE marking?
Sales representative - Cosmetics & Medical Devices