The new Regulations on medical devices and in-vitro diagnostic medical devices were published in the Official Journal of the European Union on May 5th, 2017 and now replace the existing Directives.
The new Regulations contain a series of extremely important updates, such as the reinforcement of the criteria for designation and processes for oversight of Notified Bodies, the revision of risk classification rules for medical devices and the introduction of a new risk classification system for in vitro diagnostic medical devices, improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification, the strengthening of post-market surveillance requirements for manufacturers and improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
The new rules will apply after a transitional period, namely 3 years for medical devices and 5 years for in vitro diagnostic medical devices.
A proper planning of the activities is advisable. Regulatory Pharma Net team and experts are available to support companies to comply with the new requirements.