Changes in regulatory framework for medical devices

On the 7th March 2017, the Council of the European Union voted to adopt two regulations concerning medical devices and in vitro diagnostic medical devices. If The European Parliament also votes them into law, it will bring about key changes particularly in surveillance procedures of medical devices.
The projects involve in particular strengthening the powers of notified bodies in the process of placing medical devices on the market. Moreover the manufacturers would have to establish quality management system guaranteeing continuous safety surveillance, among others via: 

•    designating at least one person responsible for regulatory compliance of a medical device, 
•    assigning unique identifiers to the products and 
•    establishing a post market surveillance system which should be proportionate to the risk class and the type of the device in question.

The texts will be voted by the European Parliament in April.
The full texts are available under the following links: 
http://data.consilium.europa.eu/doc/document/ST-10728-2016-REV-3/en/pdf
http://data.consilium.europa.eu/doc/document/ST-10729-2016-REV-3/en/pdf