MEPs voted to adopt new regulations concerning medical devices

European Parliament voted into law two regulations concerning medical devices and in vitro diagnostic medical devices. The drafts were previously adopted by the Council of the European Union and the legislation process has therefore come to an end. The medical devices market will face important changes. 

The regulations introduce various modifications in relation to safety and quality surveillance procedures concerning medical devices, in particular they strengthen the powers of notified bodies and impose new obligations upon manufacturers.

For instance the manufacturers will have to designate at least one person responsible for regulatory compliance of a medical device and establish a post market surveillance system which should be proportionate to the risk class and the type of the device in question. Moreover each medical device will be marked with an unique identification number in order to improve patient safety. The new regulations will also impose tighter controls on clinical trials and high-risk devices, including implants. 

The new rules will apply after transitional periods, namely 3 years after publication for the Regulation on medical devices and 5 years after publication for the Regulation on in vitro diagnostic medical devices. 

The full texts are available under the following links:  
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_14_2017_INIT&from=EN
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_15_2017_INIT&from=EN