On 5 April 2017, the European Parliament adopted new regulations on medical devices and in vitro diagnostic medical devices. We are expecting them to be published in the Official Journal at the beginning of May, and 20 days following that they will enter into force. The transitional periods, 3 years for medical devices and 5 years for in vitro diagnostic medical devices, will start running then.
EU will require that all the products on the market be phased into the new system by the end of the transitional period. That means that you have to do a new conformity assessment under the new rules for all the devices currently on the market or remove the product from the market. There is no grandfathering, only a hard stop.
The new requirements are not limited to the product documentation but also affect your quality system, risk management, vigilance procedures and so on. One evident change is that the requirements for the clinical data will be much tighter. Additional clinical evidence may well be needed for your devices even if they have been on the market for years. If there is a need to perform clinical trials to gain the data, it is better to initiate actions well in advance.
It’s time to start to create a roadmap on how to comply with the new regulations. Medfiles medical device team is ready to assist you with this critical task! Please contact firstname.lastname@example.org.