Initiated against the backdrop of the well-documented PIP breast implant issues, the new Regulations have been the subject of rigorous scrutiny and comment for the past four years. On 14 June 2016, the agreed texts of the Regulations were finally published on the Parliament’s website which brings us closer to, arguably, the biggest legislative overhaul in the history of the medical device industry.
Further to our previous alert on this issue, below are some of the key elements of the new Regulations on medical devices and in vitro medical devices.
Definition of medical devices expanded
The definition of medical devices is expanded to include, amongst others, devices with purposes related to prediction and prognosis of diseases. This will have a significant impact on quantification products and services in the field of health-related parameters which could now fall within the scope of the new Regulations. Companies operating in the mHealth sector would also be advised to bear in mind any potential impact the draft European Commission guidelines on mHealth may have on their products.
The Regulations will also apply to a group of products without an intended medical purpose that are listed in Annex XV, such as contact lens, equipment for liposuction and products used for tattooing. These products will have to meet common specifications that address risk management and, where necessary, clinical evaluations regarding safety.