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.
Reprocessing represented one of the most contentious points during the negotiations with some stakeholders strongly in favour of allowing reprocessing by default while others were strongly against such activities without the consent of the individual Member States.
Reprocessing refers to enabling a device to be safely reused through cleaning, disinfection, sterilisation and related procedures, including testing and restoration of the technical and functional safety of the previously used device.
According to the text of the new Regulations, reprocessing of devices will only be permitted in accordance with individual Member State legislation which may prohibit such reprocessing. The Commission is tasked with drawing up a report within four years after the date of application of the Regulations on the operation of these provisions and submit it to the European Parliament and to the Council for consideration.
The Regulations will further tighten the rules for the independent bodies that are...