The notification, that was published on the 20th of August in the European NANDO system, allows IMQ to support right now medical device manufacturers in getting certification under the new MDR Regulation.
The MDR – which will become mandatory as of the 26thof May and will replace the old Directives (93/42/EEC and 90/385/EEC) – is aimed to ensure high standards of quality and safety for medical devices, and therefore a high level of health and safety protection of patients and users. This is an important goal, also looking at the figures about a sector that only in Italy shows a production of 1.5 million devices per year, with a turnover of EUR 16.5 billion (import and export), 4.000 business companies and more than 76.000 employees (statistics by Confindustria for the year 2018).
The recent Regulation requires new and more stringent safety requirements by manufacturers, which are being checked through stricter conformity assessment procedures. The MDR also broadens its scope to a larger number of products by regulating non-medical devices such as color contact lenses for cosmetic purposes, injectable fillers, and aesthetic lasers.
It is interesting to note that the Regulation also introduced the use of a European Database for Medical Devices (EUDAMED), which is beneficial for a better market surveillance, ensuring full traceability and the chance to take action quickly in case of an accident.
During the process of approval for devices belonging to risk classes higher than Class I, following the earlier Directives, the MDR confirms the obligation for manufacturers to involve a NB such as IMQ. The independence of NBs is guaranteed by the notification system, which has become even more stringent, with continuous surveillance by the authorities.
The fact that IMQ is among the first four Notified Bodies in Europe that have been designated, confirms how much it promptly strove to develop and train its technical staff to carry out conformity assessment procedures, in accordance with the most stringent requirements of the new European Regulation.
“We have always played the tricky role as a Notified Body in several fields and we are really very proud to be the first Italian Notified Body for the new MDR European Regulation,” says Antonella Scaglia, President and CEO of IMQ. “The activity of NBs is essential to ensure that medical devices comply with safety and reliability requirements, for the benefit of the whole system and the players involved, from patients to doctors to healthcare professionals.”