Flaem Nuova S.p.A., as manufacturer of Flaem-branded medical devices, has over the past few years embarked on a demanding process of updating its product information materials in order to adapt to the entry into force of the new regulations for the medical sector: the MDR.
Flaem Nuova Spa is going through an extremely important and delicate period of regulatory change that affects everyone involved in the sector: the current Medical Device Directive 93/42/EEC (known as MDD) is being replaced by the new Medical Device Regulation (MDR) EU 745/2017, which introduces new requirements and new responsibilities for all Economic Operators involved.
The MDR Regulation was born out of the need to improve patient safety and renew legislation that was more than 25 years old, providing greater protection, transparency and safety for the end user.
On 30th January 2023, Flaem Nuova succeeded in obtaining the MDR Certificate from its Notified Body, becoming one of the first companies in the sector to have successfully completed this upgrade.
This is not a foregone conclusion, nor is it easy: it takes an average of 13/18 months, but Flaem Nuova has achieved it in less time thanks to its production quality, which has already been adapted to the new regulations. Nothing had to change in terms of safety levels and manufacturing quality: the company's efforts were focused on the requirements in terms of consumer information, from labelling to the design system, from the contents of the manuals to the preparation for future access to the EUDAMED (European Medical Device Database) system.
And this speed in adapting to new regulations demonstrates once again how Flaem's product quality has always been in step - if not one step ahead - of market requirements.