New Medical Devices Regulation (MDR) Notified Body designation for Eurofins Product Testing Italy
On July 22nd , 2021, Eurofins Product Testing Italy Srl (No. 0477) became a Notified Body under the new Medical Devices Regulation (MDR).
Eurofins Product Testing Italy can now offer medical device manufacturers worldwide certification services according to Regulation (EU) 2017/745 for European market access covering an extensive range of medical devices1.
Since the May 26th 2021, new certificates in accordance with the current European Medical Devices Directives 93/42/EEC (MDD) & 90/385/EEC (AIMD) may no longer be issued. Medical devices currently covered by a valid certificate issued in accordance with these Directives can be placed on the European Market until May 26th 2024 and made available on the market or put into service until May 26th 2025.
If the device undergoes any significant changes in the design or intended purpose, as specified in the Art. 120, it is subject to certification according to the MDR as if it was a new product. Eurofins Product Testing Italy Srl identified and implemented the necessary processes to provide the continuity and quality of its services and support manufacturers to ensure uninterrupted European market access.
Alongside the MDR Notified Body certification services, Eurofins Product Testing Italy Srl provides a comprehensive suite of medical device solutions and can assist Customers in placing their medical devices onto the EU market in compliance with the most suitable certification procedures.
Eurofins Product Testing Italy Srl is a leader in the certification process for Medical Devices (Active and Non-Active), whenever the Notify Body assessment is mandatory for manufacturers, before commercialising the products and, in particular, for medical devices belonging to:
- Class I (measuring, sterile and reusable medical devices)
- Class IIa and IIb
- Class III
Eurofins Product Testing Italy Srl provides an extensive range of product testing and certification services and, as part of the wider Eurofins E&E group, can provide manufacturers, retailers and importers with the tools to deliver their products to global markets, quickly and cost-effectively.
Notes:
1 The scope of designation for Eurofins Product Testing Italy is available online, on the NANDO website (New Approach Notified and Designated Organisations), the European Commission's information system.
