14 July 2021

Kiwa Cermet Italia achieves notification to the Medical Device Regulation (MDR)

Kiwa Cermet Italia has successfully achieved designation as a Notified Body by the Italian Ministry of Health and the European Commission for Conformity Assessment activities according to the Medical Devices Regulation 2017/745/EU.

As Kiwa, we are very proud to obtain this recognition after a long and challenging process started in September 2018.Thanks to the investments made by Kiwa Italia Group in addition to the great commitment and involvement of all the staff, we were able to obtain the MDR designation with almost full scope, ensuring continuity of medical services to all our customers.

In the next future, Kiwa intends to continue its international expansion as well as the increase of medical portfolio services, such as UKCA mark and MDSAP, with the aim to guarantee the global markets access and to provide a quality service supporting all companies in the medical sector.

As of today, Kiwa Cermet Italia is able to deliver services related to CE mark for a wide range of medical devices, including also the highest risk class III, the device including medicinal products and the imaging device utilizing radiation, ensuring not only the continuity of EU market access for our customers, but also the increase of service portfolio compared to the actual MDD designation.

The Medical Devices Regulation

The Medical Devices Regulation (2017/745/EU) published in May 2017 replaced the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices directive (90/385/EEC). After the transitional period, the full application of the MDR took effect on May 26th, 2021.

For medical device manufacturers the MDR is their number one concern, because they have to change many things to comply to this legislation. But also, for Notified Bodies (NBs) a lot of changes regarding their role and responsibility take place.

Key changes in MDR

The MDR differs significantly from the MDD, it contains a series of new requirements and key changes. According to the EU the new legislation brings a lot of improvements to conformity assessment for medical devices with the intention to:

  • Improve the quality, safety and reliability with tighter controls on medical devices and their related clinical evidences;
  • Strengthen transparency of information related to medical devices for consumers;
  • Enhance post market activities and traceability of medical device. 

Read more about the new regulations on medical devices on the EU website.