ECM issues new certificates under the EU Medical Device Regulation

6 February 2024

We are excited to announce the issuance of another certificate in accordance with Regulation (EU) 2017/745 (MDR).

In line with our mission to ensure professional and reliable medical device conformity assessment services for manufacturers, ECM issues another certificate under MDR 2017/745. This further step highlights our ongoing commitment to excellence and quality services for medtech companies.

As European Notified Body No. 1282, we have consolidated our international reputation, ensuring that our services remain at the forefront to meet evolving regulatory challenges. This requires ongoing updates, active participation in European institutional meetings, and engagement with stakeholders on key regulatory focuses.

We proudly affirm that our team of experts possesses the skills and experience necessary to ensure a thorough and constant commitment to the medical device conformity verification process.

Within the next 4 months, thousands of MDD certificates will expire. To extend their validity, it is essential for manufacturers to formally apply for certification with a Notified Body under the Medical Device Regulation (MDR) by 26 May 2024.

Considering the longer timelines of the MDR certification process and the significant increase in requests, Notified Bodies are quickly approaching their maximum capacity for new customers. Therefore, manufacturers must act promptly to ensure certification applications are processed as soon as possible.

The ECM team is ready to welcome new certification applications! The issuance of new MDR certificates marks a significant stride in our mission to assess medical devices destined for the EU market. This initiative is crucial to prevent shortages of medical devices in the EU market and to verify their safety and compliance.

Contact us today to start the certification process of your medical device at:

Diego Stevanella – Sales Manager ECM