MDR compliance: ECM issues new EU certificates

2 July 2024

ECM continues to demonstrate its commitment to the safety and compliance of medical devices by issuing new EU certificates under Regulation 2017/745 (MDR).

We are excited to announce that the ECM Medical Devices Division team continues to work at full capacity to issue new certificates compliant with Regulation (EU) 2017/745 (MDR). As Notified Body No. 1282, we carry forward our mission to provide manufacturers with professional and reliable services for the conformity assessment of medical devices.

The issuance of new certificates under Regulation (EU) 2017/745 (MDR) represents a crucial step for the medical device market, preventing potential shortages in the EU market and ensuring the marketing of safe and compliant products.

As European Notified Body No. 1282, we have consolidated our international prestige, by offering cutting-edge services to meet the challenges of the ever-evolving regulatory landscape. By actively participating in European institutional meetings and intervening at major regulatory events with stakeholders, we stay updated on the latest regulatory issues.

Thanks to a team of experts always on the ball, we can ensure a thorough and constant commitment to the process of verifying the compliance of medical devices.

Following the expiration of the deadline to take advantage of the extended transition period for legacy devices, it is essential that manufacturers promptly begin the MDR certification process. Methodically planning activities and submitting the required technical documentation to your notified body on time are crucial steps to ensure an efficient certification process.

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

Diego Stevanella – Sales Manager ECM

ECM is ready to accept new certification applications to verify the safety and compliance of your medical devices!