The Italian Ministry of Health has designated Ente Certificazione Macchine Srl as new Notified Body for the MDR Regulation (EU) 2017/745.

Ente Certificazione Macchine Srl is Notified Body no. 1282 for the new European Regulation for Medical Devices (MDR), designated by the Italian Ministry of Health, with publication of the notification on the European Commission’s NANDO portal on 14 October 2022.

“The designation of ECM is a great milestone for our company,” says the ECM Sole Administrator Luca Bedonni, “a special thanks goes to all our staff, who worked hard to carry out a complex accreditation process, performing in parallel the certification activities according to the MDD, non-stop, even during the most difficult period of the pandemic.”

THE REGULATION (EU) 2017/745

Regulation (EU) 2017/745 (MDR), which replaces Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD), applies to all manufacturers wishing to place their medical devices on the European Union market from 26 May 2021.

The MDR imposes strong compliance requirements to ensure high standards of quality and safety, including:

• Stricter and more precise requirements regarding technical documentation and clinical assessments and investigations;
• Increased post-market surveillance and follow-up obligations;
• New traceability and registration rules for medical devices.

From 27 May 2024, Regulation (EU) 2017/745 will be fully applicable to all medical devices, which will have to be certified according to the MDR in order to be placed on the EU market.

ECM’S EXPERTISE

Since 2017, Ente Certificazione Macchine has been Notified Body No. 1282 for the Medical Device Directive 93/42/EEC (MDD) and an accredited body for the certification of Quality Management Systems to the international standard EN ISO 13485:2016.

ECM is also an active member of Team-NB – the European Association of Notified Bodies for Medical Devices – and participates in the periodic coordination meetings of European Notified Bodies, bringing its experience and expertise in regulatory matters.

As of today, Ente Certificazione Macchine is able to provide manufacturers with the conformity assessment service for medical devices under Regulation (EU) 2017/745, for which ECM operates as Notified Body No. 1282. The list of devices that fall under the scope of ECM is available on the NANDO portal.

Considering the current number of Notified Bodies compared to the number of certificates that will expire in 2024, it is essential for companies to promptly comply with the requirements of the MDR and contact a Notified Body to assess their compliance well in advance of the end of the transition period.

“We are ready and excited to start the MDR conformity assessment activities and we invite all manufacturers to contact us as soon as possible, in order to ensure that devices can continue to be placed on the market and avoid shortages of medical devices” Bedonni concludes.

For information on CME services for medical devices:

SALES MANAGER ECM – Eng. Diego Stevanella diego.s@entecerma.it | mob. (+39) 393 2471040

Download the official press release >>