The European Commission (Q&A, Revision 2, July 2024) has indeed confirmed a crucial point: if a medical device manufacturer terminates the relationship with a Notified Body and simultaneously transfers the application to another body (also designated under the MDR), the conditions for accessing the transitional period remain valid.
What does this mean in practical terms? It means you can benefit from greater operational capacity or a more agile service by choosing a different partner than your initial one, without losing the advantages of the transition.
THE SUPPORT OF ECM
We are pleased to announce that Ente Certificazione Macchine has joined the Normec Group.
Thanks to this operation, we are growing rapidly and expanding our technical staff. This allows us to offer even greater responsiveness and flexibility in supporting manufacturers through the challenges of MDR certification.
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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25 Jun 2026
UPDATED LIST OF IMPROPER USES OF THE NAME ENTE CERTIFICAZIONE MACCHINE SRL AND/OR THE ECM NUMBER OF NOTIFIED BODY 1282
To consult the updated list of reports of misuse of the name Ente Certificazione Macchine srl and/or the notified body number 1282, click here.
22 Jun 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA): Gianluca Baldoni – Internationalization of the regional production system (Emilia-Romagna Region)
As part of the signing of the Memorandum of Understanding (MoU) on May 15, 2026, between ECM – Ente Certificazione Macchine and KoTHEA (Korea Total Healthcare Ecosystem Association), we continue to gather testimonials from the institutions and key partners supporting this important strategic bridge between Italy and South Korea. Today we feature the contribution of Dr. Gianluca Baldoni (Internationalization of the Regional Production System – Attractiveness, Internationalization, and Research Sector; Export and Trade Fair System Area of the Emilia-Romagna Region), who participated in the institutional event held in the presence of local authorities and the Consul General of the Republic of Korea in Milan.
19 Jun 2026
EUDAMED: The Regulatory Turning Point for Medical Devices
May 28, 2026, marked a watershed moment for medical devices in Europe. As of this date, full EUDAMED registration became mandatory for all devices undergoing certification under the MDR and IVDR regulations. The database becomes the operational hub of the single market. This is not a bureaucratic formality, but a binding requirement to maintain market access.
19 Jun 2026
The voices of the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KoTHEA): Choi Taeho – Consul General of the Republic of Korea
International ties and strategic development prospects are strengthening around the crucial Memorandum of Understanding (MoU) signed at the Valsamoggia headquarters between the Korea Total Healthcare Ecosystem Association (KoTHEA) and the European notified body Ente Certificazione Macchine (ECM). The official ceremony was graced by the prestigious participation and institutional support of Choi Taeho, Consul General of the Republic of Korea, who emphasized the high political and economic value of this agreement. The agreement represents not only a technical milestone but also a genuine turning point in industrial and regulatory relations along the Seoul-Rome axis, fitting into a rapidly evolving global macroeconomic framework.
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New Machinery Regulation, the entry into force approaches: what’s new for Manufacturers
The European regulatory landscape is undergoing a crucial transformation with the introduction of Regulation (EU) 2023/1230, which will permanently phase out the historic Machinery Directive 2006/42/EC. One of the most impactful changes concerns the obligation to integrate cybersecurity as an essential element of product safety.
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IMPORTANT NOTICE: Immediate suspension of the use of the product “Hyperbaric chamber”
We would like to inform all our valued customers and business partners of an urgent measure that requires the utmost attention and timely cooperation from all users.
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Hedge Trimmer Compliance: EMC and Vibration Testing
ECM remains committed to supporting manufacturers of garden equipment, with a strong focus on the safety and technical compliance of hedge trimmers. In an increasingly demanding market, ensuring that these tools meet the requirements of the Machinery Directive and the EMC Directive is essential to protect operators and guarantee the free movement of products within the European market.