Achievements
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1.
Safe import check: an important service for your shipments
Our Safe Import Check service verifies, through pre-shipment inspections and assistance during customs checks, that imported goods comply with the standards required for entry into the EU market. Furthermore, thanks to the opening of the Ente Cerma Certification Shanghai branch, ECM is able to offer a comprehensive solution for Italian and European companies importing from China, managing the entire control and inspection process to prevent the risk of receiving non-compliant, counterfeit, or damaged goods.
Despite the turbulence in global markets, over the course of 2025, more and more companies have adopted this type of service to ensure a smooth and secure process, thanks to our many years of experience in the sector.
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2.
Consolidation of international partnerships
In 2025, ECM was engaged on several fronts to strengthen our presence in international markets. We had the pleasure of hosting a delegation of three key South Korean players, recognized leaders in the medical innovation landscape. The meeting, held at our headquarters, focused on building a solid and strategic partnership.
We then enthusiastically met with customers and collaborators from the medical sector at MEDICA 2025, an unmissable event for the major international players in the sector.
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3.
Expansion of the machinery certification body team
Our team has expanded with the arrival of Luca Serra, a new Press Office & Social Media Manager to strengthen our communications, and Damiano Pignalosa, a Sales Manager & Business Developer, for strategic expansion into the national market.
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4.
Growth in the medical sector and continuing education
ECM continued to support the medical industry as a Notified Body for Regulation (EU) 2017/745 (MDR), through its EU certification activities and by participating as a speaker at key national and international events, including the “EU Regulations Discussion Day 2025” organized by Team-NB, the “Medical Devices Regulation: state of the art of the Medical Devices and Healthcare sector” organized by Confindustria Emilia Area Centro, and the “Regulatory Affairs Day 2025” organized by Confindustria DM. Participation in these initiatives, together with our structured dialogue service, strengthens our role as a strategic partner for manufacturers, demonstrating our commitment to improving the efficiency of conformity assessment processes.
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5.
More and more ECM customers have reached the MDR 2017/745 compliance milestone
This significant achievement, the fruit of preparation, technical expertise, and strategy, confirms Ente Certificazione Macchine’s commitment to supporting medical sector companies on the path to full compliance with Regulation (EU) 2017/745 on medical devices.
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6.
Goals for 2026
Our Test Laboratory will be equipped with new equipment, allowing us to meet increasingly advanced testing needs.
Furthermore, thanks to the dedication of our team and the trust of our partners, we will continue to consolidate our leadership position in the certification and testing landscape, looking to the future with new goals.
We close out the year with a special thank you to our staff, collaborators, and customers for their continued support and trust in our business. ECM wishes you a prosperous 2026!
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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30 Jun 2026
UPDATED THE LIST OF FAKE/FORGED DOCUMENTS
ECM – Ente Certificazione Macchine is informed of the existence of fakes/counterfeit certificates/laboratory test reports/other ECM documents relating to certain European Directives or International Standards. No one has permission to issue certificates or other documents in our name and on our behalf, so ECM will take action against any companies that issue certificates/documents without authorization.
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.
18 Jun 2026
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.
18 Jun 2026
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.