About us
ECM – Ente Certificazione Macchine, founded in 1998 in Italy, has grown into an internationally recognized certification and testing organization. From its headquarters in Valsamoggia (Bologna), ECM supports manufacturers worldwide through an extensive network of commercial partners in Europe, Asia, the Middle East, and the United States. Over the years, the organization has continuously expanded its expertise and has become a Notified Body for multiple European product directives, an accredited testing laboratory, and a National Certification Body (NCB) within the international IECEE CB Scheme.
To support the rapid growth of its Medical Devices division, ECM opened a dedicated facility in 2020 featuring a comprehensive testing laboratory equipped with advanced technologies, including a state-of-the-art semi-anechoic chamber. In 2022, following a thorough evaluation by the relevant national and international authorities, ECM was designated as a Notified Body under the European Medical Device Regulation (MDR) 2017/745, thereby further strengthening its position as a trusted partner for certification, testing, and regulatory compliance.
Contact us
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Via Cà Bella 243, 40053 Valsamoggia, Castello di Serravalle (BO), Italy
+39 051 6705141
info@entecerma.it
Services
Explore our services and discover how we can support you. With a wide range of solutions, we help you address a variety of challenges, tailored to your organization.
Notifications and Accreditations
Ente Certificazione Macchine is an independent certification, inspection, testing, and training body. Over the years, ECM has expanded its areas of expertise and the range of services it offers by obtaining accreditations and notifications. The accreditations as a notified body were issued by Accredia, and those as a testing laboratory were issued by Perry Johnson Laboratory Accreditation Inc. (PJLA). Accredia, as the sole national accreditation body designated by the Italian government—that is, the only body recognized in Italy to certify that certification and inspection bodies possess the competence to assess the compliance of products, processes, and systems with the relevant standards—operates under the supervision of the Ministry of Enterprises and Made in Italy (MIMIT). Visit the website www.accredia.it
White Papers
Requests for Information, Complaints, Objections, and Reservations
To request information, supplementary materials, quotes, and specific procedures for each guideline, please fill out the form below by entering the required information.
ECM’s procedure for handling complaints, reports, objections, and reservations varies by service. This procedure is described in specific regulations that contain all information regarding the handling process, the rules, and the instructions for submitting complaints to ECM, specifically:
- Services related to “QMS Certification – UNI EN ISO 9001, UNI CEI EN ISO 13485 Regulations,” see the“SG_14 Regulations for the Certification of Quality Management Systems, Chapter 7.14”
- Services in the field of “Certification of Medical Devices – MDD, MDR Regulations,” see:“Regulations for Existing Medical Devices (MDD) (QA_12), Chapter 10” and“Regulations for the Certification of Medical Devices (RG_MDR), Chapter 22”
- “Inspection Services – ISO/IEC 17020 Scheme, DLG 81-2008,” see the“Inspection Regulation DLG 81-2008 (RTVP), Chapter 6.5”
- Services in the field of “Product Certification – Regulation 17065,” see the“Regulation on Product Certification (RGPRD), Chapter 13”
- Services in the field of “Voluntary Product Certification,” see the“Regulation on Voluntary Non-Notified Certification, Chapter 14.”
News
Normec is leading the way. Stay informed.
27 May 2026
ECM expands its horizons: launching certification and testing services according to SEMI standards
Ente Certificazione Macchine (ECM) officially joining SEMI, the global microelectronics association, marks the beginning of a new operational phase. The Body announces the expansion of its services to the industry’s rigorous standards: ECM will carry out testing and certification activities according to SEMI guidelines, becoming a strategic reference point for machinery manufacturers targeting the semiconductor supply chain.
28 May 2026
The ECM report on SPS Italia 2026: the exhibition for smart, digital, and flexible industry
The 2026 edition of SPS Italia was not only a showcase for commercial success and high-profile networking; it left us with the awareness of having experienced a true breakthrough moment. We are facing a crucial paradigm shift, where compliance is no longer a mere bureaucratic obligation, but the real driver of innovation.
03 Jun 2026
Towards the new Machinery Regulation: ECM participates in the European meeting of Notified Bodies
ECM’s commitment to actively contributing to the regulatory dialogue on machinery continues through its participation in the European coordination meeting of Notified Bodies. In June, Ente Certificazione Macchine will take part in a major European institutional meeting organized at an international level dedicated to the machinery sector, which will bring together Notified Bodies for a direct dialogue with the institutions.
27 May 2026
Ente Certificazione Macchine (ECM) officially joins SEMI: a bridge to the future of semiconductors
A major new chapter begins for Ente Certificazione Macchine. With great pride, ECM announces its official entry into SEMI, the leading global association that brings together over 4,000 leading companies in the microelectronics and semiconductor supply chain. This strategic move projects the organization into the heart of one of the most dynamic and technologically advanced sectors of the global market.
27 May 2026
CE marking process, EMC and LVD testing, Accredited laboratory: bring your products worldwide with ECM
Bringing a new product to market requires speed and certainty. That is why Ente Certificazione Macchine (ECM) has created a streamlined and concrete ecosystem of services, specifically designed for SMEs looking to accelerate their compliance processes without wasting time.
11 Jun 2026
ECM in Palermo for the 61st CNB-MA Meeting: towards an increasingly harmonized European regulatory framework
ECM confirms its institutional commitment within the European technical committees of Notified Bodies, contributing to the evolution of the regulatory framework for machinery. An important European institutional appointment has concluded, which ECM took part in, confirming its commitment to active participation in the coordination committees among Notified Bodies. Our Press Office & Social Media Manager Luca Serra represented ECM in Palermo on the occasion of the 61st CNB-MA HC Meeting (June 9-10, 2026) dedicated to the Machinery Regulation 2023/1230.
We are part of the Normec Group.
Normec is a leading organization in the TICC sector (Testing, Inspection, Certification, Compliance). Our areas of expertise range from (drinking) water quality, air quality, and soil quality to fire safety, food safety, management systems, fair labor practices, good working conditions, and social compliance. Every day, we work to create a safe, healthy, and reliable work and living environment—for current and future generations.
Downloads & Links
- WEB0031 NOTE LEGALI facoltativo
- QAT02 M08 REV 07 Mission Politica Obiettivi Qualita Dich Autorita IT
- All 2 Codice Etico
- 2025 02 MOG ECM Documento di sintesi per sito
- QAT08 M00 REV 06 Dichiarazione Direzione Indipendenza Imparzialita Riservatezza
- Elenco Documenti Falsi 2026 06 30
- Pdf uso improprio rev 2026 06 25