Structured Dialogue with ECM - Notified Body No. 1282

Ente Certificazione Macchine Srl

Valsamoggia (BO), Italy

Ente Certificazione Macchine is EU Notified Body No. 1282 for Medical Device Regulation (UE) 2017/745. With a long experience in the certification of products, machinery and medical devices, Ente Certificazione Macchine srl (ECM) provides certification and testing services to a wide range of international companies. ABOUT ECM - MEDICAL DEVICES DIVISION Since 2017, ECM is a valuable partner for companies in the field of medical devices needing certification according to Directive 93/42/CE (MDD). Since 2022, ECM is designated by the Italian Ministry of Health as Notified Body also for Regulation (EU) 2017/745 (MDR) . Boasting a team of highly qualified experts in testing, conformity assessment, and auditing, Ente Certificazione Macchine, operating as Notified Body No. 1282, provides medical device manufacturers with a conformity assessment service for EU certification according to MDR. Within the scope of this process, ECM also engages in structured dialogues with manufacturers, to clarify, procedural details, timelines, and regulatory aspects relevant to the certification process. In addition, ECM can provide the following services in the field of medical devices: Quality Management System certification according to ISO 13485 standard Testing services as an ISO 17025 accredited Testing Laboratory.