{"id":9581,"date":"2025-06-06T12:44:20","date_gmt":"2025-06-06T10:44:20","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-certification-its-time-to-accelerate-technical-documentation\/"},"modified":"2025-06-06T12:49:15","modified_gmt":"2025-06-06T10:49:15","slug":"mdr-certification-its-time-to-accelerate-technical-documentation","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-certification-its-time-to-accelerate-technical-documentation\/","title":{"rendered":"MDR Certification: it\u2019s time to accelerate technical documentation"},"content":{"rendered":"\n

Notified Bodies under pressure and manufacturers engagement: the strategic role of Technical Documentation in medical device certification.<\/em><\/strong><\/h2>\n\n

With the full application of Regulation (EU) 2017\/745<\/a> (MDR)<\/strong>, the entire medical device sector is facing a collective responsibility challenge. The Italian Ministry of Health<\/em><\/strong>, through a recent communication<\/a> addressed to Notified Bodies and major industry associations, has sent a clear message: an immediate effort is required from manufacturers to complete and submit the technical documentation needed for conformity assessment<\/strong>.<\/p>\n\n

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THE CURRENT SITUATION: A CERTIFICATION BOTTLENECK<\/strong><\/h3>\n\n

While certification requests and contracts signed with Notified Bodies are significantly increasing, the number of MDR certificates actually issued is not keeping pace. This imbalance risks creating a critical situation: delays in placing devices on the market and significant impacts on the entire European healthcare system.<\/p>\n\n

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A CONCRETE ACCELERATION IS NECESSARY<\/strong><\/h3>\n\n

As stated in the Ministry\u2019s official note<\/a>, no further extensions or amendments to the Regulation are expected. Therefore, the only way forward is operational collaboration and documentation efficiency<\/strong>. Notified Bodies \u2013 including ECM \u2013 have been urged to raise awareness among their clients: it is essential to promptly submit the required technical documentation<\/strong> to complete the conformity assessment procedures.<\/p>\n\n

Manufacturers who fail to act in time risk losing access to the European market. This risk goes beyond business competitiveness \u2013 it directly affects continuity of care, patient safety, and the sustainability of the healthcare system.<\/p>\n\n

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ECM\u2019S ACTIVE ROLE AS A NOTIFIED BODY<\/strong><\/h3>\n\n

As Notified Body No. 1282<\/strong><\/a> under the MDR Regulation, ECM reaffirms its commitment to supporting manufacturers. Our goal is twofold:<\/p>\n\n