Notified Bodies under pressure and manufacturers engagement: the strategic role of Technical Documentation in medical device certification.

With the full application of Regulation (EU) 2017/745 (MDR), the entire medical device sector is facing a collective responsibility challenge. The Italian Ministry of Health, through a recent communication 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.

THE CURRENT SITUATION: A CERTIFICATION BOTTLENECK

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.

A CONCRETE ACCELERATION IS NECESSARY

As stated in the Ministry’s official note, no further extensions or amendments to the Regulation are expected. Therefore, the only way forward is operational collaboration and documentation efficiency. Notified Bodies – including ECM – have been urged to raise awareness among their clients: it is essential to promptly submit the required technical documentation to complete the conformity assessment procedures.

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

ECM’S ACTIVE ROLE AS A NOTIFIED BODY

As Notified Body No. 1282 under the MDR Regulation, ECM reaffirms its commitment to supporting manufacturers. Our goal is twofold:

• To provide manufacturers with procedural details, timelines, and relevant regulatory aspects through our Structured Dialogue service;
• To manage certification requests proactively, ensuring an efficient and professional assessment process.

Responsibility is shared, but the first step belongs to the manufacturers: to anticipate, prepare, and deliver all necessary documentation, enabling Notified Bodies to assess, certify, and – above all – ensure market continuity.

For more information on MDR certification procedures or any related inquiries, the ECM team is at your disposal. Contact us: Diego Stevanella diego.s@entecerma.it | Marzia Pellegrini marzia.p@entecerma.it