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.

THERE IS A NEED TO HURRY

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.

THE ACTIVE ROLE OF ECM AS A NOTIFIED BODY

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

• To provide manufacturers with procedural details, timelines, and relevant regulatory aspects related to the certification process through the Structured Dialogue service;
• Proactively managing certification requests through 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 information on MDR certification procedures and to request a quote, the ECM team is at your disposal.

Contact us at: Diego Stevanella diego.s@entecerma.it | Marzia Pellegrini marzia.p@entecerma.it