Notified bodies under pressure and manufacturers: The strategic role of technical documentation in MDR certification for medical devices.

THE CURRENT SITUATION: A BOTTLENECK IN CERTIFICATIONS

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 NEEDED

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 for the MDR Regulation, ECM reaffirms its commitment alongside manufacturers. Our goal is twofold:

• Providing manufacturers with procedural details, timelines, and relevant regulatory requirements 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