Ente Certificazione Macchine reflects on the outcomes of the 70th coordination meeting of notified bodies for medical devices to discuss challenges and strategies related to certification under MDR regulation.

Ente Certificazione Macchine recently participated in the 70th NBCG-Med Meeting. In Brussels, representatives of EU Notified Bodies, EU Commission, and major stakeholders addressed crucial topics defining the current landscape of medical device certification in Europe.

KEY ISSUES

During the meeting, extensive discussions took place regarding the extension of the transitional period and the capacity of Notified Bodies to handle manufacturers’ certification requests. This discussion highlighted the need for concerted actions to ensure a smooth transition to the new regulatory regime, while also pointing out a complex framework in which NBs face several challenges in managing certification requests.

EMERGING CHALLENGES

The debate identified key situations influencing the medical device certification process.

1. Delays in the submission of documentation by manufacturers: all notified bodies emphasized that manufacturers often tend to delay or miss deadlines for submitting the necessary documentation. This approach actually makes it difficult for NBs to plan and manage the certification process efficiently and promptly.
2. Revision of MDCG Guidelines: several MDCG guidelines are currently under review, essential for guiding manufacturers and NBs in the certification process, which could bring greater clarity and transparency to compliance requirements.
3. Potential establishment of structured dialogues: discussion around the possibility of establishing structured dialogues between NBs and manufacturers to enhance the certification process, although this still requires further insights and concrete indications for implementation.

ECM CALLS TO ACTION

In conclusion, the 70th NBCG-Med Meeting highlighted the regulatory challenges in the medical device certification sector. Ente Certificazione Macchine – Notified Body 1282, invites manufacturers to meet deadlines and not delay the various steps of the certification process, from submitting the application to the delivery of relevant documentation. We are also available to initiate a structured dialogue around their specific case, aiming to foster an efficient and professional certification process.

This commitment reflects ECM’s continuous dedication to verifying the safety and compliance of medical devices according to the European standards. Please do not hesitate to contact our Sales Manager Diego Stevanella to learn more about our services at diego.s@entecerma.it | cell (+39) 393 2471040.