As highlighted by the latest Team-NB survey, the timely update and submission of technical documentation are essential steps for efficiently navigating the MDR certification process.

The transition to Regulation (EU) 2017/745 (MDR) is a complex challenge for medical device manufacturers, who must update and submit their technical documentation to the Notified Body to obtain certification. To assess the progress of this process, Team-NB conducted a survey among manufacturers attending the February Technical Documentation Training session.

STATUS OF TECHNICAL DOCUMENTATION

The survey involved 95 professionals from 54 different organizations, with a significant participation of SMEs. Participants were asked for feedback to assess the effectiveness of the training and understand their progress in the MDR transition, thus highlighting the level of manufacturers’ preparedness in reviewing and submitting their Technical Documentation for certification.

The results show that:

• All large manufacturers have submitted at least one technical file to their Notified Body, whereas only 50% of SMEs have done the same;
• 54% of large manufacturers have updated at least half of their Technical Documentation, compared to 36% of SMEs.

RISKS OF DELAYS IN CERTIFICATION

These findings indicate that significant efforts are still needed to ensure that technical files are submitted to Notified Bodies for certification. Given that the MDR certification process takes longer than in the past, current delays in documentation updates and postponed submissions could lead to a bottleneck within 2 years, despite the extension granted by Regulation (EU) 2023/607.

As Notified Body No. 1282, ECM also observes that delaying the submission of technical files could place both manufacturers and Notified Bodies in a critical situation in the near future. If documentation is only submitted in the last available months before the deadline, Notified Bodies may struggle to manage the high volume of reviews, with a consequent lengthening of certification timelines and potential disruptions in the marketing continuity of devices.

ACT NOW TO AVOID CRITICAL ISSUES

To ensure an efficient certification process without delays, it is crucial for manufacturers to act promptly by updating and submitting their technical documentation to the Notified Body in time for the necessary conformity assessments.

To support manufacturers in the MDR transition, Team-NB has developed specific training programs, including the MDR Technical Documentation Training. This course is designed and delivered by medical device experts from 11 Notified Bodies, including ECM, with the aim of providing manufacturers with clear guidance on regulatory requirements, useful for drafting technical documentation that complies with MDR standards.

The next Team-NB course on MDR Technical Documentation is scheduled for June 17, while a half-day training session focused exclusively on clinical aspects will be held on May 7. Don’t miss these opportunities to deepen your knowledge of MDR requirements and navigate the certification process more effectively!

Contact our Notified Body to start a structured dialogue or begin your MDR certification process!

Diego Stevanella – diego.s@entecerma.it

Marzia Pellegrini – marzia.p@entecerma.it