Team-NB Publishes Report on MDR Technical Documentation Training

Team-NB, the European association of Notified Bodies for medical devices, has released the results of its eighth training session dedicated to the technical documentation required by the European Medical Devices Regulation (MDR) 2017/745. The main aim of this initiative is to help manufacturers - especially small and medium-sized enterprises (SMEs) - understand and comply with the strict requirements of the MDR, reducing the challenges of submitting documentation for certification.

Training Highlights

The session, organized in collaboration with 11 Notified Bodies (including BSI, CeCert, Dekra B.V., DNV, ECM, GMED, NSAI, SGS, TÜV Rheinland and TÜV SÜD), focused on the following topics:
✔ Detailed interpretation of technical documentation requirements in the context of the MDR.
Best practices for submitting documentation to Notified Bodies.
Main challenges faced by companies in implementing regulatory requirements.
Interactive Q&A sessions, with clarifications from industry experts.

Program Impact and Results

The training was attended by 95 professionals from 54 organizations, more than 50% of which were SMEs, who benefited from a reduced price incentive to encourage them to join. In the last 14 months, Team-NB has already organized 8 training sessions, covering a total of 625 professionals from 353 companies.

The results show that:
🔹 Large manufacturers have already submitted at least one technical dossier, while only 50% of SMEs have completed this process.
54% of large companies have updated half or more of their technical documentation, compared to only 36% of SMEs.
🔹 This data shows that SMEs continue to face difficulties in adapting to the MDR, and more support is essential to ensure regulatory compliance.

Compliance with the MDR remains a challenge for many companies, and initiatives such as these are essential to ensure the correct implementation of regulatory requirements, minimize delays in certification processes and avoid risks of non-compliance.

Access the full report below.