New EU Harmonized Standards Published: Six (6) Under MDR & Two (2) Under IVDR
10 April 2025
Swiss Federal Council Taking Steps to Allow US FDA Medical Devices in Switzerland
30 April 2025Team Notified Body (NB) has scheduled a second ½ day training session on MDR clinical requirements. The first session (occurring May 7, 2025) has already sold out.
The new training is scheduled for Wednesday, August 27, 2025.
Notably, the session starts at 1:30pm Central European Time. While this is still early in the Americas, it allows North and South American companies to more reasonably join the training.
The full overview is available: HERE
Who should join?
The training is intended for individuals who already have experience creating Clinical Evaluation Reports and/or involvement in the CE submission process, e.g., members of the manufacturer’s clinical team.
Therefore, the training will focus more on real case examples, and less on introduction to clinical requirements or citing regulations.
Training Logistics
The training is organized by Team NB, and the content was developed by BSI, CeCertiso, and Dekra
- The training time is 13:30 – 17:30 Central European Time (CET), i.e., optimal for individuals located in Europe and the Americas
- The training is limited to 50 organizations, with up to 2 separate connections per organization
- It will be conducted remotely, online
- Priority sign-up will be given to small-to-medium-sized enterprises (SMEs)
- Twenty-five (25) spots will be held for SMEs
- SMEs have until Monday June 30, 2025 to sign up for the reserved spots
- The fee is:
- EUR 550 per non-SME organization
- EUR 275 per SME organization
- The PDF in the above link contains the bank details for payment
- A Certificate of Attendance will be issued upon request
You can register for the training session: HERE
Training Agenda
NOTE: the first page of the Team NB Leaflet confirms the training starts at 13:30 CET. However, the second page outlining the agenda still shows an 8:30 CET start time. Therefore, we have taken the liberty to adjust the agenda based on a 13:30 CET start time.
- 13.30-13.45 – Welcome and Logistic Information
- 13.45-14.30 – Clinical Evaluation Routes
- In this session, we will explore the different clinical evaluation routes (Equivalence, Article 61.10, Clinical Investigation, Sufficient Clinical Evidence, etc) available to the manufacturers and discuss the common non-conformities identified by the NBs. By Ágnes Horvath (CE Certiso).
- 14.30-15.15 – How to build sufficient clinical evidence?
- In this session we will explore the interrelationship between SOTA [state of the art], benefit-risk analysis, and safety and performance criteria, and discuss the common non-conformities identified by the notified body during their assessment. By Nunung Nur Rahmah (Dekra NL).
- 15.15-15.30 – Break
- 15.30-16.15 – Post Market Surveillance and PMCF
- In this session, we will explore the interrelationship between PMS and Clinical Evaluation and discuss the common non-conformities identified by the notified body during their assessment of PMS plans, Periodic Safety Update Reports (PSUR) and PMCF plans and reports. By Breda Kearney (BSI).
- 16.15-17.00 – Q&A Session
- 17.00-17.30 – Closing Session
