UK MHRA Publishes Response to Fee Increase Consultation: What is Changing and When
11 March 2025
MDCG 2020-16 Rev. 4: IVDR Classification Guidance Updated, COVID-19 Tests Down Classified
18 March 2025Team Notified Body (NB) is offering a ½ day training session on MDR clinical requirements. It is scheduled for Wednesday May 7, 2025. 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 Details
The training is organized by Team NB, and the content was developed by BSI, CeCertiso, and Dekra
- The training time is 8:30 – 12:30 Central European Time, i.e., optimal for individuals located in the EU and Asia Pacific
- 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 Friday April 11, 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
- 8.30-8.45 – Welcome and Logistic Information
- 8.45-9.30 – 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).
- 9.30-10.15 – 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).
- 10.15-10.30 – Break
- 10.30-11.15 – 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).
- 11.15-12.00 – Q&A Session
- 12.00-12.30 – Closing Session
