Team NB Position Paper: Proposal to Reclassify SARS-CoV-2 (COVID) in vitro Diagnostic Devices
22 February 2024
New EU MDR/IVDR Harmonized Standards Published
11 March 2024Table of Contents
Summary
Team Notified Body has announced a 6th MDR training session. The 5th session for April 2024 is fully booked. The details are available: HERE
Team Notified Body is presenting in a webinar titled “The Notified Body Role & The Conformity Assessment Process”. It is free to attend. The details are available: HERE
MDR Training: Wednesday 12 June 2024
The details are:
- The training is organized by Team NB, and the content was developed by BSI, CeCertiso, Dekra, DNV, ECM, GMED, SGS, TÜV Rheinland, and TÜV SÜD.
- The training time is 9:00 – 17:00 Central European Time.
- i.e., optimal for EU-based individuals.
- The training is limited to 50 organizations.
- It is conducted virtually, with up to 2 separate connections per organization.
- Priority sign-up will be given to small-to-medium-sized enterprises (SME).
- Twenty-five (25) spots will be held for SMEs.
- SMEs have until Wednesday 8 May 2024 to sign up for the reserved spots.
- The fee is:
- EUR 450 per SME
- EUR 900 per non-SME organisation
- A training attendance certificate will be issued upon request.
You can register for the training session: HERE
Training Agenda
- 9.00 to 9.30 – Welcome and logistic information
- 9.30 to 10.15 – Structure of Technical Documentation
- Focus on documents/information commonly missing or unclear
- 10.30-12.00 – MDR Annex II Sections 1-3
- Common nonconformities: device description and specification, information to be supplied by the manufacturer (i.e., labeling), design and manufacturing information
- 13.15 to 14.45 – MDR Annex II Sections 4
- Common nonconformities: GSPRs, benefit-risk and risk management, pre-clinical data
- 15.00-16.30 – MDR Annex II Section 6 (clinical data) and Annex III (post-market surveillance)
- Common nonconformities
- 16.30-17.00 – Closing session
- Last questions, feedback, and suggestions
There will be multiple opportunities for Q&A throughout.
Webinar: Monday 25 March 2024
The titled “The Notified Body Role & The Conformity Assessment Process” webinar will take place on Monday 25 March 2024, at 11:00am US Central Time/17:00 EU Central Time. It will last 1.15 hours, and attendance is free.
The agenda is:
- 17.00 – 17.05: Introduction: Alan Fraser
- 17.05 – 17.20: The Notified Body Conformity Assessment Process. Richard Holborow, BSI Group 17.20 – 17.35: The Challenge of MDR implementation: A Notified Body Perspective. Suzanne Halliday, BSI Group
- 17.35 – 17.50: Moving forward – How will the work of Core MD support Notified Bodies? Françoise Schlemmer, Team NB
- 17:50 – 18:15: Question and answers with the audience
You can register for the webinar: HERE
