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Evaluation ViewAttendees 10

Preconference Workshop

Devices (includes Medical Devices and In Vitro Diagnostics)

IVDR Technical Documentation Pre-conference Workshop

Tuesday, October 3, 2023
8:30 AM – 4:00 PM EDT
Location/Room: 511F
Additional Registration Fee Advanced Level
The assessment of the Technical Documentation (TD) is a central part of the conformity assessment and currently many deficiencies are identified during the assessment of TD files. Some of the deficiencies reflect the lack of consideration of requirements that impact all aspects of TD e.g. risk management documentation being out of date and make the approval of the TD very difficult. This is a particular problem for round one files/queries/deficiencies.
The aim of this workshop is to review NB expectations; it is also planned to review the Team NB TD Best Practice document for IVDR published 01 March 2023.
A successful transition to the IVDR within the regulation timeline is critical for all Manufacturers (and NB) that are intending to place/continue to place IVD Medical Devices in the EU market. It is also critical to ensure patients in the EU have access to safe and state of the art IVD medical devices.
Consistent and higher quality TD files will facilitate the assessment by NB and positively impact the speed at which the conformity assessment can be completed. This will also allow more predictable timelines for both Manufacturers and NB.
The agenda of the workshop is as follows:

Workshop Agenda (Subject to Change)

*Every session will include a Q&A as well as practical exercises

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome

8.00-8.30 am Welcome and Workshop Introduction
Presenter(s):
Catherine Holzmann (GMED)
Tom Patten (NSAI)
Alex Laan (BSI)
Marta Carnielli (TUV Sud)

8:30 to 09:45 am The (pre)-application phase:
Structure of a TD file, NB code assignment as per MDCG 2021-14, classification, creation of sampling groups.
Presenter(s):
Catherine Holzmann (GMED)
Tom Patten (NSAI)

09:45-10:30 am
Directive to Regulation data: Completion of a gap assessment, tips & tricks, state of the art concept (Part 1)
Presenter(s):
Alex Laan (BSI)
Tom Patten (NSAI)

10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

11:35 am-12:00 pm
Directive to Regulation data: Completion of a gap assessment, tips & tricks, state of the art concept (Part 2)
Presenter(s):
Alex Laan (BSI)
Tom Patten (NSAI)

12:00-12:30 pm
Performance Evaluation and Clinical Evidence: IVDR Requirements and NB expectations
Presenter(s):
Catherine Holzmann (GMED)
Marta Carnielli (TUV Sud)

12:30 - 1:30 pm
All Workshop Registrants: Lunch

1:30 - 2:45 pm
Performance Evaluation and Clinical Evidence (continued): IVDR Requirements and NB expectations
Presenter(s):
Marta Carnielli (TUV Sud)
Catherine Holzmann (GMED)

2:45 - 3:30 pm
Post Market Surveillance & Post Market Performance Follow-Up: IVDR requirements & NB insights
Presenter(s):
Alex Laan (BSI)
Marta Carnielli (TUV Sud)

3:30-4:15 pm
Review of the Day. Tying it all together
• Summary of main elements
• Last questions
• Feedback and suggestions
Presenter(s):
Catherine Holzmann (GMED)
Tom Patten (NSAI)
Alex Laan (BSI)
Marta Carnielli (TUV Sud)

Learning Objectives:

  • Upon completion, participants will be able to acquire insight on the challenges of the assessment of the Technical Documentation
  • Upon completion, participants will be able to support the preparation of Technical Documentation files for IVDR conformity assessment
  • Upon completion, participants will be able to take informed decisions on critical elements of the conformity assessment process (e.g. device classification, NB code assignment according to MDCG 2021-14, provision of sufficient data to support the device intended purpose)