Preconference Workshop: IVDR Technical Documentation

Description: 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the lack of consideration of requirements that impact all aspects of TD e.g. risk management documentation being out of date and make the approval of the TD very difficult.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.

This workshop is intended to be a follow on to the previous workshop last year with more time and depth spent in key areas of conformity assessment. The workshop will also address specific elements relating to the TD of IVD medical device software (IVD MDSW) via a review of the specificities of the technical documentation for IVD MDSW.

The aim of this workshop is to explain NB expectations; with reference to the Team NB TD Best Practice document for IVDR including practical exercises on, for example, the definition of a device intended purpose and device classification. The workshop will include an extensive session on the performance evaluation requirements, including post-market performance follow-up, as many deficiencies are identified within this chapter of the Technical Documentation. It will also include feedback on the experience gained with the assessment of post-market surveillance data and reports.

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.

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.

Agenda
8.00-8.30 Registration
8:30 -10:30 IVDR Annex II Technical Documentation – common pitfalls identified in the definition of the intended purpose, device classification,
design & manufacturing information, selection of applicable GSPRs
Introduction and review of the state of the art concept
10:00-10:30 Workshop Refreshment Break
10:30-12:00 IVDR Annex II Technical Documentation – common pitfalls identified on Performance Evaluation and Clinical Evidence
12:00-13:00 Workshop Lunch
13:00-14:30 IVDR Annex II Technical Documentation – common pitfalls identified on Performance Evaluation and Clinical Evidence
&
Post Market Surveillance & Post Market Performance Follow-Up: IVDR requirements & NB insights
14:30-15:00 Coffee Break
15:00-15:50 IVD MDSW: The specificities of the Technical Documentation of IVD Medical Device Software Marco Caproni (TUV Sud)
15:50-16:00 Review of the Day. Tying it all together

The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!