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the lack of consideration of requirements that impact all aspects of TD e.g. risk management documentation being out of date and make the approval of the TD very difficult.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

The aim of this workshop is to review notified body (NB) expectations about TD considering the information within Team-NB Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 as well as the latest updates of relevant guidelines.

To promote the exchange among the participants and the NB, each session will include one or more polls on specific aspects of the TD (e.g. device classification, state of the art concept).

IVD Manufacturers will be able to hear about most commonly encountered pitfalls in the TD files directly from a group of NB and ask questions on this topic. Experience with the involvement of EURLs in the conformity assessment of class D devices will also be shared, if available.

As the deadlines for transition to IVDR for Legacy devices approach, it is critical for all Manufacturers and NB to maximise the efficiency of the conformity assessment process.

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
08h00-8h30 Workshop Registration & Welcome
08h30-09h45 The (pre)-application phase: Structure of a TD file, NB code assignment as per MDCG 2021-14, classification, creation of sampling groups.
09h45-10h30 Directive to Regulation data: Completion of a gap assessment, tips & tricks, state of the art concept (Part 1)
10h30-11h00 Coffee break
11h00-11h30 Directive to Regulation data: Completion of a gap assessment, tips & tricks, state of the art concept (Part 2)
11h30-13h00 Performance Evaluation: How to demonstrate Performance Evaluation
13h00-14h00 Lunch
14h00-14h30 Performance Evaluation (continued)
14h30-15h45 Clinical Evidence and Post Market Surveillance: IVDR requirements & NB insights
15h45-16h00 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!