- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > post-emergency-use-listing safety monitoring - medicines, IVDs, vaccines granted EUAL
- Keywords > selection process
- Keywords > in vitro Diagnostic (IVD)
- Keywords > in vitro diagnostic medical devices
- Keywords > WHO Model List of Essential In Vitro Diagnostics (EDL)
(2019; 50 pages)
The second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) was held from 18 to 22 March 2019 in Geneva. The objectives of the meeting were among others: to review the first WHO Model List of Essential In Vitro Diagnostics (EDL), to consider submission of new tests and general input from stakeholders, to review and make recommendations for the Second EDL and to discuss on eligibility criteria for prequalification of IVDs.
WHO secretariat prepared a working draft of the second EDL for open consultation and for review by the SAGE IVD members. The proposed Second list was developed based on changes proposed to the first EDL, submissions for new product categories, a suggested list of general laboratory and anatomical pathology tests and a report on therapeutic drug monitoring tests.
All the procedures were transparent and based on input from internal and external stakeholders, SAGE IVD members and members of the public interested in policy or implementation of the EDL. All the suggested changes, submissions, reviews and responses to the reviews were published on the WHO website for comment, and all public comments received were acknowledged.
The agenda and members of the SAGE IVD as well as all background documents, were posted under: https://www. who.int/medical_devices/diagnostics/selection_in-vitro/selection_in-vitro-meetings/sage-ivd-2nd-meeting.
The Second WHO Model List of Essential In Vitro Diagnostics (EDL) and its explanatory notes, are presented in this document which will become the annex to the report of the second SAGE IVD meeting. The notes describe the objectives, limitations and guidance for its use.
The full report of the Second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) is being finalized, to be published in August -September 2019 as part of the WHO Technical Report Series. The final report will present a full description of the methodologies, reviews, evidence, references and recommendations of the SAGE IVD members and will be found at: https://www.who.int/medical_devices/ diagnostics/selection_in-vitro/en/.