The BioMed Alliance Taskforce on IVD, in collaboration with the European Haematology Association and the European Federation of Clinical Chemistry and Laboratory Medicine, conducted a survey on the current use of different IVD tests in diagnostic laboratories.

The objective of the questionnaire was to gain insight into the current situation for medical laboratories, in particular on the degree of preparedness of medical laboratories for the IVDR implementation, and to make an accurate assessment of the potential impact that the IVDR will have on diagnostic laboratories and their test menu. In total, we received 203 answers from medical laboratories across the EU and Norway. We analysed all the responses received and elaborated a report showcasing the main results as well as some explanatory figures.

The results to the questionnaire showed that respondents represent 25 out of 27 EU countries, with a wide range of diagnostic fields and laboratory types. Responses show notably that compliance to the IVDR will be a major effort for diagnostic laboratories, requiring trained personal, additional time and budget. It was also clear that guidance documents are urgently needed to help diagnostic laboratories to properly conduct the transformations required from the IVDR, and many respondents see the availability of appropriate guidance both as an issue/problem and a solution. According to the respondents, various forms of guidance could be used, whether as templates, practical examples, or workshops, once again requiring appropriate resources. Furthermore, it stands out from the responses that postponement of the date of application of the IVDR was greatly needed in order to ensure the continuity of high-quality diagnostic care of patients. Fortunately, this action has already been initiated in October 2021 by the European Commission. Therefore, the diagnostics labs call on the European Parliament and the Council to quickly adapt the regulation timelines and on the MDCG and the Commission to continue the work according to the Joint Implementation Plan, particularly with respect to appropriate guidance documents.

For more information, you may read the entire report on the main findings here.