Translation of "Types diagnostic methods in the medical laboratory " (English → French) :

1. European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them.

(iii) proven laboratory experience in one of the following areas: testing or calibration laboratory, supervisory authority or institution, national reference laboratory for class D devices, quality control of in-vitro diagnostic medical devices, development of reference materials for IVDs, calibration of diagnostic medical devices; laboratories or blood banks which experimentally assess and use high-risk IVDs or, where applicable, manufacture them in- ...[+++]house;

(60) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adaptation to technical progress of the general safety and performance requirements , of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies , of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical performance studies; the establishment of the UDI system; the ...[+++]information to be submitted for the registration of in vitro diagnostic medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical performance studies; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them.

If we expand our scientific knowledge, we must review the Council’s recommendation on early diagnosis and improve diagnostic methods for more types of cancers.

Results of the investigations and of further typing or other method of characterization in laboratories (for each category reported on separately)

was analysed by a random sampling of at least five containers from each processed batch by laboratory diagnostic methods to ensure adequate heat treatment of the whole consignment as foreseen under point 1; and