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The diagnostic sector is facing stringent EU legislation to be implemented in May 2022. In order not to harm patients, availability of medical tests should be guaranteed. However, due to unreadiness of the EU regulatory infrastructure, a diagnostic collapse is looming if nothing happens.
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This page is a summary of: Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis, Clinical Chemistry and Laboratory Medicine (CCLM), September 2021, De Gruyter,
DOI: 10.1515/cclm-2021-0975.
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