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Document 32022R1107
Common specifications for in vitro diagnostic medical devices
Регламент за изпълнение (ЕС) 2022/1107 на Комисията от 4 юли 2022 година за определяне на общи спецификации за някои медицински изделия за инвитро диагностика от клас D в съответствие с Регламент (ЕС) 2017/746 на Европейския парламент и на Съвета (текст от значение за ЕИП)
- Legal basis:
- 32017R0746 - A09P1
- Initiative summary:
- These common specifications for certain class D (highest risk) in vitro diagnostic medical devices set uniform and consistently high requirements for device performance across the Union. Devices covered are those for detection and/or quantification of HIV, human T-cell lymphotropic virus, hepatitis B, C, D, vCJD, cytomegalovirus, Epstein-Barr virus, Treponema pallidum (syphilis), Trypanosoma cruzi (Chagas disease), SARS-CoV-2 and determination of ABO, Rhesus, Kell, Kidd and Duffy blood groups.
- EuroVoc thesaurus:
- здравна политика; безопасност на продукта; медикотехническо оборудване; обществено здраве; хармонизация на стандарти; безопасност на пациентите; техническа спецификация; медицинска диагностика; маркетингов стандарт
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- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Committee on Medical Devices
- Planned adoption period:
- 01/01/2022 - 31/03/2022
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2022)951115 (Draft implementing regulation)
- Legal basis:
- 32017R0746 - A09P1
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Committee on Medical Devices
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2022/4498 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32022R1107 (Implementing regulation)
- Date of publication:
- 05/07/2022