FAQ - MDR Transitional provisions new EU Medical Devices Regulations | CAMD 2018
Appunti Marcatura CE | ||
13 Novembre 2024 | ||
Salve Visitatore | ||
FAQ - MDR Transitional provisions | CAMD 2018 Implementation of the new EU Medical Devices Regulations The Competent Authorities for Medical Devices (CAMD) Executive Group recommended the establishment of an Implementation Taskforce for the new EU Regulations for Medical Devices (MDR) and in vitro Diagnostic Medical Devices (IVDR) to facilitate collaboration and cooperation within the medical devices network during the implementation phase of the new regulations. The objective is to implement an effective, robust, predictable and secure regulatory system and ensuring better protection for public health in the medical devices sector. The taskforce is not intended to replace or prevent any national-specific implementation planning or activity that a competent authority wishes to conduct. Following a decision at the May 2017 CAMD meeting in London, an additional group was established – the Transition Subgroup – with the remit of providing clarity on the transition provisions of the MDR and IVDR. MDR/IVDR Transition Subgroup The MDR/IVDR Transition Subgroup has developed some FAQs to provide clarity. The key objectives of the Transition Subgroup are to: Contents: Glossary: https://www.camd-europe.eu/ Collegati |
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