The European Commission has released an updated Q&A document on the gradual roll-out of EUDAMED, now accompanied by a helpful flowchart.
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Gradual Implementation: EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality.
- ???????????????????????????????????? ????????????: Each module becomes mandatory 6 months after the publication of a notice in the Official Journal of the EU.
- ???????????????????????? ????????????????????????????????????????????????: Devices must be registered either from the applicable date or upon relevant vigilance actions.
- ???????????????????????????????????? ????????????????????????????????????????????????: The staggered approach aims to enhance transparency and safety across the MedTech sector.
- ???????????????????????????? ???????????????????????? ????????????????????????????????????????????????: The new flowchart was developed by MedTech Europe and adopted with minimal changes.???????????????? ???????????????????????? ????????????: Manufacturers, importers, and Authorised Representatives are encouraged to register early to ensure a smooth transition. If you need support with the registration process or navigating the new requirements, feel free to reach out to us at info@eumediq.eu!???? ???????????????? ????&???? ????????????????????????????????: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf