The European Commission has released an updated Q&A document on the gradual roll-out of EUDAMED, now accompanied by a helpful flowchart.
𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬:
Gradual Implementation: EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality.
- 𝐌𝐚𝐧𝐝𝐚𝐭𝐨𝐫𝐲 𝐔𝐬𝐞: Each module becomes mandatory 6 months after the publication of a notice in the Official Journal of the EU.
- 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧: Devices must be registered either from the applicable date or upon relevant vigilance actions.
- 𝐈𝐧𝐜𝐫𝐞𝐚𝐬𝐞𝐝 𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲: The staggered approach aims to enhance transparency and safety across the MedTech sector.
- 𝐌𝐞𝐝𝐓𝐞𝐜𝐡 𝐄𝐮𝐫𝐨𝐩𝐞 𝐂𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧: The new flowchart was developed by MedTech Europe and adopted with minimal changes.𝐓𝐚𝐤𝐞 𝐚𝐜𝐭𝐢𝐨𝐧 𝐧𝐨𝐰: 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!👉 𝐅𝐮𝐥𝐥 𝐐&𝐀 𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf