𝐌𝐃𝐑 𝐄𝐱𝐭𝐞𝐧𝐬𝐢𝐨𝐧: 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐋𝐚𝐭𝐞𝐬𝐭 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 𝐢𝐧 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬
The MDR and IVDR aim to improve the safety and performance of medical devices & IVDs, as well as increase transparency and accountability in the industry. The European Commission proposed an extension for the MDR deadline, which was later approved by the European Parliament and the Council of the European Union. The extension was granted to give manufacturers, notified bodies, and other stakeholders more time to prepare for the changes and ensure compliance with the new regulations. Let us look at the revised timeline here.