MDR extension

The EU MDR transitional period extension : Q&A on the implementation of Regulation (EU) 2023/607

🚀 Three Essential Steps for Manufacturers to Extend MDD Certificates 🚀

1️⃣ Create a Regulatory Strategy and Timeline: Develop a comprehensive regulatory strategy, including timeline for the submission of your files for MDR conformity assessment.

2️⃣ Establish a MDR-Compliant QMS by May 2024: Implement a Medical Device Regulation (MDR) compliant Quality Management System (QMS) to meet the regulatory requirements before the deadline on 26 May 2024.

3️⃣ Agreement: Submit your formal application for MDR conformity assessment before 26 May 2024. Ensure it is signed and approved by the Notified Body before 26 September 2024. Include possible submission timelines in your agreement.

Feel free to reach out if you have any questions or need further guidance. Let’s succeed together! 💪🌟

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