(EU) 2023/607 – 26 May 2024 Lodge your MDR application for an extended transition time, Get ready for your next surveillance audit!
With the Regulation (EU) 2023/607, the European Commission wants to address the risk of discontinuity in healthcare services caused by the slow transition from the medical device Directives to the MDR and IVDR.
In order to benefit from the extended transition timelines and continue placing legacy medical devices on the market, i.e. those who did not undergo significant change in their design or intended purpose[1] as per article 120(3c) of the (EU) 2017/745, the manufacturer shall establish a QMS compliant with the requirement of MDR 10 (9) by May 26 2024. Practically, as this will be assessed as from the 26th of September 2024 by your MDR NB through their surveillance audit, will your ISO 13485:2016 certificate be sufficient to meet the quality management system requirements of the (EU) 2017/745?
The MDR introduces additional, stringent requirements that go beyond those outlined in ISO 13485:2016 regarding post market surveillance, market surveillance, vigilance and registration pursuant to Article 120(3e) MDR.
Is your organization prepared for this transition? If not, you’re not alone. Navigating regulatory changes can be complex and time-consuming. That’s where confinis AG comes in.
At confinis AG, we specialize in regulatory compliance and offer comprehensive support to help your business seamlessly transition to MDR Requirements.
Our services include:
✅ Gap Analysis & Strategic Planning: Identify compliance gaps and develop a strategic plan tailored to your organization.
✅ Documentation & Process Alignment: Ensure all documentation and processes meet the updated standards.
✅ Training & Implementation Support: Equip your team with the knowledge and tools needed for successful implementation.
✅ Auditing & Continuous Improvement: Conduct thorough audits and provide guidance for ongoing compliance and improvement.
But our support doesn’t stop at ISO 13485:2021. We also offer strategic advice and solutions for future regulatory challenges, ensuring your business stays ahead of the curve.
Don’t wait until the last minute. Partner with confinis AG to achieve compliance efficiently and effectively. Contact us today to schedule a consultation and take the first step towards a compliant and competitive future.
Sabrina Campana
Head of Communication
+41 78 797 2099
sabrina.campana@confinis.com
About confinis:
confinis is a globally recognized consulting firm specializing in the field of medical devices, in vitro diagnostics, and combination products. With headquarters in Switzerland and a presence in the USA, confinis provides comprehensive and tailored solutions to meet the unique regulatory and quality challenges faced by organizations operating in these industries.
