Senior Vice President, Global Regulatory and Quality at Beaufort - A Different CRO Experience | In Vitro Diagnostics (IVD) | Regulatory Affairs | Companion Diagnostics
Quick update to the post below, the anticipated Q&A document has been published by the European Commission. You can review the document here: https://lnkd.in/g5cRaht2 The 17-paged EXTENSION OF THE IVDR TRANSITIONAL PERIODS document is a "Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices". There is a helpful flowchart in the appendix that helps with understanding the conditions and deadlines for placing ‘legacy devices’ on the market or putting them into service in accordance with Article 110 IVDR, as amended by Regulation 2024/1860. Happy reading and, as always, don't hesitate to reach out to Beaufort CRO if we can be of help.
Senior Vice President, Global Regulatory and Quality at Beaufort - A Different CRO Experience | In Vitro Diagnostics (IVD) | Regulatory Affairs | Companion Diagnostics
Regulation (EU) 2024/1860 amending Regulations (EU) 2017/746 (#IVDR) and (EU) 2017/745 (#MDR) and has been formally published in the Official Journal of the European Union (OJEU). The date of publication is the date the legislation enters into force. As a reminder, key updates include: 1. Extension of Transitional Provisions: While there is an extension of IVDR compliance dates for certain in vitro diagnostic medical devices (Class C and B legacy devices), others (Class D legacy devices) have earlier compliance deadlines. Of note there are new eligibility criteria related to the transitional periods with their own deadlines. 2. Gradual Roll-out of Eudamed: #Eudamed, the EU-wide database on medical devices, will have a gradual roll-out. Certain modules will become mandatory for use before all six modules are fully operational. 3. Obligation to Inform Authorities and Economic Operators: Manufacturers have an obligation to inform authorities and downstream economic operators in case of an interruption of the supply of devices. This requirement is set to begin in January 2025. The amendment provides additional time for some IVD manufacturers to transition to compliance with the IVDR. However, the eligibility conditions to make use of the transitional provisions may present challenges as they require manufacturers to meet specific deadlines for quality management system compliance and notified body applications. The European Commission is expected to release a Q&A document to provide further clarification on the implementation of Regulation (EU) 2024/1860. The full text of the regulation can be accessed on the Official Journal of the European Union website here: https://lnkd.in/gDbPVtxM
