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Canada-BC-VERNON Azienda Directories
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Azienda News:
- Latest Global Medical Device Regulatory Updates – 2025
Stay updated on medical device regulations worldwide, including FDA guidance, EU MDR updates, China’s regulatory reforms, and CDSCO risk classification changes
- Overview of Device Regulation | FDA
Device Advice Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting
- Top 5 Upcoming FDA and EU Regulations – What to Know for 2025
5) EU IVDR and MDR Extension – In 2025, medical device manufacturers will need to be particularly focused on the EU In Vitro Diagnostic Regulation (IVDR) and the EU Medical Device Regulation (MDR) extensions, both of which are critical for compliance in the European Union
- Global Medical Device Regulatory News – March 2025 Update
Class III and active implantable devices must meet UDI requirements by 1 July 2024, Class II and notified devices by 1 July 2025, and Class I devices by 1 July 2026 The UDI system also plays a key role in post-market surveillance, helping to track adverse events and device recalls
- The 5 Major Regulatory Focus Areas For Medical Device Compliance In 2025
Several rules and regulations have important due dates in 2025 and beyond for which manufacturers should start preparing The FDA rule on LDT has due dates for the coming four years, with the first one May 6, 2025
- SaMD and medical device registration in 2025: EU, MDSAP, or USA
This article explores three major regulatory pathways—the European Union (EU), MDSAP countries, and the United States (FDA)—assessing their regulatory requirements, approval timelines, and market opportunities in 2025
- New Year New Rules 2025 EU MDR - ventura-solutions. com
Stay ahead of 2025 regulatory changes for medical devices, IVDs, and combination products This blog covers key updates on EU MDR compliance, risk management, AI regulations, sustainability requirements, and more Learn how to navigate evolving standards and ensure seamless market access
- EU Update: Current State of Medical Device Regulations
Regulation 2024 1860 was officially released to extend the transition time for legacy IVDs, roll out EUDAMED, and require data on disruption in supply as Article 10a Medical Devices Regulation (2017 745, MDR) and the In Vitro Diagnostics Devices Regulation (2017 746, IVDR)
- EU Medical Devices Legislation: What You Need To Know Given Latest . . .
Devices on the EU market under the old rules can remain on the market under the transition periods The validity of certificates have been extended and depend on various criteria and conditions being met For medical devices, the deadline for such extensions is until December 31, 2027 or December 31, 2028 depending on the risk class
- An Overview of the Upcoming EU MDR Requirements
What follows is a high-level overview of the new EU MDR regulations now set to go in force in 2028 Leverage this information to ensure your medical device engineers fully understand the new requirements Additionally, these regulations also apply to legacy devices currently sold and in-use in Europe Let’s take a closer look
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