Webinar | IVDD to IVDR: Mind the Gap Before You Apply
DNV and MedEnvoy present a one-hour webinar on 9 December 2026 on the IVDD to IVDR transition for Class B and Class A sterile IVD manufacturers preparing for the 2027 milestones.
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 1–9 of 1001
How Much Does It Cost to Register a Medical Device with the FDA in 2027?
FDA fees for medical device registration depend on classification. The FY 2027 annual establishment registration fee is $13,785, plus pathway fees for 510(k), De Novo, and PMA submissions.
AI at RAPS 2026: Where Regulators and Industry Agree. Recap with Rocio Fallas
AI was among the most discussed topics at RAPS Convergence 2026. Rocio Fallas shares her impression of where regulators and industry agree, and what manufacturers should prepare for in 2027.
Economic Operator Compliance: Why Shipments Get Stuck Despite a Valid CE Certificate
A valid CE certificate and a clean audit history do not guarantee that a shipment clears the border. Daryl Wisdahl and Brittany Dunning explain what does.
UK Government Confirms Indefinite Recognition of CEMarked Medical Devices in Great Britain
On 21 October 2026, the UK government confirmed it intends to indefinitely recognize CE marked devices certified under the EU MDR and IVDR in Great Britain. GB obligations remain.
Swissmedic Activates swissdamed Importer Linking
Swissmedic made the importer linking function available in swissdamed on 1 October 2026. Swiss importers must now link their…
What is Premarket Approval, and Does Your Device Need It?
Most Class III devices need Premarket Approval, the FDA's most demanding pathway. Here is what the PMA process involves, from trials and application contents to review stages and common mistakes.
Health Canada Medical Device Shortages
Health Canada has revised its medical device shortage guidance. New reporting windows, advance notice requirements and a broader discontinuation rule apply from 17 June 2027.
FDA Expands 510(k) Exemptions: Clinical Toxicology Test Systems for Federal Drug Testing Programs
The U.S. Food and Drug Administration (FDA) has published a final order expanding 510(k) exemptions for…
Showing 1–9 of 1001