Join Essenvia at RAPS Convergence 2026 — Booth #918
· Charlotte, 15–17 September
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Topic
EU MDR
Essenvia Insights: Collisions Are Inevitable at the Crossroads of MedTech Regulation and Device Innovation. Exhibit A: EU’s MDR Fender Bender (Part 2 of 2)
Part two of a two-part series: regulatory experts on how the EU MDR transition has affected device innovation, and what it has cost manufacturers.
Essenvia Insights: ‘Checkpoints’ or ‘Obstacles’? For Device Innovation, MedTech Regulation Can be Friend and Foe (Part 1 of 2)
Part one of a two-part series: regulatory experts on whether MedTech regulation accelerates or obstructs device innovation — and when it does each.
A MedTech RIM Can Play a Vital Role as Companies Transition to EUMDR
The ever-evolving world of medical device regulations presents an era of continuous change, most notably with the EU’s Medical Device Regulation (MDR). Industry experts warn that noncompliance with the rule’s requirements could land MedTech manufacturers in hot water.
MDCG guidelines on the Periodic Safety Update Report (PSUR) - How can IVD Manufacturers Benefit
What MDCG-2022-21 means for IVD manufacturers: who must file a PSUR under IVDR Article 81, what it contains, and how legacy devices are treated.
The Ultimate Guide to Medical Device Classification for US FDA and European Union’s Medical Device Regulation (MDR)
If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company must first ensure that the device is in compliance with each target region’s medical device classification requirements.
Your Guide to European CE Mark for Medical Devices
Launching a new medical device is a highly regulated process whether you are looking to sell in the United States or other countries. To go to market within the European Union, you must first obtain a CE mark for your medical device. Please keep reading to learn about what a CE mark is, why it’s important, and how to get one.
What is GSPR (General Safety And Performance Requirements) for EU MDR and EU IVDR?
Establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.