EU MDR: Changing World of Classification
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
Tag Archives: EU MDR
EU MDR, UDI and Master Data: How to Ensure Label Compliance
Upgrading your enterprise labeling system could play a key role in ensuring compliance.
UDI Implementation: Progress, Challenges, Where We Are Now
U.S. medtech manufacturers must also prepare for the UDI requirements under EU MDR.
Top 10: EU MDR Remains a Hot Topic in 2019
MedTech Intelligence readers continue to crave information about the new regulation.
Regulatory Reporting: What can Medical Device Manufacturers Learn from Big Pharma?
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soon affect medical device manufacturers. What can be gleaned from their experiences?
Now You’re Speaking My Language: Modernizing Instructions for Use to Comply with MDR
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
Preparing for MDR: Don’t Forget about Class I Reusable Devices
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Keep Calm and Carry On… And Other Outlooks We Can Apply to MDR Implementation
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
EU MDR: What We Can Learn from Other Professions
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
Breathe Easy on CERs
The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.
