Top 10: EU MDR Remains a Hot Topic in 2019
MedTech Intelligence readers continue to crave information about the new regulation.
Tag Archives: EU MDR
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.
Best of 2018 in MedTech
Here are the most read articles of the year.
EU MDR Post-Market Surveillance: Active, Integrated, Risk-Based, and Planned
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
First Step in EU MDR Compliance: The Gap Analysis
A gap assessment provides a toolbox for the decision-making process.
