Economic Operators: New Responsibilities Shake Up MedTech
One ill-prepared EO can impact the entire supply chain.
Tag Archives: European Union
How to Get More Mileage Out of Your Electronic IFU
Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.
Capitalizing on Standardized International Product Data
The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.
EU MDR:
Will You Be Able to Sell Your Medical Device in Europe after May 26?
This online series of workshops will arm you with the information you need to overcome challenges and achieve compliance with EU MDR.
IVDR: Go with the Flow
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears
With May 26, 2020 quickly approaching, every day counts.
How Are Medical Device Companies Addressing EU MDR?
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
Biotronik’s EU MDR Certification a ‘Huge Milestone’, Says GlobalData
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
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.
New MDR: One Year into the Transition Period
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
