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.
From farming to teaching to firefighting, there are many principles of non-medtech professions that can be applied to EU MDR implementation.
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.
Here are the most read articles of the year.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
A gap assessment provides a toolbox for the decision-making process.
Lack of preparation and understanding of the efforts required to comply with the regulation will hinder product launches, negatively impact sales, and hurt a company’s reputation.
Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.
The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.