Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
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.
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.