Clock Starts for New EU MDR Transition Dates
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
Tag Archives: EU MDR
New Resource Sheds Light on FDA CDRH Regulatory Focus
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
E-labeling: The Road to Reduced Medical Device Packaging Material
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
Increasing Momentum in Medical Device Security
Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
Ask the Expert: EU MDR as a Trigger for Innovation
EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
Swiss National Council Votes To Accept FDA Approved Medical Devices
In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.
Life Sciences Labeling for Patient Safety
Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.
Veranex Acquires Medidee
The acquisition expands Veranex’s European footprint as well as the scale and scope of its clinical studies capabilities.
Device Labeling: Best Practices
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
