MTI Regulatory Roundup: global medical device regulatory update
Global look at regulatory compliance, guidance, trends and deadlines.
Tag Archives: medical device regulation
FDA Outlines its Approach to Artificial Intelligence Regulation
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
MHRA Releases Roadmap of Future UK Medical Device Regulation
“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward.”
Bringing your Medical Device to the UK: What You Need to Know about UKRP
The UK is an appealing market for MedTech businesses, but there are some important issues that companies will need to be familiar with to ensure they fully understand the UK regulatory landscape. The role of the UK Responsible Person is one of the most important.
Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
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.
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.
FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices
“Content of Human Factors Information in Device Marketing Submissions” and “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” are now open for comment.
Legal and Normative Requirements: Ensuring the Functional Safety of Medical Devices
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
Ask the Expert: Leveraging the Digital Infrastructure to Align with Best Practices and Accelerate Growth
In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.
