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.
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.
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.
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.
Registration is now open for the MedTech Regulatory Intelligence Summit in Washington, DC, May 16-17. Join us as we take a closer look at strategies and best practices in developing an effective and sustainable regulatory strategy for today’s global market.
“Content of Human Factors Information in Device Marketing Submissions” and “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” are now open for comment.
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.
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.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.