MEDIcept Insights
New Guidance Released on EU MDR Vigilance Terms and Concepts
The EU Medical Device Coordination Group has recently released document MDCG 2023-3 titled “Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices.” Its goal is to help competent authorities, economic...
US Reimbursement for Medical Device and IVDs – What Startups Should Know
Reimbursement is a critical part of getting a medical device or in vitro diagnostic (IVD) to market. Reimbursement can impact your design, regulatory strategy, and financial returns on medical devices. Understanding the key components of reimbursement allows for a...
Guidance on the Health Institution Exemption Under Article 5(5) of EU MDR and EU IVDR
In-house medical devices are exempted from most of the provisions of (EU) 2017/745 (Medical Devices Regulation) and (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation), given that the health institution follows the conditions laid out in Article 5(5) of the...
VALID Act Fails to Pass – What to Expect for the Future of LDT Regulation
Regulatory reform of Laboratory Developed Tests (LDT) has been a long time in the making, but lawmakers and industry groups alike are debating to what degree of oversight is appropriate. Legislation called the VALID (Verifying Accurate Leading-edge IVCT Development)...
Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions
Human Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing device/user interfaces. To help manufacturers understand the extent of human factors (HF) information required in...
Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary...