MEDIcept Insights
New Brazil Regulation for Medical Devices Now In Effect – Steps to Take
The new medical device regulation for Brazil, Regulation RDC No. 751/2022, issued on 21 September 2022, is now in force as of 01 March 2023. The Brazilian Health Regulatory Agency (ANVISA) updated the prior regulation (No. 185/2001) to provide for risk classification,...
EMA Scientific Advice Pilot for Firms Seeking EU MDR Approval – What Does This Pilot Mean for Medical Device Companies?
Background Beginning February 27, 2023, companies with early-stage, high-risk medical devices will have the opportunity to start submitting letters of interest to participate in the European Medicines Agency (EMA) scientific advice pilot. This pilot will give an...
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)...