MDR Annex XVI Common Specifications Adopted by European Regulators
New provisions cover products with no intended medical purpose
FDA Asks COVID Test Makers to Switch from Emergency to Premarket Approvals
The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.
UK Regulator MHRA to Raise Medical Device Registration and Other Fees by 10% or More
The UK’s MHRA invited public comment regarding its proposed fee increases.
FDA Launches TAP Pilot to Speed Access to Safe and Innovative Medical Devices
The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.
US FDA Issues Roadmap to Medical Device Regulatory Guidance Topics List for 2023
The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.
European MDCG Issues Recommendations to Strengthen Notified Body Capacity
New European MDCG paper lays out actions to increase Notified Body capacity, avoid medical device and IVD shortages
US FDA Proposes Updates to Breakthrough Devices Program Guidance
The US FDA has issued draft guidance on select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility.
European Notified Body Survey: MDR, IVDR Certification Numbers Remain Low
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
US FDA Sets Some Steep Increases for 2023 Medical Device User Fees
The FDA released its 2023 medical device user fees and some have increased sharply since last year.
Health Canada Reminds EHR-based Medical Device Manufacturers of Regulatory Rules
Health Canada reminded manufacturers of EHR-based medical devices to obtain a medical device license and/or establishment license.