UK Update: Start of the New Year and MHRA Announces Road Map
The medical device regulator for the UK, the MHRA, has posted the 2024-2025 UK regulatory roadmap to illustrate its plans for the year.
EU Update: New Guidance on Exemptions to Clinical Investigations for High-Risk Medical Devices
Medical device makers in the EU will want to take note of new guidance regarding exemptions to clinical investigation requirements for high-risk medical devices.
Israel Update: Declaration Route for Low-Risk Medical Devices Now in Effect
The Israeli Medical Devices Agency (AMAR) has implemented revised registration requirements for some Class I medical devices and IVDs
2024 EU MedTech Outlook: Economic Operators
The Medical Device Coordination Group (MDCG) has published guidance to facilitate the interpretation of the roles involved in gaining access to the European medical device market.
Brazil ANVISA Announces a Revised IVD Regulation RDC 830/2023
Updates to the regulation include alignment with administrative provisions from the RDC 751/2022 on medical devices and some hints on what to expect next.
Integrated Risk Management Throughout Device Lifecycle
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about integrated risk management.
FDA Announces Intent to Classify Certain Solid Wound Dressings
On November 30, 2023, the FDA announced in the Federal Register its intention to classify certain types of wound dressings that had remained unclassified as pre-amendment devices; i.e., devices that were in commercial distribution before enactment of the Medical Device Amendments of May 28, 1976.
EU MDR Update: Significant changes to FAQ on clinical investigations
EU medical device makers and clinical investigation sponsors should review updated FAQs from MDCG regarding significant changes to the clinical investigations section of MDR 2017/745.
EU MDR PMS Including PMCF and Vigilance
In this on-demand webinar, our Emergo by UL subject matter expert outlines the latest insights about EU MDR PMS, including PMCF and vigilance.
EU Compliance, Strategies and Goals for MDR and IVDR
Emergo by UL professionals gave an update on EU Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR, 2017/746) compliance.