IVDR Resource Center for IVD Manufacturers
Resources, news, and services from Emergo by UL to help IVD manufacturers comply with the EU's In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
UK Regulators Issue New Consultation on Updated Medical Device Regulations Slated for July 2023
UK MHRA seeks public comment on 2023 medical device, IVD regulatory updates
Post-Brexit Medical Device and IVD Oversight: A New Plan for the UK MHRA
UK MHRA foretells brave new world of medical product oversight with new Delivery Plan
Medical Device Direct Imports to Users in Switzerland
Swiss regulators develop importation plan for medical devices
Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers
Brazil ANVISA provides new details on proposed UDI framework for medical devices
European Regulators Offer New MDR Compliance Guidance for Legacy Medical Devices
European MDCG guidance identifies MDR compliance requirements for legacy devices based on task force report
UKCA Marking Delay: What it Means for Medical Device and IVD Manufacturers
UKCA certification deadlines pushed back, but not for medical devices (so far)
European IVDR Consulting and CE Marking Services for IVDs
We help prepare CE marking submissions for IVD devices in compliance with the European IVDR, including support for IVD device certification and approval.
INVIMA Medical Device Registration and Approval in Colombia
Emergo can help your medical device company with determining device classification before registering for Columbia's INVIMA regulatory approval.
US FDA 510(k) Consulting for Medical Devices and IVDs
Learn about the FDA pre-market notification 510(k) submission process, US FDA 510(k) consulting for medical device submission and CDRH clearance.