EU Update: New MDCG Guidance Document 10a
Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents.
Medical Device and IVD Registration in the UK
Stay informed on post-Brexit medical device regulations, including compliance changes and protocols impacting trade for manufacturers and distributors.
Japan PMDA Pre-Submission for Medical Devices
Learn more about how medical devices are authorized and the challenges foreign manufacturers face when seeking to register products in Japan.
Japan MHLW Ordinance 169 and Medical Device and IVD QMS Requirements
Find out how MO#169 and ISO 13485 vary and the audit processes for national, international and contract manufacturers entering Japan’s medical device market.
Structural Revisions to European Medical Devices Regulation Proposed
You might have heard some rumors already: Several European parliamentarians sent a joint motion for resolution to the European Commission (EC). On October 21st, 2024, a European Parliament resolution “on the urgent need to revise the Medical Devices Regulation” (2024/2849(RSP)) was submitted to the EC.
Regulation (EU) 2024/1860 and IVDR Compliance in Europe
In this on-demand webinar, our Emergo by UL subject matter expert will share insights on Regulation (EU) 2024/1860 and IVDR transition periods in Europe.
Introduction to Medical Device Labeling, Standards and Symbols
Discover more about medical device labeling, global challenges and how symbols and electronic labeling help provide key information and simplify compliance.
UK Medical Device Regulator MHRA Announces Legislative Updates
MHRA, the UK medical device regulator, gave a progress report on the agency's work toward completing its roadmap of medical device legislation.
Importer/Distributor MDR Requirements and Impacts for Manufacturers
In this on-demand webinar, our Emergo by UL expert shares insights on importer/distributor MDR requirements and impacts for manufacturers.
US FDA Updates Rules on VMSR Manufacturer’s Program
The U.S. FDA has finalized its 2022 draft guidance document Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.