EU Regulatory Importer Requirements for Medical Device Software (MDSW)
While the MDCG has worked extensively on building up the library…
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Medical Device Risk Management for Device Manufacturers
Like other types of therapeutic products, risk is…
European Authorized Representative Under MDR/IVDR: IGJ Inspection
The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards.
Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
According to the EU MDR, post-market surveillance (PMS) is the “proactive,…
Common Mistakes When Undergoing MDR Notified Body Agreements
The revised transitional provisions of the MDR allow for the following devices to be placed on…
3 CE Marking Regulatory Challenges and Proven Solutions
Embarking on the process of introducing a new medical device or in vitro diagnostic (IVD) product to the market…
EU Regulatory Importer: Legal Liabilities & Considerations
Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an…
IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
IVDR Clinical Performance Studies: Considerations for EU Approval
In other articles, we have covered considerations for manufacturers about clinical investigations when pursuing CE marking under the…
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