Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
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EU Regulation 2024/1860: Key Changes for IVDR Compliance
New regulation amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR): Regulation (EU) 2024/1860: Gradual roll-out of EUDAMED, the obligation…
EU Regulatory Importer Requirements for Medical Device Software (MDSW)
While the MDCG has worked extensively on building up the library…
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 requires…
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…
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