ISO 13485 Confirmed in 2025 — No Annex SL Update
Global Regulatory Shifts: What Companies Need to Know about Market Access and Representation
Introduction
Rules for placing medical devices, IVDs, and other regulated products on the market are changing fast. New EU regulations, adjustments in the UK and Switzerl...
ISO 10993-1:2025 – A New Chapter in Biological Safety for Medical Devices
Insight: Navigating the EU In Vitro Diagnostic Regulation (IVDR)
Published: September 2025
A New Era for In Vitro Diagnostics in Europe
The EU In Vitro Diagnostic Regulation (IVDR) – formally Regulation ...
The New EU Product Liability Directive (2024/2853): Implications for Medical Device Manufacturers
Strengthening EU Medical Device Governance: Industry Proposals for a More Efficient Future
July 8th, 2025.
The European medical technology sector is at a turning point. Recent discussions among leading stakeholders, including MedTech Europe, AESGP, COCIR, EAAR, EUROM, and FIDE, highlight a ...
Heightened Scrutiny on EU Post-Market Surveillance (PMS) Requirements by Dutch Health Authority
Post-Market Surveillance (PMS) is a cornerstone of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), requiring all manufac...
New EU MIR Form 7.3.1 Released – Overview of the impact for EU, UK, and Swiss Market Vigilance
Integrating Sustainability into EU, UK, and Swiss Representation Services
The medical technology (Medtech) industry is undergoing a paradigm shift where sustainability has become an essential business priority. No longer just a "ni...
FDA Final Rule: ISO 13485 Now Central to U.S. Medical Device QMS – Are You Fully Aligned?
What SME Manufacturers Need to Know—and How QNET Can Support You
The U.S. Food and Drug Administration (FDA) has finalized its Quality Management System Regulation (QMSR), marking the most significant...
Ensuring Regulatory Compliance: Navigating EU MDR and ISO 13485 for Manufacturers
In today's highly regulated market, manufacturers face stringent requirements to ensure their...
Cybersecurity in Medical Devices: Insights, Near Misses, and Lessons Learned
In an era of connected healthcare, medical devices are no longer isolated appliances — they form integral parts of hospital networks, software ecosystems, and patient data flows. While con...