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Fri

Jan, 16 2026

Artificial Intelligence in Post‑Market Surveillance of IVD Assays 

Introduction  Post‑market surveillance (PMS) is the ongoing monitoring of device safety and performance once a...

Wed

Sep, 03 2025

The Future of IVDs: How e-Labeling is Revolutionizing Compliance & Sustainability 

The digital transformation of the medical technology sector is no longer an emerging trend but...

Thu

Aug, 08 2019

What is UDI (Unique Device Identification)?

UDI is one small part of a complete revamp of European Medical Device (MDR) and...

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MDR Guidelines

Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide

Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices

TÜV SÜD – Fact Sheet

MHRA – MDR – IVDR Guidance

Worldwide regulation resources

USA Regulatory Framework Medical Device registration

Taiwan Regulatory Framework Medical Device registration

South Korea Regulatory Framework Medical Device registration

South Africa Regulatory Framework Medical Device registration

Singapore Regulatory Framework Medical Device registration

Saudi Arabia Regulatory Framework Medical Device registration

Russia Regulatory Framework Medical Device registration

Peru Regulatory Framework Medical Device registration

New Zealand Regulatory Framework Medical Device registration

Mexico Regulatory Framework Medical Device registration

Malaysia Regulatory Framework Medical Device registration

India Regulatory Framework Medical Device registration

Hong Kong Regulatory Framework Medical Device registration

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