medical device classes

Medical Device Classes

Introduction United States Food and Drug Administration (FDA) regulates all medical devices manufactured in the U.S. The FDA regulations, coupled with European Commission regulations, nearly cover all international distribution of medical devices. However, not all manufactured medical devices go through the same regulations. Depending on the possible risk factors, safety, and reliability of the devices,…

EUDAMED

EUDAMED

Everything You Need to Know About EUDAMED: Preparing for the New Medical Device Regulation EUDAMED is the EU medical device database that came into effect in May 2021. The regulation, known as MDR (Medical Device Regulation), replaces the Medical Devices Directive (MDD) and sets new standards for medical device registration and market surveillance. It is…

ISO 13485 training

iso 13485 training

ISO 13485 training No medical procedure comes without risk, but this can be reduced through effective risk management and regulation of medical devices. A medical device is any instrument or machine used to diagnose, prevent, or treat medical conditions and diseases. ISO 13485 is a global standard used to audit businesses that use devices for…

FDA 510k database

FDA 510k database

Searching the FDA 510k Database for Regulatory Strategy: What Medical Device Manufacturers Need to Know? The FDA 510k database is an important tool for medical device manufacturers. Understanding how to use it can help you stay compliant with FDA regulations and strategically plan your regulatory strategy in the United States. Perform FDA 510k database search…

MDCG

MDCG

Everything You Need To Know About Medical Device Coordination Group (MDCG) The Medical Device Coordination Group (MDCG) is a regulatory body of health and industry experts with the goal to improve medical device coordination, ensuring the safe and effective use of medical devices in Europe. The group is mainly known for publishing MDCG guidance starting…

MDD vs MDR

MDD vs MDR

Understanding the Differences Between MDD vs MDR: The European Regulation There are many regulations in place that govern how medical device manufacturers can produce and supply their products. The EU has a few different regulatory requirements for medical devices. In Europe, there is the MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation).…

ISO 13485 pdf

iso 13485 2016

How to Comply with the New ISO 13485 2016 Standard? ISO 13485 2016 (or EN ISO 13485 2016 for Europe) is the latest standard for medical devices. It was published in July 2016, and it has a lot of changes from ISO 13485:2003. ISO 13485 2016 includes new requirements for quality management systems and documentation…

EU MDR standards

EU MDR harmonized standards

EU MDR harmonized standards first set released The manufacturer must justify and document the design steps of his device. He must verify compliance with the requirements of Annex I to the European Medical Device Regulation 2017/745 dedicated to general safety and performance requirements. EU MDR harmonized standards and reference requirements can be used for that…

What is the new EU MDR

EU MDR

What is the new EU MDR? Everything you need to know The European Union (EU) Medical Device Regulation is the latest step in regulating medical devices in the European Union and has been developed to strengthen the monitoring of the medical devices on the market and their manufacturers. The EU MDR has been made effective…

IVDR

IVDR

What is the IVDR?   There has actually been an EU Directive (98/79/EC) controlling in vitro diagnostic medical devices (IVDs). Nonetheless, troubles emerged with the analysis and also application of that Directive, especially that it provided only reduced degrees of examination for possibly ‘high risk’ devices therefore EU IVDR regulation was enacted. IVDR meaning is:…