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What is CE marking and do all products need CE marking?
Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under
The importance of registering and posting clinical trials in a public database
Clinical investigations, commonly referred to as clinical trials, play a pivotal role both in developing new treatments and in detecting, diagnosing,
List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is
What is the IVDR?
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
ISO 20916 new international standard for IVDs
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
ISO 20916 for IVD vs. ISO 14155 for Medical Devices
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
What is MedTech?
MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing,
List of Member States’ Competent Authorities for Medical Devices
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
List of Notified Bodies under MDR (EU) 2017/745 on Medical Devices
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity
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