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Roadmap to CE marking for medical devices and IVDs
Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the
The quality management system according to ISO 13485
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall βestablish, document,
Safety reporting for clinical investigations under the MDR
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
Progressive roll-out of the IVDR: extended timelines for certain IVDs
By the end of 2021, the European Parliament adopted the proposal of the European Commission to amend the EU 2017/746 in vitro diagnostic medical
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
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