Articles – Resources – AKRN Social network
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
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
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
Checkout our selection of resources about medical devices and clinical writing.
This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages.
Keeping this cookie enabled helps us to improve our website.
Please enable Strictly Necessary Cookies first so that we can save your preferences!
More information about our Cookie Policy
AKRN Social Network