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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,
AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)
Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe TOLEDO, OHIO and MADRID, SPAIN β MARCH 21, 2022 NAMSA, a
Performance Studies for SARS-CoV-2 IVD tests
Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD
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
IVD Clinical Performance Studies
IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for
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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