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How manufacturers and importer can safely and smoothly navigate through the IVDR transitional period for IVDD-certified devices......

Sponsors planning to conduct clinical trials for medical devices in Switzerland or multi-centre clinical trials including Swiss investigational sites should be aware of the changes .....

As a non-European country, Turkey has long recognized European CE-marking for medical devices and in vitro diagnostic medical devices. Following the two statements issued by EU-Turkey Customs

What will the European market for medical devices look like after 2024, when EU MDR is fully applicable? What are the challenges to manufacturers, importers/distributors .......

Under the new Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDs), some IVDs* certified according to the former directive (IVDD) i.e. legacy devices can continue to be

What is the summary of safety and clinical performance about? How should this document be structured, prepared and presented to users to meet requirements of EU MDR?

Swissmedic just updated its guidance regarding the economic roles that must be indicated on the device before it is placed on the Swiss market. As a result, this buys medical device .......

Procedures for technical review and approval of medical devices, published by the Medical Device Evaluation Centre of the NMPA (Chinese competent authority).