Community

European Commission just made a proposal for in vitro diagnostic medical device regulation regarding transitional provisions, i.e., the length of the transitional period depends on the risk .....

The pending MRA agreement between EU and Switzerland obliges foreign manufacturers to designate Swiss authorised representative, which raises the questions among the ......

What are your obligation as an importer and/or distributor if you plan to import or distribute your products in Switzerland? Very often, economic operators do not play only one role, i.e., ......

Cervical cancer remains one of the gravest threats to women’s lives worldwide. As an essential part of gold standard, colposcope plays a vital role in the diagnosis and treatment of cervical cancer.

Do you know if your medical device meets the regulatory requirement of “state of the art”? Can you answer your notified body’s question about the “state of the art” during the initial or ......

The new MDR emphasizes sufficient clinical evidence based on clinical data for demonstrating conformity of medical device and complements the clinical requirements of the MDD/ AIMDD ......

Understand and correctly identify the EMDN (European Medical Device Nomenclature) for your medical device as the device’s UDI-DI information is connected with codes .....

Understand the terms of harmonised European standard, standard and technical specification, which are important for the implementation of the EU Medical Device Regulation.