Articles tagged with: Manufacturers' duties

With Regulation (EU) 2025/1234, all devices intended for professional users can have electronic instructions for use.

The clear definition of useful life and its various interpretations for each type of device (active, software, single-use, implantable...)

Class I devices without a UDI code on their label are no longer compliant with current regulations.

The NIS2 Directive imposes cybersecurity obligations on medical device manufacturers that are medium and large enterprises.

The complete guide for healthcare providers and dentists for mandatory registration and storage of UDI codes from January 15, 2024.

The 5 less obvious aspects, ranked by impact, to manage in order to complete the MDR conformity assessment process.

We share the high-level scheme applied to our clients: the most straightforward approach to post-market surveillance.

All the steps to independently register UDI codes of medical devices in Eudamed, the European database.

All the steps to independently register an economic operator in Eudamed, the medical device database.

By April 30th of each year, it is mandatory to declare promotional activity expenses and pay the 5.5% contribution to the Ministry.