by In2Pharma | Jun 11, 2025 | News
Belgium The FAMHP published a section listing medical devices and in vitro diagnostic medical devices notified under Article 10bis of regulations (EU) 2017/745 and 2017/746, introduced by the regulation (EU) 2024/1860. The list includes medical devices that are...
by In2Pharma | Jul 10, 2024 | News
Europe Extension of the IVD Regulation Transitional Periods Brussels, 30 May 2024 – The EU co-legislators have adopted an amendment to the In Vitro Diagnostics and Medical Devices Regulations (IVDR and MDR), extending the IVDR transitional provisions and adding a...
by In2Pharma | Mar 28, 2023 | News
Belgium As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users. All actors that carry out an activity...
by In2Pharma | Feb 16, 2022 | News
The Netherlands On 1 January 2022, a new provision will be added to the chapter in the GMH* Code regarding transparency. This provision relates to the clarifying note that the GMH foundation publishes annually at the time of publication of the reports by the...
by In2Pharma | Jul 7, 2020 | News
Belgium In anticipation of the European regulations on medical devices and in vitro diagnostic medical devices, the FAMHP has updated the “My company” and “My activities” applications in its web portal. The main changes are: The addition of risk classes from...
