News - News
19 news items
As of 1 September, all medical devices must again have a CE marking
Updated 10 December As of 1 September 2020, all medical devices used by care providers must have a CE marking. Since mid-March, ...
Clinical trials with trial participants can be gradually (re)started
Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently ...
Export licence for personal protective equipment in the healthcare sector no longer necessary
As of 26 May 2020, it is no longer necessary to apply for an export licence for the export of certain items of personal ...
Clinical trials with trial participants in clinical research units can be gradually (re)started
Due to the corona crisis Phase I clinics are closed for the majority of the clinical trials conducted at the clinics. Since the ...
Change in export licence for personal protective equipment in healthcare sector
An export licence is required for the export of personal protective equipment from the Netherlands to countries outside the EU. ...
Coronavirus: impact on the conduct of clinical trials
The coronavirus outbreak affects the conduct of clinical trials under the Medical Research involving Subjects Act (WMO) and also ...
Personal protective equipment in the healthcare sector subject to export licence
An export licence is required for the export of personal protective equipment, such as face masks, splash goggles, and gloves, to ...
Instruction to register the supply of alternative medical devices
A manufacturer, authorised representative, distributor, or importer can register the supply of an alternative medical device with ...
Coronavirus: More flexibility for manufacturers and suppliers in case of shortages of medical devices
As a result of the coronavirus outbreak, there may be shortages of medical devices that are critical for delivery of professional ...
Coronavirus: consequences for GMP and GDP inspections and certificates