The Netherlands
In 2021, the EU-regulations for medical devices regarding safety and efficacy have become more strict under the implementation of the MDR. This implies that some CE labels have to be updated and a selection of medical devices now need a CE-label, while this was not the case according to the previous legislation. The MDR foresees a transition deadline, by when manufacturers must comply. Those deadlines were extended last year. Because of that extension, CE certificates issued under the old rules are valid longer than May 26, 2024.
During this transition period however, the manufacturer needs to comply with a number of conditions.
As of now, the IGJ is focusing its inspections on 2 specific conditions, both of which apply to manufacturers of medical devices:
1) The manufacturer had to submit a new request to a notified body by May 26, 2024.
2) The manufacturer needs to have a signed agreement with the notified body for the assessment of the medical device no later than September 26, 2024.
The Health and Youth Care Inspectorate will perform checks in the upcoming months to verify whether these conditions are met for manufacturers under their supervision.