Since May 2021, the new Medical Device Regulation (MDR) has been mandatory for many medical devices – with consequences for their availability.

Source: Pexels

Demand for improvement

As the DIHK and partners were able to show in a survey, there have been delays in certification since then, which in turn lead to bottlenecks. Particularly affected: Pediatric, orthopedic and obstetric products.

On January 6, 2023, the EU Commission has now decided to extend the transition periods. “The availability of safe medical devices for patients in Europe is our priority,” the corresponding press release states.

Deadline extension according to risk factor

The extent to which the deadline is extended depends on the type of medical device. For medium- and low-risk products – which include syringes – the deadline now ends in December 2028. Medical devices with a higher risk – such as pacemakers – the transition period only applies until December 2027.

Background information on the EU Medical Devices Regulation can be found here.

Source: EU Commission, DIHK