Reporting obligation for medical device manufacturers 'is not feasible'

The wish of a number of hospital umbrella organizations that Minister Bruno Bruins (Medical Care, VVD) imposes a reporting obligation on manufacturers of medical devices is unfeasible. This is what Luc Knaven, director of FHI Medical Technology, says in NRC.

According to Knaven, it is often not clear to manufacturers of medical devices how long they can continue to supply a product. According to Knaven, the biggest bottleneck lies with the European inspection bodies that have to certify the aids. He advocates more inspection bodies that can issue certificates. Currently, only nine of the 55 authorities are allowed to do this.

Knaven is responding to a possible impending shortage of thousands of medical devices. This shortage is said to be caused by the fact that many medical products must comply with stricter European rules from May 26, while the current inspection capacity is said to be insufficient. This threatens to stall the certification process.

Ad Melkert recently stated that Minister Bruins must intervene because patients are in danger of becoming victims. For example, some manufacturers are said to be withdrawing products from the market because they find the inspections too expensive. However, the minister is reluctant to introduce a reporting obligation, partly due to the fact that the medical device market is extremely diverse with hundreds of thousands of different products.

Read the entire article at NRC.