“Implants must be more strictly regulated,” says federal agency
Belgium’s federal Health Care Knowledge Centre has spoken out against the lack of inspections and regulations around the manufacturing of medical devices, such as implants and pacemakers
Quality and safety not assured
Currently, only a CE mark is required for manufacturers to put medical devices on the market. The CE mark – a mandatory label of conformity for certain products sold in Europe – confirms that the product meets the requirements of the applicable EU directives. But this procedure is not enough to guarantee quality or safety, according to KCE.
The agency said that manufacturers should be required to prove that the product has a positive effect on health and provides added value compared to existing treatments. Manufacturers of medication, for instance, do have to prove this. KCE also denounces the lack of testing of medical devices, which are often not tested on humans before hitting the market.
The agency also pointed out that the inspection agencies responsible for approving a CE mark are not always completely independent or sufficiently experienced. KCE has asked for the establishment of one central agency in Europe, or a number of specialised agencies.
Stricter EU legislation is on the way, but KCE is advising the Belgian government to take measures now. Trial studies on humans could, for example, be made compulsory, it said.
