FHI, the Dutch trade association for Medical Technology, expresses its concerns about the introduction of the new Medical Device Regulation (MDR). This new regulation came into effect in May 2017. Until May 2020 there will be a transition phase from the old Medical Device Directive (MDD) to the new MDR regulations. Because the transition phase has been almost completely 'hijacked' for the purpose of setting up the new MDR system, there is hardly any time left for the medical industry to ensure that its products comply with the new regulations.
FHI is in favor of introducing stricter product regulations that increase safety for patients and healthcare professionals. However, in order to comply with the stricter regulations, sufficient time and capacity must be available. Furthermore, care must be taken to ensure that the introduction of regulations does not endanger the continuity of care and that new promising technologies remain inaccessible to the patient for a longer period of time.
The most important concerns at a glance:
In accordance with the new regulations, many more products must be tested by an independent Notified Body. Notified Bodies that want to test according to the new regulations must also meet stricter requirements themselves. Of the more than 50 Notified Bodies in Europe, there are now only 6 that are allowed to test according to the new rules. Many medical products must be tested again by May 2020. However, that capacity is not available.
The new regulations require that information about medical products be entered into a European database (EUDAMED). However, this European database is not yet ready. It appears that the introduction of this database will be postponed for two years.
Important innovations often arise from small companies. The new regulations, among other things, greatly increase the clinical burden of proof. The question is whether small innovative companies in particular have sufficient capacity to finance and bridge such costly procedures.
The lack of capacity of Notified Bodies, the high costs and the lack of clarity surrounding the introduction process of the MDR means that companies are considering whether to market medical products under the new regulations. Since a substantial number of medical technology companies have announced that they will withdraw product lines from the market, it cannot be ruled out that this will have consequences for the continuity of care. Mainly for products with locally (in the Netherlands) lower margins or, for example, orphan aids
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