Europe: Patient care with innovative medical products will become more difficult

Results of a business survey

The companies in this sector, which is mainly characterised by medium-sized enterprises, expect considerable difficulties in bringing innovations to market in the future: 79 % of the companies see this as a serious consequence the MDR. Almost three quarters of all companies see cost increases in market access with great or even very great concern. Every third company even considers his existence at risk.

Many companies are planning to withdraw products from the European market so that they will no longer be available for healthcare.

DIHK/SPECTARIS claims
  • A key objective must be to avoid the supply of medical devices in times of regulatory transition phases falter or even completely is failing.
  • In addition to the important safeguarding of patient well-being, policy must also ensure the preservation give more attention to the competitiveness and innovative strength of industry.
  • In order to be able to develop and market innovative products, companies need a reliable legal framework which not only grants the necessary freedoms but also provides legal certainty.
  • In addition, special rules should be introduced for proven existing products, e.g. in the form of protection of existing products, which are not covered by the extension option
    until 2024.
  • For niche products with a small number of cases (so-called orphan medical devices) special arrangements should be introduced to ensure that innovative products will continue to be developed.
Author(s)Source
DIHK | Deutscher Industrie- und Handelskammertag e.V., SPECTARIS. Deutscher Industrieverband für optische,
medizinische und mechatronische Technologien e.V.
Self-published, Vogel Verlag, Jan 2019 (german)
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