GHA/Regulatory Ark Working Group: MDR threatens export-oriented medtech industry

The “Regulatory Ark” working group of the GHA – German Health Alliance is currently examining the impact of the MDR on the SME-dominated and export-oriented German medical technology industry.

The first digital working group meeting took place at the end of June under the leadership of Armin Smajilovic, Head of Marketing and Sales at Haeberle, and Erhard Fichtner, Chairman of the Board of Directors of GHA. From Fichtner's perspective, the new regulatory requirements for medical devices "pose an immense threat to the entire medtech industry in Germany." In agreement with other industry associations, they are calling for a significant improvement and feasibility of the MDR regulation. In particular, export deliveries and thus the foreign business of the mostly medium-sized companies are severely threatened by the new regulations.

Fichtner warns: "The new MDR guidelines significantly reduce the competitive opportunities for German medtech manufacturers in the international market. The effort required to comply with these new regulations conflicts with the start date of the new regulations. It is impossible to recertify all products by the 2024 deadline because the personnel, notified bodies, and technical requirements are currently lacking or insufficient." Transitional solutions for existing products, realistic deadlines, and significant improvements in the requirements are needed "to keep the German medtech industry afloat."

Published in the industry information service MTD-Instant (MTD-Verlag, www.mtd.de)