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European Federation of High-tech Industries

eurom

The European Federation eurom is an EU-level umbrella organisation whose members represent the interests of manufacturers from high-tech industries, especially the laser and photonics as well as the laboratory and medical technology.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

EUROM welcomes the opportunity to provide feedback on the targeted revision of the EU rules for medical devices (MDR) and in vitro diagnostics (IVDR). This revision should aim to reduce bureaucratic burdens, strengthen governance and accountability, lower costs, foster competition and innovation, support small and medium-sized enterprises (SMEs), ensure consistency with horizontal legislation, and address future challenges facing the sector. To achieve these objectives, we believe the following key steps are essential: i. Relieve pressure on the system through short-term measures ahead of the revision proposal. ii. Address bureaucratic burdens and known issues while taking advantage of quick wins. iii. Transition towards a sustainable framework with a central governance structure. iv. Future-proof the regulations. Please see the attached file for more details.
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Response to Implementing regulation for electronic instructions for use for medical devices

21 Mar 2025

Eurom welcomes the European Commissions initiative to revise EU regulation 2021/2226. Electronic Instructions for Use (eIFU) will improve accessibility, searchability, and flexibility for medical device professionals. It also strongly aligns with goals related to sustainability, resource and climate protection, and the essential digitalization needed in the EU to maintain global competitiveness. We believe the draft successfully achieves its intention. Although, some sections of the text need clearer wording to avoid any possible misunderstandings.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

The European Federation eurom High-Tech Industries welcomes the opportunity to provide feedback to the Targeted Evaluation of the Medical Device and IVD frameworks. Medical Devices and IVDs are highly developed technologies that drive the European economy and ensure state-of-the-art healthcare for its citizens. For this reason, it is essential that they are regulated by a fit for purpose framework that ensures a high level of health and safety for patients and users while fostering competitiveness and innovation. The MDR and IVDR are in many ways excellent tools to achieve these goals (harmonized across member states, risk based). However: In practice many of the provisions in the MDR and IVDR have proven to be overly bureaucratic, burdensome and costly, leading to product discontinuation and a decline in innovation. eurom therefore believes that it is vital for the sector and the future of the European medical device industry, that urgent legal measures are taken to revise the medical device frameworks. This revision should serve to address bureaucratic burden, ensure accountability through governance, cut costs, foster competition and innovation, support small and medium enterprises, ensure consistency with horizontal legislation, future-proof for new technology and address future challenges the sector may face.
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