MedicalMountains GmbH
MM
MedicalMountains GmbH is an organisation that supports and networks all players in the medical technology industry.
ID: 766687696872-56
Lobbying Activity
Meeting with Olivér Várhelyi (Commissioner) and
18 Nov 2025 · Medical device review
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
MedicalMountains GmbH welcomes the European Commissions initiative to launch an early evaluation and possible revision of the MDR. The system continues to show critical deficiencies, making this step both urgent and necessary. Immediate short-term solutions via delegated and implementing acts are essential; in addition, legislative measures must follow to secure sustainable long-term improvements. As it stands, the MDR framework is not achieving its original objectives. Innovation is stifled, supply continuity is at risk, and predictability for manufacturers is lacking. Excessive and often unnecessary requirements, combined with disproportionate resource burdens, undermine competitiveness without delivering added value for patients or users. In close cooperation with industry, MedicalMountains has developed several concrete reform proposals, which are consolidated and attached to this submission. They are supported by SMEs and large manufacturers including companies that have already completed MDR certification and are fully aligned with high safety and performance standards. The focus is on removing or adapting requirements that add no value but strain manufacturers and notified bodies. Documents within the annex are: 1. "Towards MDR 2.0: Proposals for proportional regulatory reforms to ensure availability of essential medical devices" (Consolidated version of the papers Suggestions for changes by MedicalMountains GmbH for more planning security, reasonable effort, and lower costs when implementing the MDR (July 2024) and Towards MDR 2.0: Further proposals for proportional regulatory reforms to ensure availability of essential medical devices (June 2025) 2. Joint Opinion of D-A-CH industry associations: Strengthening the competitiveness of the MedTech sector through simplification, 31 July 2025 3. Joint Opinion of D-A-CH industry associations: Urgent need for legal measures to facilitate MDR/IVDR implementation, 25 November 2024 In addition, we draw attention to a forthcoming publication: "Impact of the EU Regulations MDR (2017/745) and IVDR (2017/746) on innovation, competitiveness and security of supply in the EU Results of a 2025 industry survey", conducted by BVMed, MedicalMountains, SPECTARIS and VDGH. This report will be published in October 2025 and will complement the evidence provided here. Kindly note: The order in which the concrete solutions in the attached documents are presented does not imply any prioritization. Current leverage points include Reduction of unnecessary clinical data requirements: (a) Criteria-based expansion of well-established technologies across all risk classes (b) No additional data for Class I/IIa devices compliant with ISO standards (c) Simplified evaluations for low-risk devices Simplification of PMS, PSUR and SSCP obligations Reduction of bureaucratic burdens: (a) Repeal of Article 10a MDR or replacement by a central platform (b) Elimination of duplicate vigilance reporting (c) Unlimited validity of certificates Adjustment of Classification Rules 6 and 8 Kindly note, that these points represent only a subset of our networks proposals in the attachment. Ultimately, this is not only about regulatory mechanics. It concerns Europes capacity to innovate, its global MedTech competitiveness, its economic and supply resilience, and above all patients timely access to safe and effective medical technologies.
Read full responseMeeting with Olivér Várhelyi (Commissioner) and
7 May 2025 · Situation of SMEs in the medical devices sector
Response to Implementing regulation for electronic instructions for use for medical devices
21 Mar 2025
MedicalMountains fully supports the European Commissions initiative to amend EU Regulation 2021/2226 and welcomes the possibility to comment on the draft implementing regulation within this consultation process. The initiative marks a significant step forward, as the broad use of electronic Instructions for Use (eIFU) will improve their accessibility, searchability, and flexibility for healthcare professionals, fostering at the same time sustainability, resource conservation, climate protection, and the essential digitalization needed for the EU to maintain global competitiveness. However, the amendment is also a major step forward in this respect, as a wide range of mass medical devices can now benefit from the use of eIFUs and their overall mass will increase exponentially. For this reason too, the practicality, clarity and efficiency of the regulation are essential if its implementation is to be successful. With regard to the draft text, we therefore propose a more precise wording in some parts of the text in order to avoid possible misinterpretations. We also suggest reconsidering some procedures for legacy devices. Our comments and suggestions can be found in the document attached.
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