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Masarykova univerzita

MUNI, MU

Masaryk University since its foundation in 1919 as the second oldest Czech university occupies a position of the second largest higher education institution in the Czech Republic in terms of the number of students.

Lobbying Activity

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

26 Feb 2025

Compliance with MDR and IVDR regulatory requirements is difficult, especially for small and medium-sized companies, due to the complexity of the new regulation, the high cost of certification and testing, and the challenging clinical trials. For small companies with only a few employees and producing few products in this category, strict compliance with the rules and obligations can be almost liquidating. This also applies to the need to recertify those medical devices which, for example, have been on the market for many years, were widely used and did not carry any major risk to patients, but according to the new regulation, the missing clinical studies had to be completed or were moved to a different, higher risk class of medical devices in terms of the new classification, with the need to apply for a new certificate. If these SMEs do not find suitable strong partners, it is better for them to withdraw from the market and stop manufacturing and selling their devices. This then leads to a deficiency of MD in certain areas. This, of course, has a negative impact not only on the health of EU citizens. Another difficulty is the very limited number of notified bodies, especially for specific categories of medical devices, where there is a very long waiting time for recertification and certification and there are no fixed deadlines (such as for pharmaceuticals) for NBs to issue an opinion and certificate. In addition, language barriers can also play a role, where the manufacturer has to choose a NB from a different country than where it is located, which often results in higher costs for the whole process. Another negative thing is the fragmentation of competences between NBs and Concerned Authorities, where, for example, each may have different opinions and requirements for clinical studies.
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Meeting with Ondřej Krutílek (Member of the European Parliament)

17 Jan 2025 · The future of EU science and research support after 2027

Response to ESF+ mid-term evaluation

1 Feb 2024

Masaryk University continues to perceive the support from ESF+ as a crucial source of funding to further improve the quality of higher education and support its global competitiveness. In relation to the foreseen deeper transformation of the EU cohesion policy in the new programming period 2028 - 2034 (whether due to the enlargement of the European Union, further structural changes, etc.), the European Social Fund (ESF+) can be considered to undergo certain changes in its setting. We recommend to use the experience from the setup of instruments within the NextGen Europe package (e.g. RRF), where even within the frame of soft measures the support should be more directed to structural reforms and larger systemic projects with positive synergistic effects (education, social policy, etc.) rather than to stay fully within place based approach - thus also within the next ESF+ to consider a greater penetration of the so called performance-based principles approach to its implementation. Concerning some particular issues, Masaryk University would like to address the compliance with the DNSH principle and screening of infrastructure for climate impact should be addressed/ensured at the programme level, not in the selection of operations, where the burden in some cases falls on the applicant. In the context of mainly sectoral operational programmes with non-proprietary support targeted at areas such as education, social services, etc., these are argumentatively quite redundant operations that are completely invariant in terms of DNSH. Also the eligibility of VAT is fundamental for financing of public managed operations, including university projects, and national legislation should be respected in this issue.
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Response to Mid-term evaluation of the ERDF, the CF and the JTF 2021-2027

7 Oct 2023

Masaryk University welcomes the continuous support of higher education and research by the ESIF. Nevertheless, we would like to add some comments and suggestions for further improvement of the Cohesion policy implementation: - Synergies with other community programmes although progress is significant, more shall be done. The start of these activities must already be in the programming stage, e.g. in common terminology (or dictionary with terminology and what it means in different programs). - The stability of rules is crucial. Therefore, we highly praise the relative stability of the rules of the cohesion programmes. This is a good achievement. - New instruments, such as in the current period Recovery and Resilience Facility or Just Transition Funds, take a long time to be correctly implemented at all levels (EU, national, regional). It can take 2-3 programming periods until the system is well functioning. Our experience is that there is a lot of open questions on these new instruments. - A continuous building and strengthening of absorption capacity is needed. It is not only the role of the Managing Authorities, but mainly of various intermediaries in the regions, e.g. regional innovation agencies, SME associations, NGOs, etc. This shall lead to a more strategic approach.
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Response to Ex post evaluation of the European Regional Development Fund and the Cohesion Fund 2014-2020

7 Feb 2022

Masaryk University (Brno, Czech Republic) welcomes the opportunity to express its comments on the implementation of ERDF and CF. For Masaryk University, it is essential to practically enable and emphasize synergies between ERDF and other EU instruments supporting R&D (Horizon Europe) as well as reducing the administrative burden connected with these synergies. Already realized investments in R&D infrastructure had a major impact on Masaryk University's research output and accelerated its further development in this field. It is essential to continue the trend of reducing the administrative burden, especially at the level of final beneficiaries, throughout the whole implementation process (including streamlining e-systems, etc.). It is necessary, especially on the part of the implementing authorities in the individual Member States, to set up processes that will integrate the systematic interface relating to, for example, the findings of the audit authorities on the ESIF methodical systems (unambiguous environmental processes). Furthermore, to promote systemic communication between the different managing authorities, under the coordination of the national contact points, on the setting up specific steps in the operations' framework that have as their source the relevant Structural and Investment Funds (mainly ESF and ERDF). We recommend continuing to promote complementarities between the different funds, particularly ESF and ERDF, and linking them with other instruments. Further work is needed on the concept of sustainability of project outputs, especially in relation to the substantive aspect of development projects, i.e., rationally grasp the so-called technical sustainability associated with, for example, demonstrating the use of even minor specialized equipment.
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Meeting with Thierry Breton (Commissioner) and European Environmental Bureau and

5 May 2021 · Implementation of the chemicals strategy for sustainability

Response to Long Term Investment Funds – Review of EU rules

25 Sept 2020

Masaryk University welcomes the possibility to give feedback on ELTIF rules. Masaryk University, as an academic institution, considers the existence of ELTIF as very helpful for promoting innovation dissemination and "triple helix" (public, academic, private) cooperation. Therefore, because the support of university spin-off companies as well as long term public-private partnership projects addressing crucial future issues such as security, resilience, and aging of the population, is essential, we would appreciate keeping the administrative burden as low as possible. The framework should take into account especially necessity to support, for example, spin-offs after the initial grant (the aim of ELTIF), where besides the low administrative burden, also the support's high flexibility should be taken into account. In addition, the simplification of the state aid rules connected should be taken into close consideration as well.
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Response to Evaluation of European Social Fund support to education

11 Jan 2019

Masaryk University welcomes and fully supports this initiative and is continuously emphasizing the paramount importance of ESF interventions for development of education. Masaryk University also underlines the necessity of evaluations and consultations on ESF interventions between the stakeholders/beneficiaries and the Commission for agreement on possible modification of goals to reflect the everyday reality of research and academic institutions. Our priorities remain in the field of quality of educational programmes with relevance for the labor market, infrastructure for education with cutting-edge technologies, internationalization, mobility, communication with the public concerning the need for lifelong learning and improvement of qualification for better competitiveness.
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