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Template “Clinical Investigation Plan”
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Position statement by MedicalMountains GmbH on the proposal for a restriction on per- and polyfluoroalkyl substances (PFASs) (Jun. 2023)
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Explanatory notes on the transitional period in accordance with MDR (Jun. 2023)
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eIFU for medical devices (Jul. 2020)
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eIFU for medical devices (Nov. 2023)
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Current assessment of medical device manufacturers on the effects of the EU Medical Device Regulation (MDR) Dec. 2023
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Survey on the EU Medical Devices Regulation (2022)
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Suggestions for changes when implementing the MDR (Jul. 2024)
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Konformitätserklärung (DoC) unter Art. 120 MDR (Okt. 2024)
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eIFU comments from MedicalMountains on draft implementing regulation amending (EU) 2021/2226 (Mar. 2025)
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Position on the planned classification of ethanol as a CMR substance (Apr. 2025)
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Towards MDR 2.0: Further proposals for proportional regulatory reforms to ensure availability of essential medical devices (Jun. 2025)
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Impact of MDR and IVDR – Results of the industry survey (Oct. 2025)
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