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Branchenumfrage: Revision der EU-Medizinprodukterichtlinien könnte Unternehmen 18 Milliarden Euro kosten

Die Ergebnisse einer vom europäischen Dachverband der Medizinprodukte-Unternehmen Eucomed durchgeführten Umfrage (Text auf Englisch) deuten darauf hin, dass Medizinprodukte-Unternehmen in der Europäischen Union bis 2020 bis zu zusätzliche 17,5 Milliarden Euro für die Compliance aufwenden müssen, wenn ein zentrales Marktzulassungssystem als Teil der Revision der Medizinprodukterichtlinie umgesetzt wird.

New Whitepaper Urges Better Reimbursement Process for CIED Telemonitoring in Europe

European Union regulators must develop a robust country-level reimbursement framework for remote monitoring of cardiac implantable electronic devices (CIED), according to a new whitepaper by PriceWaterhouseCoopers, the European Heart Rhythm Association (EHRA) and Eucomed.

Medical Device Trade Groups Sign On to Global Compliance Statement

Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation. Eucomed has published a position paper, European Health and SMEs: Big Challenges, Small & Medium Sized Solutions, following a survey the group conducted over the course of 2010 of 12 European national medical technology industry associations to pinpoint major regulatory barriers to SMEs.