Die Europäische Kommission hat eine inoffizielle Version ihrer regulatorischen Anforderungen für Benannte Stellen veröffentlicht, die eine wesentliche Rolle bei der Erlangung der CE-Kennzeichnung für Medizinprodukte spielen. Obwohl die veröffentlichten Anforderungen keine Referenznummern oder Datumsangaben enthalten, gibt das Dokument klare Hinweise darauf, wie die Benannten Stellen diese Anforderungen einzuhalten zu haben.

The European Commission has published draft regulation covering electronic instructions for use in the European Union that would affect both device medical device manufacturers and notified bodies.

The European Commission has issued a new version of the "Manual on Borderline and Classification...

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices. EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989.

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.

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable cardiac devices a key element of its four recently submitted proposals to the European Commission Innovation Union Strategy's Active and Healthy Ageing Innovation Partnership program.

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs). The new rele

The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a mor

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC (which amends the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC).

European medical technology trade association Eucomed has issued a new position paper advocating six major changes to how the European Union regulates medical devices.