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.

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.

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.

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

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.

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

European Union member states should take immediate steps to

Final publication of the European Commission’s regulations covering electronic instructions for

De Europese Commissie heeft het volgende persbericht uitgegeven naar aanleiding van voorstellen voor twee nieuwe...

In addition to recent draft regulations concerning medical devices and in vitro diagnostics, the European Commission has drafted additional reforms (“PIP Action Plan”) aimed specifically at greater control of Notified Bodies. The draft Regulation on Designation and Supervision of Notified Bodies and Recommendations for Audits and Assessments have been drawn-up by means of the Standing Committee-mechanism described in Article 7 of the MDD 93/42/EEC (and Article 6 of the AIMDD 90/385/EEC). Therefore, these changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.