Share |

Patients & Safety

  • Brussels, 09 February 2012

    Industry supports European Commission in strengthening medical devices legislation

    The European medical technology industry recognises the need to improve the effectiveness of the current European regulatory framework for medical devices. Eucomed, the European industry association for medical technology, appreciates the European Commission’s swift reaction and clear proposal for a joint plan of immediate measures to strengthen the European medical devices legislation. After analysing the Commission’s proposal, Eucomed believes the measures are balanced and appropriate and will have a positive effect on patient safety.

    read more
  • Brussels, 08 February 2012

    Call for interested parties regarding apheresis connector harmonisation

    EBA, the European Blood Alliance, and Eucomed, the European medical technology industry association, are calling all stakeholders involved in the design, development and manufacturing of medical devices used for apheresis systems and associated solutions to participate in the project aimed at designing a new connector specific for apheresis.
    read more
  • Brussels, 09 January 2012

    Eucomed statement on PIP breast implant incidents

    The European medical technology industry association Eucomed notes with great concern recent press reports that the French firm Poly Implant Prothèse (PIP) may have violated the regulations by using unapproved industrial-grade silicone in some of its implantable products and by allegedly falsifying or withholding documents. If these or other allegations are confirmed, Eucomed strongly condemns PIP’s behaviour and breach of trust. Patient safety, public confidence, and ethical behaviour should always be the top priorities of any organisation active in the healthcare industry.
    read more
  • 25 February 2011

    European Commission objects to FDA remarks in a letter

    25 February 2011 - According to Reuters: “A transatlantic spat has erupted after a top U.S. official suggested European patients may be "guinea pigs" for medical devices with less government oversight. A senior official at the European Commission, in a letter obtained by Reuters, complained to the U.S. Food and Drug Administration this month about comments from the FDA's device chief, Dr. Jeffrey Shuren.....” For the full story please go to the Reuters website
    read more
  • Brussels, 28 January 2011

    EU regulatory system brings Europeans fastest access to medical technology without compromising safety

    A report of the Boston Consulting Group (BCG) shows medical device recalls in the U.S. and Europe occur at the same rate while the approval process in Europe is significantly faster. The decentralised oversight in Europe, which is the essence of the regulatory system, allows people to benefit from the latest innovative products while guaranteeing the highest level of patient safety and fostering innovation. The findings of the BCG report are in line with an earlier report by Dr. Josh Makower, one of America’s leading medical technology entrepreneurs, which detailed how patients in Europe get access to new therapies an average of two years before patients in the United States due to regulatory challenges at the FDA.
    read more