Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

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.

Eucomed has advocated greater use of remote monitoring of cardiac devices among EU health care providers in order to both improve chronic cardiac care and reduce costs by potentially more than €5.6 billion annually. But facilitating widespread adoption of remote monitoring devices will require setting up permanent reimbursement mechanisms, Eucomed argues, as current models do not properly account for these capabilities.

The other three proposals Eucomed has submitted to the European Commission include:

  • Developing procurement systems such as those in the UK and Sweden that prioritize innovative products
  • Facilitating research on the influences of national and local procurement decisions
  • Establishing more effective community care in lieu of hospitalization for conditions such as stoma, wounds and incontinence