EU

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.

Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.

The European Union’s regulatory community appears to be a flurry of activity with new MEDDEV guidance, updated standards lists, and a newly released roadmap for the much anticipated recast.

A new report issued by the European Commission and the Organization for Cooperation and Economic Development (OECD), Health at a Glance: Europe 2010, shows health-related spending by European governments increasing year over year, with the public sector accounting for the bulk of financing. On average, EU members spent 8.3% of GDP on health-related expenses compared to 7.3% in 1998. Countries including Germany, Switzerland, Austria and France allocate more than 10% of GDP on health, while Cyprus and Romania spend less than six percent.

The European Court has recently ruled to limit member states’ authority to restrict medical

New medical device guidelines, MEDDEV 2.7.4, addressing clinical investigations have been issued in the Eu

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