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.

Drug and Medical Device Modernization Law Nearing Adoption in France

Two versions of a draft law amending regulations of pharmaceutical and medical technology products in Francehave been adopted by the French National Assembly and Senate.

The modernization law sets up a collective redress system for litigation similar to class action lawsuits available in the US, and will necessitate reorganization of the French Health Products Safety Agency (AFSSAPS) as well as promotion and advertising of medical devices, according to Eucomed.

Under the law, medical device and pharmaceutical firms would be required to make public all benefits and perks they provide to health care providers, hospitals, patient groups and media. The French Ministry of Health has argued that the threshold for reporting by firms should be €1, but the actual threshold amount will not be determined until finalization of the law.

The National Assembly and Senate must now hammer out a final version of the law; if no compromise can be reached, the National Assembly’s version of the law will stand. Final adoption of the law is expected by the end of 2011.