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.

Markets: EuropeTags: class action, European Union, france, medical device

Author: Stewart EisenhartDate: November 7, 2011

40-year EU Patent Impasse at an End?

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 more streamlined, less costly and truly centralized process for patent approval.

In a December 13, 2010 post on the blog medtechinsider.com, UBM Canon Editor in Chief Norbert Sparrow notes that medical technology developers accounted for the largest number (more than 12%) of patents filed with the EPO in 2009; according to Sparrow as well as recent Financial Times news (registration required), 10 countries including heavyweights Germany and France have appealed to EU internal market commissioner Michel Barnier to allow those countries to pursue a centralized patent approval system without the involvement of other member states, if necessary (much to the chagrin of Spain and Italy).

If the EU can successfully instill final approval authority within the EPO and do away with the current country-by-country patent granting and approval process, the ramifications for medical device and IVD manufacturers should prove quite beneficial. Caveats regarding the sometimes glacial pace of EU reform processes must of course be emphasized, but nonetheless progress—even if in slow motion—is progress.