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.

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal products to medical devices.

EU regulators have launched a public consultation in conjunction with a process review of the Transparency Directive (89/105/EEC) intended to revise pharmaceutical pricing rules, which have not been updated since 1989. In addition, the consultation will involve evaluating whether the directive should also apply to medical devices.

Contributions from interested parties will be accepted until May 25; commissioners are particularly interested in comments from economic operators, health care professionals, public interest organizations and national authorities.

If regulators ultimately do extend the Transparency Directive to medical devices, that could lead to a more simplified and efficient pricing and reimbursement infrastructure for manufacturers across Europe.