Learn From Past Mistakes: Preparing For MDSAP and International Commercialization

Marcelo Trevino, Senior VP, Regulatory Affairs and Quality Systems, Applied Medical

In today’s complex and frequently changing medical device world, it is more important than ever to fully understand regulations — particularly those regarding communication with Notified Bodies — to be capable to comply with quality and regulatory desires in Europe. Regulatory literacy will be even more critical as organizations begin implementing MDSAP requirements to comply with desires from the U.S. (FDA), Australia (TGA), Brazil (ANVISA), Canada (Health Canada), and Japan (MHLW / PMDA). The task is particularly challenging to small and early stage start-up organizations, where there is pressure to quickly release a medical device products in the market. 

In this article, I will summarize some of the most common European regulatory compliance mistakes I have seen over the last few years, as well as provide insight on how to avoid them.

U.S. Regulatory Clearance Does Not Equal CE Mark/Worldwide Approval

Many organizations assume regulatory clearance in the U.S. can be used as a gateway to CE Mark approval in Europe, and all over the world. However, there is no mutual acknowledgment among regulatory agencies and, particularly in Europe, there are multiple organizations responsible for regulatory approval: notified bodies, member states, and competent authorities. While getting clearance from the FDA can make the CE Mark procedure easier (organizing technical files/design dossier), organizations should have a clear understanding that the approval procedure is judged by a different set of criteria.

Medical devices in Europe are governed by medical device directives (MDD: Medical Device Directive, AIMD: Active Implantable Medical Device Directive, IVDD: In Vitro Diagnostics Directive). In addition, depending on the device technology, there are other directives that might apply to each device.

Previous FDA regulatory clearance does not affect a certification decision; to commercialize a product in Europe, the product must meet the important requirements dictated by the appropriate Directive for that product. The same concept applies when commercializing products in other parts of the world.

 

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