Post Marketing Surveillance on Medical Devices – US FDA Working Groups
Two public meetings were organized by the United States Food & Drug Administration (FDA) on post market Surveillance System and the good use of registries in post market.
The 1st meeting was held on September 10th, 2012 with the purpose to solicit public feedback regarding FDA’s proposal to strengthen the national medical device post market surveillance system.
The 2nd meeting took place on the 12th and 13th September 2012. The purpose of this meeting was to discuss best practices for use of registries with medical device data for post market surveillance, clinical studies, and evidence appraisal.
According to the participants, the current device surveillance landscape has a passive and enhanced reporting system and it often fails to collect quality data in a timely fashion. These data are not sufficient, since they lack critical device information (ex. model) and fail to be leveraged for pre-market uses.
Both workgroups were focused on the following necessities:
- The effort to develop a national, integrated infrastructure of electronic healthcare data systems for medical products safety surveillance via “Sentinel”
- The launch of “mini-sentinel”, a pilot project sponsored by the U.S. (FDA) for an active surveillance system – the Sentinel System – to monitor the safety of FDA-regulated medical devices
- The critical role of registries who provide clinically rich information but also fills a critical void in absence of a unique device identifier (UDI) – In the EU market, this number already exist under the name Global Medical Device Nomenclature (GMDN) Code
- The need to establish a unique device identification (UDI) system and promote its incorporation into electronic health information
On a European level, an enforced surveillance system already exists on medical devices through the EC Directives (MDD 93/42/EEC, IVD 98/79/EC, AIMDD 90/385/EEC) but also by other means such as the 2010/227/EU Decision which contains provisions on the European Databank for Medical Devices (Eudamed) aimed to strengthen market surveillance and transparency in the medical devices’ sector.
The role of the European Authorized Representative (EAR) is not only to act as the vigilance contact point in Europe once the CE marking has been obtained but also to guide and support the manufacturer in his Post Marketing Surveillance activities.
Such indications can be found in the recently published guidance document by the European Commission, the MEDDEV 2.5/10 “Guideline for Authorized Representatives”