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T-04: Understanding Pharmacovigilance Challenges and Complexities in Medical Devices: US and EU Perspective

Poster Presenter

      Sanjeev Miglani

      • Founder and Director
      • AWINSA Life Sciences
        United States


The objective of the study: • Understand how the management of safety for medical devices differs from drugs • Differentiate between medical device pharmacovigilance regulations in the US and EU • Describe the challenges in the US and EU and, how the upcoming new regulations will address them.



A review of the regulatory systems and literature for the US and EU was done. A comprehensive assessment of the safety reporting requirements in the medical device space was done for the US and EU to understand the various challenges, and differences and similarities amongst them.


Although medicines and devices are regulated under European Union and the United states law, the regulatory regimes are very different. The safety reporting time lines for the devices are stringent and based on the remedial actions taken for them. The United States and the European Union approach the challenges in different ways. Whereas the United States has always relied on a strictly centralized process through 1 agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 28 different countries as they combined to create the European Union. The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.” The EU system has drawn criticism for conflicts of interest in its evaluation process, and a recent recall of a popular silicone breast implant that was approved only in the European Union has reinforced European concerns about the clinical evaluation of high-risk devices. In order to strengthen the regulations in medical devices, the European Parliament adopted two new regulations on 5 April 2017. They will be published in the official Journal. The new rules will apply three years after publication with regards to the medical devices. US FDA too at the same time is taking initiatives to ensure that safety monitoring is robust both preapproval as well as post approval.


Central approval process in the US allows post-market phenomena in one generation of devices to inform later applications and study designs. This also provides publicly searchable listings and databases of adverse events. Though individual Notified Bodies may be motivated to provide a predictable and streamlined approach to attract customers, there may be inconsistency in the process for approving similar devices among Notified Bodies. Additionally, review of Notified Bodies not made public; post-marketing data shared among Competent Authorities but not with the public. Open presentations to advisory committees describe particularly novel, complex, or high-risk devices, and Summary of Safety and Effectiveness Data provides the justification for approval as well as discussion of adverse events. In the European Union, Notified Bodies have no obligation to publish their decision-making process or the evidence provided by sponsors. E.U. patients have faster access to certain devices, but these products are marketed with less rigorous proof of effectiveness and may have a greater chance of later-identified adverse events. The new rules in the EU which will apply three years after publication with regards to the medical devices will bring significant changes in the system. The position of notified bodies will be made stronger. There will be strict monitoring for them. Eudamed database will provide patients, healthcare professionals and the public with comprehensive information on devices placed on the EU market. Also, the new regulations would withdraw the principle of equivalence and require further clinical trials in medical devices, which would especially affect class III devices