• EU IVDR Regulation

EU IVDR Regulation: A Brief

February 22nd, 2023|

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The PIP breast implant scandal brought to light weaknesses in the overall regulatory process [...]

  • Literature Review

Literature Reviews for EU MDR

February 18th, 2023|

Want to know what the most commonly criticized document in an MDR submission is?Your clinical literature review.Reviewing the literature is essential to the clinical evaluation process for medical devices. The clinical evaluation report assesses a [...]

  • Vigilance Reporting Under the MDR

Vigilance Reporting Under the MDR: Insider’s Guide

January 17th, 2023|

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations. [...]