The European Union Medical Device Regulation (MDR) is a regulatory framework that governs the approval, marketing, and post-market surveillance of medical devices within the European Union (EU). The MDR was introduced to replace the previous Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). The MDR aims to enhance patient safety, improve transparency, and adapt to advancements in medical technology.

Data governance within the context of the European Union Medical Device Regulation (MDR) involves establishing processes, policies, and controls to ensure the quality, integrity, and compliance of data related to medical devices.

Data Governance is critical for MDR compliance.

Effective data governance is essential for ensuring the reliability and integrity of data used in the MDR processes, from device development and conformity assessments to post-market surveillance. It contributes to regulatory compliance, transparency, and the overall quality and safety of medical devices in the European Union.

For example, Data Governance teams need to establish the following disciplines for MDR compliance.

  • Ownership and Stewardship of Product Data
  • Identification of Critical Data Elements such as Trade Name and Risk Class

Premier International's Data Governance In-a-Box methodology ties people, process and technology to support compliance with the MDR. For more information, please visit Figure 1 shows the 16-step process we use to help organizations set up their data governance foundation, take data governance from a niche organizational function, and bring it to enterprise-wide relevance. We tailor a plan specifically to your business.

Figure 1: Premier International's 16-step Data Governance process