In the media

How the right operating model for EU MDR compliance can support a global footprint

Hilde Viroux Maggie Chan

By Hilde Viroux, Maggie Chan

Med Device Online

29 April 2024

PA Consulting medtech expert Hilde Viroux and PA life sciences expert Maggie Chan co-authored a series on EU MDR Compliance for Med Device Online with Dona O’Neil from Northeastern University. In their third article, they explain how the right operating model can support the ongoing compliance as well as foster innovation and a global footprint.

In our previous article, “A Cost-Effective Approach To EU MDR Compliance,” we explained how manufacturers can navigate the cost compliance and risk of non-compliance with the EU MDR and concluded that manufacturers should focus on investing in solid process design, selecting the right technology, to develop a robust quality management system (QMS) aligned with an effective cost-reducing strategy. Alignment between the various functions, internal and external, supported by technology is the key to maintaining compliance in an efficient way. In this article, we will discuss how the right operating model can support EU MDR compliance, innovation, and international growth.

Global regulators are working together to align on requirements for medical devices in order to reduce discrepancies between regions. The IMDRF (International Medical Device Regulators Forum) states on its website “We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety.” Many countries are modelling their medical devices legislation on the European model, including, for example, the Australian Therapeutic Goods Administration, the Saudi FDA, and Health Canada. Even the U.S. FDA has recently aligned its QMSR (Quality Management System regulation) requirements with ISO 13485, the globally adopted ISO standard for a medical device quality management system.

Several global jurisdictions have aligned on a Medical Devices Single Audit Program (MDSAP), which allows the conduct of a single regulatory audit of a medical device manufacturer’s QMS to satisfy the requirements of these jurisdictions. Participating in the MDSAP program will not only reduce the number of site inspections but also will ensure the regulatory requirements of these jurisdictions are being met.

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