Increasing Role for Device Patient Safety in Device and Combination Products in the European Union

Shweta Agarwal, Paula Burge, and Chris Holmes for Medtech Strategist

To ensure better protection of public health and patient safety, the European Union adapted a series of stricter regulatory frameworks and compliance requirements for medical devices. 

As the May 26, 2020, deadline for the new Medical Device Regulation (MDR 2017/745) compliance approaches, medical device companies must get up to speed on what’s changing, challenges to anticipate, and how to transition effectively to compliance. The sweep of the reforms is broad ranging. This article provides an overview of the major changes, factors to assess and overcome, and guidance on creating an optimal process, with a special emphasis on post-market safety monitoring and reporting requirements.

MDR Fundamentals

The MDR differs significantly from the existing Medical Device Directive (MDD) and affects the quality assurance, clinical data, technical documentation, post-market plans and surveillance activities, and product labelling. Specifically, the new legislation:

  • Reinforces the criteria for the designation of notified bodies and processes for their oversight.
  • Introduces stricter premarket control of high-risk devices.
  • Strengthens clinical and post-market surveillance (PMS) requirements.
  • Improves transparency through establishment of EU database on medical devices (EUDAMED) and traceability requirements based on Unique Device Identification (UDI)
  • Adds proactive reporting requirements after commercialization.
  • Increases roles and responsibilities for all economic operators.
  • Expands the definition of “medical device” to include software, nonmedical and cosmetic devices that are similar in function and risk profile to medical devices, listed under Annex XVI, even if they do not have an intended medical purpose.

What this means in practical terms for manufacturers is many legacy products will need to be recertified, many devices will be reclassified as higher risk (See “Raising the Class I Alarm: How EU MDR Impacts Low-Risk Device Manufacturers,” this issue TKTK), and devices in development will be held to a more rigorous approval process. 

Importantly, because the new MDR legislation is formed as a “regulation” rather than a “directive,” the EU law is directly applicable at a national level without requiring transposition through specific national legislation of the individual 28 member states. This should allow for greater legal certainty and prevent variation in the approach taken or in the rules relating to medical devices. 

Manufacturers should carefully consider the impact and financial implications of meeting the new requirements, and plan early for the transition. Market access will require companies to conduct deep portfolio audits to determine the impact on margins, assess unique device identifier readiness, relabel products, and ready data for public release. It all adds up to complex change program and high remediation cost. Meaning, from an operational viewpoint, companies can anticipate a costly path to compliance. 

Shweta Agarwal, PhD
Senior Consultant
+1.207.661.7729

Paula Gray
Managing Consultant
+1.317.272.5425

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