European Medical Device Regulation (EU MDR)

Streamline your EU MDR strategy with a quality and compliance backbone enabled by digital platforms

Big regulatory changes are coming to the way medical device companies sell their products in the European Union (EU). Previous product management strategies are becoming antiquated and exponentially increasing risk.

As a part of the changes in the EU, Unique Device Identification (UDI) and Basic UDI will be a requirement for medical devices. The new regulatory initiative falls under the EU Medical Device Regulation (MDR) and supersedes the Medical Device Directive (MDD), which previously had no provisions on traceability of medical devices, so the steps necessary for compliance are completely new for organizations selling products in the EU market.

The Deadline Approaches for EU MDR

As deadlines to comply quickly approach in May 2020, we can help you take charge of your regulatory compliance strategy and plan for the new medical device regulatory climate.

Key MDR Initiatives

  • FDA Case for Quality (focus on product quality)
  • Strategically integrate current and planned systems
  • Implement regulatory information Management (RIM)
  • Harmonize UDI processes
  • Consolidate siloed product data systems
  • Augment PLM strategy with IoT and advanced analytics

How we help clients get ready for EU MDR

  • Optimization of existing EU MDR compliance plans/journey
  • EU MDR strategy for process governance, architecture, product rationalization and benchmarking
  • Consolidation, integration and migration of enterprise data
  • Utilization of structure product labeling for content management needs (i.e. clinical trials, technical documentation, labeling, eIFU’s, etc.)
  • Leading practice deployment
    and configuration of PLM
  • Registration of devices and tracking of certificates
  • Digital app connectors, data mashups and advanced analytics, and role-based portals for economic operators
  • Harmonization of Regulatory Information Management (RIM)
  • Submissions of data to the EUDAMED database (i.e. UDI)
  • Clinical investigations
  • Post-market surveillance

Download Our eBook on EU MDR to learn how RIM can accelerate your time to market

EU MDR White Paper

Our Strategic Three-Phase Approach to EU MDR

Kalypso’s hands-on EU MDR experience helps global medical device organizations achieve their compliance goals and deadlines.

The three-phase approach is designed to drive maximum value with an iterative
crawl-walk-run cycle.

  • Perform an EU MDR strategy assessment to identify current state architecture, regulatory initiatives and challenges
  • Review/refine compliance goals, system architecture diagrams, etc.
  • Access key SMEs to capture mission-critical functionality and information
  • Prioritize IT workstreams, software solutions and process governance
  • Implement a small scale proof of value deployment at a subset of operating companies, manufacturing sites and/or products
  • Gain feedback, make refinements and update the PLM/digital system architecture and leading practice
  • Organizational change management (OCM) is essential to driving sustainable results across regulatory organizations
  • Assessment and MVP knowledge is transferred from the first two phases, enabling multiple use cases, while leveraging prioritized software solutions
  • Enterprise-wide business value is realized, and the benefits of an optimized EU MDR program help you streamline your EU MDR journey

EU MDR Solution Overview

At Kalypso, our sweet spot is structuring a consolidated PLM system as the product quality and compliance backbone in support of some key EU MDR work streams:

  • Registration of devices and management of technical documentation
  • EUDAMED UDI database
  • Vigilance and post-market surveillance
  • Clinical investigations
  • Notified bodies and certificates
  • Registration of economic operators
  • eIFU and labeling
  • Material compliance and conflict minerals
  • General Data Protection Regulation (GDPR)

EU MDR Data Landscape & Partnerships

Kalypso and leading life sciences companies are combining the best of both worlds to deliver world-class software implementation and validation support.

Our strategic software partners provide strategy and compliant technology solutions to regulated life sciences companies and make it easy to accelerate transformation and innovation. They focus exclusively on the regulated biotechnology, pharmaceutical and medical device industries and are compliance partners with the world’s top technology platforms and applications.

Eumdr flowchart