How the delay of MDR (2017/745) gives an opportunity to focus on strategic transformation

by James Moore - Consultancy Director - Data & Analytics
| minutes read

With the recent challenges caused by the COVID-19 pandemic, it is natural, positive and constructive to revisit and reflect on what is key and important. As the European Commission postpones the enforcement of the upcoming Medical Device Regulation (2017/745), Medical Device Manufacturers now have the opportunity to support the fight against the global pandemic while focusing on their overall strategy and optimised transformation of their business.

From some very recent discussions with my clients and colleagues, two strategic imperatives stand out as core and critical during and after the crisis, as they were before:

  • Agility and flexibility in how to conduct and execute on internal and external processes.

  • Drive to digitalisation. Embracing the online capabilities (technologies and techniques) and the evolving, enhanced and augmented experience for customers, colleagues, partners and wider society as they interact with one another more and more virtually.

These are not new vehicles of change and the merits in how they help realise successful transformation strategies are well established and stated elsewhere. What strikes me is they are arguably even more important, relevant and key for an organisation now to survive and thrive in current climates and how reliant they are on the ability to access the data which underpins every interaction, every transaction and every decision they undertake.

Data is the key to becoming the agile digital enterprise

Access to timely, relevant and valid data which can be acted upon is crucial. Even more so, as decisions and actions become automated, as the customer (client, citizen or patient) is demanding a more tailored, relevant experience and the regulator is more intrusive, seeking evidence based assurance for compliance. All are reliant on the data, it’s quality and coverage, and how effective the provision of it is.

This data provision is best managed through a centralised Data and Analytics platform acting as a single relevant source of product performance data overcoming the existing silos in the enterprise with a catalogue based hub and spoke solution.

The Data and Analytics platform should intelligently ingest a hugely diverse set of structured and unstructured data. Sorts and filters based on the data content, context and relevance to business users and outcomes.

This platform optimises by continuously learning and adapts to apply intuitive tagging and categorisation for ‘google’ like simple text search retrieval. Unifying and enabling the silos across the organisation with an holistic, timely and relevant data set.

A strategic Data and Analytics Platform offers value significantly beyond regulatory compliance

This trusted, secure, available and complete data source can empower across the business with the ability to adapt to an ever changing environment, be it to:

Enhance patient safety with

  • Proactive identification of risks
  • Live trend analysis and alerts
  • A data record for full product lifespan

Make informed evidence based decisions within

  • Portfolio and Inventory Management (PMS), determining the market’s need based on what is being requested rather than relying on an outdated product catalogue
  • Product research and development conducted with full understanding of customer feedback (Post Market Surveillance), faults investigated, mapped to actual cases, recalls and clinical evaluation
  • Better propositions and product flexibility with side by side product comparison, compatibility and substitution

Drive Sales

  • Better Product Data to enable sales with potential to introduce dynamic pricing
  • Improve ROI with streamlined product design, manufacturing and supply
  • Increase success in tenders with integrated and joined up management and use of product data and processes

Supply Chain

  • Inventory catalogue consistent, available across all points and parties in the chain
  • Just in time ordering with a joined up ecosystem based on common (or mapped) product catalogue taxonomy
  • Logistics adaption to incorporate changes in the ecosystem, protecting downstream to impacts when suppliers or logistics change

Compliant ready (always)

  • MEDDEV REV4 and MDR compliance
  • Remain Audit ready with better data available now to generate accurate reports
  • Time of highly qualified staff freed up to drive product development, client and customer experience

With these potential benefits, now is the time for change.

Enhancing and investing into your existing data and analytics platform would help facilitate the change required for the Medical Device Regulation (2017/745) coming into force in May 2021. However it does more, much, much more.

It can be the catalyst, enabler and driver for your full transformation. Building in the resilience to respond as crisis hits and the flexibility and scalability to act rapidly and decisively as opportunities present themselves. To become the agile digital enterprise supporting and empowering all areas of the supply chain and wider ecosystem to excel and thrive. Not just survive.

More Information

Our Medical Device Manufacturing team at Sopra Steria have real world expertise of guiding organisations through the MDR journey, equipping the business with an effective, data driven solution to facilitate regulatory compliance whilst reducing the reporting burden associated with this type of legislation.



For more information on Sopra Steria compliance solutions for MDR please contact:

James Moore

Consultancy Director – Data and Analytics