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Countdown to 2020: Meeting the EU MDR Requirements

​In May 2020, the European Medical Device Regulation (EU MDR) will be in full force, bringing with it higher scrutiny and relevance of clinical data, increased transparency and documentation requirements, greater responsibility within the supply chain, increased time to market and added importance for product portfolio rationalization. Not surprisingly, the regulation touches virtually every part of our business — from marketing to clinical affairs, quality to supply chain, regulatory to operations, legal to logistics, and more (see EU MDR Business Impacts sidebar). Ensuring our products are EU MDR compliant is critical for maintaining our CE marking and continuing to do business in the European market. To tackle this challenge, we have established the BlueStar Project — a cross-functional, multi-year effort with the purpose of assuring we have the systems and processes in place to meet the EU MDR May 2020 implementation date.

 

Studying the Supply Chain

One of the important differences between the new EU MDR and the Medical Device Directive (MDD) it replaces, is the new supply chain requirements. Becoming compliant under the EU MDR requires us to examine the entire supply chain leading into the European Union (EU), identifying each entity involved in getting a device to the end user. These "economic operators," include importers and distributors that now have increased responsibility and liability within the supply chain (Figure 1).

 

This new system of checks and balances requires each economic operator to independently verify that the previous economic operator has complied with the EU MDR requirements. This is true even for different entities within Terumo BCT and requires a shift in how we think about our own supply chain. To address this, the BlueStar Project team has begun mapping all economic operators within the supply chain to understand what agreements, processes and standard operating procedures (SOPs) may need to be updated

 

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Figure 1: The EU MDR requires all economic operators within the supply chain to ensure the previous economic operator has complied with the EU MDR requirements

 

EMEA Distributor Role

As discussed at the Team Ready meeting in 2019, our EMEA distributors are a critical part of our supply chain and now have increased responsibility, which includes:

  • Verify the device has been CE marked and that Terumo BCT products have a declaration of conformity.
  • Verify the device is accompanied by instructions for use (IFUs), operators manuals and labels.
  • Verify a unique device identifier (UDI) has been assigned.
  • Ensure safe storage and transport conditions, based on the product requirements.
  • Register distributor entity into the national distributor database.
  • Cooperate with the competent authorities.

The BlueStar Project team is actively working with EMEA distributors to understand their EU MDR readiness and to help implement any changes required as part of the new regulation.


Responsibilities of Distributors Outside EMEA

If you aren't located in the EU, there are still implications you should be aware of. The CE mark is recognized in more than 90 countries worldwide, so we anticipate that countries outside the EU will start reacting to EU MDR and put new processes in place. We ask that you stay vigilant monitoring market dynamics and report any Ministry of Health (MoH) changes to your Terumo BCT representative.

We still have a lot of ground to cover before we can say we've reached 100 percent implementation of the EU MDR. However, the BlueStar Project is making excellent progress and its teams are confident the project will remain on schedule. You can do your part by reading the official text if you haven't already and proactively begin examining your own internal processes and SOPs to help prepare for compliance. If you have any questions, please contact your Terumo BCT representative.

 

SIDEBAR: EU MDR Business Impacts

  1. Improved traceability of medical devices (UDI)

    MDR is implementing a unique device identifier (UDI) system similar to what is used in the United States. Product related data will need to be uploaded to the European Database on Medical Devices (EUDAMED). UDI workflows and technology support must be updated accordingly to meet new requirements.
  2. Expanded labeling requirements

    Expanded labeling requirements will require updates to all equipment and disposable labels, operators manuals and IFUs. New language requirements may favor a more localized (versus centralized) labeling supply chain.
  3. Updated classification rules

    There have been changes in the classification rules and we expect that many of our products will be impacted and potentially receive up-classification.
  4. Stricter requirements for clinical evidence

    In the past, using clinical justifications based on a competitor's device equivalence was standard practice. Under MDR, equivalence will be less accepted, particularly for devices considered high-risk such as Class III or implantable devices. Additional clinical evidence may be required to support safety and performance. 
  5. Increased requirements for post market surveillance (PMS)

    Emphasis is being shifted to proactive PMS approaches rather than relying on reactive systems, such as complaints monitoring. There is a shift to a life-cycle approach and Terumo BCT will need to implement a more comprehensive set of proactive PMS data collection methods.
  6. Greater responsibility and liability for economic operators

    While the legal manufacturer had the majority of regulatory responsibility under the MDD, the importer, distributor and authorized representative now have increased responsibility and liability to maintain compliance. Terumo BCT must look closely at the supply chain leading into the EU and identify each entity up to the end user.
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