April 3, 2020
The coronavirus has had a massive impact on the medical device industry. As a consequence, the European Commission has accepted a proposal to postpone the EU MDR application date. This may be a welcome reprieve to the manufacturers who have delayed EU MDR implementation or are still working through their assessments. Manufacturers have been granted more time to realistically scope your plans for digitization and closing the gaps with legacy products.
Proposal for Delay
A recent announcement from the European Commission stated that in light of the emphasis on patient health and safety, “The Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal was to submit this proposal in early April [2020], so the Parliament and Council can adopt it by the end of May [2020]. This will take the pressure off national authorities, notified bodies, manufacturers, and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.”
The European Commission acted swiftly, and the proposal to delay the EU MDR dates of the application was approved on 03 April 2020.
Many medical device companies welcome this gift of time. During the latter half of the calendar year 2019, many companies I have spoken with shared that they were scrambling to conclude their impact assessments. Many of them admitted their anxiety as they looked ahead to the potential projects that require resources and prioritization. The two most impactful projects will likely be (1) digitizing processes and data sources and/or (2) closing the gap(s) for legacy products that were certified under MDD or registered as a drug before combination product regulations.
Converting to Digitization
Put merely, digitization is the process of converting manual processes and stored information into digital technology for the efficient execution of business processes. Sometimes this can result in modifying or streamlining a business process. Wikipedia defines this as the process of converting information into a digital (computer-readable) format. So, what does this mean to your company?
The known facts about the EU MDR regulations will require companies to implement more efficient, faster, and accurate means to access data. This includes data that resides on paper, locked in file cabinets, or an IT system with restricted access. Factually, EU MDR did not change the device development lifecycle, or the rigor needed to validate the intended use or register the product for market access. However, EU MDR will undoubtedly influence how device design data is stored, how it is retrieved, and how it is maintained.
By now, you are familiar with the records and data that get created throughout the device development lifecycle. Is the data easily accessible? Do you have integrated solutions that enable you to view the data no matter where it resides in your IT ecosystem?
Data from the clinical phase will also be necessary for post-market vigilance and market surveillance as newly introduced in EU MDR. Article 83, Post-market surveillance system of the manufacturer states “for each device manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.” Furthermore, Annex III 1.1b says PMS should include a “PMCF (Post Market Clinical Follow up) plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.”
Now is the time to ask yourself: do you have a PMCF plan and a way to store the plan and the retrieved data through the life of your device? If not already, now is a good time to digitize your PMCF plan and storage of records.
Closing the Gaps of Legacy Products
By now, your company has evaluated legacy products—products that are already approved to be on the market under different regulations like MDD or even as a drug product ahead of the combination product classification. The evaluation and any disposition of identified gaps must be managed as a product change control.
While a manual way of tracking the change might work just fine with few people involved, however, it is much more likely that the legacy device is developed collaboratively with where just about every department has a hand in the development process. Therefore, if developing a product requires a network across a company’s organization, disposition of gaps or post-market product changes should also.
For this reason alone, manual processes must be challenged. Do they offer traceability? Do they offer task management and tracking? Do they enable a cohesive way to document data and record of tasks following ALCOA guidelines? (Attributable, Legible, Contemporaneous, Original, and Accurate.) Though ALCOA originated in the pharmaceutical drug space, the terms represent guiding principles that cut across data governance, regardless of product type. In fact, have you given thought to the fundamental principles that drive EU MDR?
Requiring a lifecycle approach to product management is not a new concept. Also, managing product impact assessments across a company’s organizational network is also not a new concept. Finally, utilizing change management to organize and facilitate the pre-approval and post-approval change…not a new concept. This might sound like a broken record, but these are not new concepts. In fact, pharmaceutical teams are very familiar with the required rigor and have been required to follow it for years.
Hopefully, you have the evaluation documented, any plan of tasks recorded and scheduled, and are ready to begin documenting the evidence of completion. In addition to product design tasks, have you evaluated the product’s PMCF? Do you have a plan and is it current? If not, now is a good time to create one and ensure there is a frequency to review and refresh it. As you’re evaluating your process, consider a system that not only enables the process but automates it, taking the guesswork out of task management and scheduling. Consider a system that enables the integration of key quality and compliance systems, departments, and documentation. Overcome past challenges of siloed and myopic teams with concepts and systems that enable agility and promote integrity.
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