The new EU Medical Device Regulation was pushed back a year. What do you do? We interviewed Sparta Systems project managers for their perspectives.
Q: As of April 2020, EU MDR has been delayed by a year. What does that mean?
A: In light of the COVID-19 pandemic, the European Commission has approved a 1-year delay in the implementation and enforcement of the new European Union Medical Device Regulation.
Q: What new requirements were captured in the EU MDR? Have there been any changes other than the delay?
A: The purpose was to update and tighten regulation of medical devices in the EU. There have been no changes to the MDR as a whole except the Date of Application delay.
Q: Why would the novel coronavirus pandemic have an effect on this regulation rollout?
A: The COVID-19 outbreak and the impact that the resulting response is having several effects that impact this change in timing of the regulation.
- The industry is focused generally on dealing with frontline response to COVID-19, which is of immediate need to alleviate medical product shortages, the lack of diagnostics, and the lack of trusted and qualified therapies.
- The regulatory arm (FDA, EMA and NB) is focused on maintaining a state of control in the industry while acknowledging the immediate need for new and changed medical products and enabling the fast-track evaluation of new treatments.
- Given the restrictions on travel, stay-at-home orders, and the like, the usual paradigm of meeting, planning, and collaborating internally to meet the new requirements, albeit delayed, are also disrupted.
Q: Is the delay for Date of Application (DoA) the only change that impacted MDR project at my site, or is the impact more substantial?
A: The delay was implemented, but COVID-19 impacted MDR projects in other ways as well:
- Resources that had been assigned to MDR preparation have been pulled into other more critical project directly reacting to COVID-19 or have been directly impacted by COVID-19.
- Momentum Loss. Meetings that had been ongoing have been deprioritized, meaning that decisions and actions come slower or not at all.
- Economic ramifications have limited use of, and access to, external resources such as consultancy, software, and other product and service suppliers.
Q: What is important to know about managing current processes that are disrupted?
A: Imperatively, knowledge needs to be preserved. If a project is disrupted but expected to be revived, documenting current state while hibernating the project is critical. Critical data around open tasks and project risks need to be captured and recorded. Include timeline projections for when the situation has passed to aid in resource allocation and optimal manufacturing output.
During the pause or disruption, actively monitor the situation externally to determine the resumption timeline. Factors to consider include resource availability, onboarding, ramp up, and changes in teams.
Q: When the process is revived, how should we work smart through it?
When the workflow is opened back up again, that effort of knowledge capture will smooth the transition. Start with a re-discovery to re-assess scope, resources, and risks and determine or confirm deliverables. Do not assume conditions are the same as before a hibernation period.
- Confirm new current state against any other changes that may have occurred during the hibernation.
- Evaluate the suitability of the original plan (not only milestone dates) with respect scope or resource changes.
- Timelines will be slower in the second project than in the first, due to changes in resources and a need to look back at what was done in the first pass
- Expect the possibility of a decrease in velocity.
- Re-kickoff may be needed, and a workshop format with key stakeholders may be most productive.
- Abide by the project management process.
Prepare for the new European Medical Device Regulation