Some sample changes and considerations are…
Re-classify devices (as needed); assess impact on revenues and margins
QMS Impacts; increased Notified Body powers; key Regulatory resource accountable
Enhanced traceability; UDI system; assess impacts to suppliers
Enhanced post-market surveillance and vigilance processes
Change in label requirements, instructions for use requirements, and impacts to packaging
Clinical Evaluation/Investigation – expanded clinical evidence regarding safety and efficacy
EUDAMED database alignment and IT changes to meet EU MDR regulations
The first phase of the EU MDR is required to be in effect by May 2020 — are you ready?
Do you have the structure?
- Is your EU MDR effort structured and organized?
- Do you have clear awareness of project progress and timelines?
- Have you defined “done” for your organization’s EU MDR efforts?
Do you have the expertise?
- Do you understand how the EU MDR will impact your business?
- Have you defined the Quality System and Clinical impacts?
- Have you completed the device remediation activities per EU MDR?
Do you have the people?
- Do your people have the bandwidth to drive this effort?
- Have you identified a central decision-maker or panel of decision-makers?
- Are you missing milestones due to lack of personnel?
Praxis can help
We can build the structure
- We created a PMO structure to successfully drive an eight-month EU MDR, Phase I effort
- We defined done for the effort, developed project plans for each workstream, drove project progress, and kept all of the teams closely aligned
We have the expertise
- We have successfully and efficiently driven our client through all of these activities and are currently awaiting to complete the notified body audit (upon their certification)
- We have built quality docs and updated medical device manuals
We have the people
- We bring project managers who are versed in EU MDR, core project management leadership, medical devices, and Quality/Regulatory principles
- We have subject matter experts with deep, cross-functional knowledge
We have found that some clients have resisted or struggled with implementation — we can help you overcome these barriers
Project planning is challenging
Analysis paralysis of current state
Poor resource availability
Proposed changes could be costly
Not sure how to prioritize
Activities constantly delayed
Will not accept reality
We can provide support/expertise across a few different models
|Conduct project planning/current state |
assessment to shape strategy
|Drive PMO Effort to oversee delivery of |
each workstream (includes ongoing comms
and governance design)
|Provide resources to drive delivery of |
all or the prioritized workstreams