The Medical Device Regulation (EU-MDR) brings a number of significant changes, putting pressure on all impacted parties to closely examine the regulation, assess the impact it will have on their own organization, and implement compliant processes and procedures accordingly.
Since MDR’s release in 2017, many regulatory experts have published and circulated resources aimed at helping companies understand the new rules and adjust their organizations accordingly. While many of these resources are extremely useful, we set out to offer a tangible, step-by-step guide that can be adapted to fit the needs of many companies.
Grab our free white paper, The Complete Guide to EU-MDR Transition to learn how to put this model to use for your organization.
This article offers an excerpt from our white paper focusing specifically on implementing an effective transition program. Contact us today to learn how we can help your organization achieve to MDR compliance.
Read Also: The First Step to Transitioning to EU-MDR Compliance
1. Develop a Governance Structure
This should consist of a primary project manager under the direction of a steering committee. From there, workflows and project-specific teams can be organized to accomplish the specific goals of transition within their respective functional areas.
For most companies, these functional area categories should be Quality, Regulatory, Operations, Supply Chain, Legal, and R&D. These teams will likely be responsible for developing new documentation, creating or revising procedures, and other related tasks—all under the lens of quality management. The specific goals for each team are explained below.
2. Build Your Teams
Once a governance structure is in place, build out your project teams in each functional area with a designated MDR Lead to manage representatives from each area. Identify who will be responsible for certain tasks at the most granular level possible—keeping everything linked to a team leader in charge of oversight. For larger multifaceted companies, this process can take time.
Make sure to leverage all the resources at your disposal and avoid inadvertently putting goals at risk by stretching your teams thin.
General Project Team Responsibilities
- Understand the changes and implications of MDR on their business unit and its function within the broader organization
- Track progress and adapt to pending changes related to EUDAMED, UDI, common specifications, etc.
- Collect current state information to understand the impact of MDR on products, quality system processes, certification status/timelines
- Develop business unit plans for gap assessment, remediation, process changes, and product submission impacts
- Launch newly-developed business unit plans by conducting new activities, producing new deliverables, reporting on status, and escalating issues
3. Write Up Project Charters
The result of your enterprise-wide transition plan should be a number of individual project charters, each following a step-by-step workflow from initial kick-off to confirmation and effectiveness checks. Included in each charter should be a clearly-written definition sheet which lays out goals, project milestones, a timeline, team members, and budget.
The progress of these projects should be controlled by the chief project manager who can relay statuses directly to the steering committee. We’ve highlighted some of the important activities for each business unit below. This is by no means an exhaustive or universally applicable list, but rather a starting point for building out a charter of your own.
Quality Team Activities
- Thoroughly review the current QMS
- Revise QMS processes to take a risk-based approach
- Develop and document processes for managing new and changed requirements
- Conduct computer system validation (CSV) for all impacted software systems
- Upgrade to EN ISO 13485:2016 & MDSAP
- Integrate changes with other QMS requirements in 21 CFR 820
Regulatory Team Activities
- Review product portfolio (as explained above)
- Determine each device’s classification status under MDRDetermine if any invasive cosmetic devices fall under MDR
- Connect with Notified Body to arrange for transition
- Conduct a gap analysis of technical documentation
- Review and update risk management files
- Review and update clinical evaluation reports and related documentation
- Plan clinical equivalence protocols
- Establish systems for regularly reviewing technical documentation
- Establish systems for new post-production PMS, vigilance reporting and PMCF obligations
Operations Team Activities
- Document and plan for current certificate expiry and renewal
- Manage any labeling changes necessary
- Develop a practical plan for implementing UDI
- Identify, prioritize, and manage time-critical operations
Supply Chain Team Activities
- Review the the distributor network
- Review OEM and OBL agreements
- Support Economic Operators with required transactional arrangements
- Manage suppliers’ ENO ISO 13485:2016 certification and transition
Legal Team Activities
- Closely review all possible product liability issues, include OEMs and OBLs
- Examine required insurance requirements
- Establish systems for device complaints processed by third parties
R&D Team Activities
- Carefully set and manage launch dates for new product development according to transition milestones and date of application
4. Develop a Communication Plan and Issue Status Reports
Routine status reports documenting the progress being made on each charter will help the steering committee focus on progress and set priorities as needed, in addition to serving as an aid for communicating project status to senior managers and company leaders.
You should also develop a communication plan for use at the program level as well as in each division and business unit. Make sure to adapt the following messages to their corresponding audiences:
- What is the MDR?
- Why was it released?
- When will it be implemented?
- How will it impact the organization as well as customers, products, and the quality system
- What is the company doing?
- What is needed from the particular audience?
- What measures are in place to ensure issues are escalated and addressed transparently?
- What are the positive outcomes to expect following transition?
5. Conduct Effectiveness Checks and Audits
The result (in terms of tangible output) of each project charter should be verified through individual effectiveness checks on each sub-task within the broader transition program. To supplement this further, conduct a series of audits to identify remaining gaps and fill them ahead of any official inspection.
Performing these, along with a series of mock audits with the help of an experienced third party auditor not only goes further in assessing the new state of compliance, but also prepares staff for the newly-modified Notified Body audits that will bring increased scrutiny in the areas of compliance.
Finally, a management review should be conducted to provide closure on implementation with final confirmation that the transition effective and quality management processes can effectively maintain compliance in the future.
This post is an excerpt from our recent white paper, The Complete Guide to EU-MDR Transition.
Grab our free white paper and get a comprehensive step-by-step guide to building an effective EU-MDR transition program, along with key changes and areas of focus.
