Supporting an FDA 510k to MDR transition
Manufacturers journey to enter the European market by leveraging their FDA 510k certificate
A leading American company offering guidewires and catheters engaged CLIN-r+ to help its ‘Vascular Access’ business unit prepare to enter the European market. Specifically, the manufacturer asked CLIN-r+ to provide the strategy to translate their FDA 510k file to EU MDR Technical Document for CE marking submission.
Because they were experienced with the FDA process, notably the 510k significant equivalence route, the US company prioritised entering the US market. The manufacturer’s European office was growing frustrated as European surgeons were requesting the device and it seemed they were losing ground against competitors, missing key moments with Key Opinion Leaders and missing opportunities in market access tenders.
The manufacturer identified the products as EU MDR Class III devices without having any European regulatory experience. They identified the significant cost of submitting an EU MDR application and the need to enter the market for significant investment in their expansion strategy. As such the client appointed CLIN-r+ to manage several EU MDR workstreams and to prepare regulatory submission documents for EU MDR leveraging their 510k files.
The Challenge and the Impact
The manufacturer needed clarity on the amount of work and resources required from the business unit. CLIN-r+ knows that for accessibility and collaboration, we need to be on a live virtual platform. We delivered this within 48 hours with a centralised project plan to keep stakeholders informed.
The client initiated the project through an EU MDR gap assessment. CLIN-r+ was able to conduct a thorough review of the 510k files of all the products to clarify the gaps. The client asked for an FDA 510k to EU MDR translation service. This included CLIN-r+ providing the translation strategy, EU MDR project plan, support of validation workstreams and delivery of the EU MDR Technical Documentation.
They appointed CLIN-r+ to deliver EU MDR solutions on a set project plan and payment of milestones basis. We facilitated further out of scope services with a managed service agreement.
The CLIN-r+ Solution
CLIN-r+ partnered with the client on EU MDR preparedness by remaining flexible, focused, and applying specialized skills in order to keep them on track. The client wanted to ensure the products were EU MDR-ready before the planned European launch.
We enabled collaboration and transparency through the rapid creation of virtual collaborative space within the clients existing intranet. This ensured IP and insights remain safeguarded behind the clients IT infrastructure.
CLIN-r+ also reacted to the needs of the organisation for the additional services the client required as the project progressed. We supported the client in compiling the Technical Documentation and quickly expanded into several areas where there were internal resource constraints and skills gaps.
Our gap assessment has been designed to not only find gaps in EU MDR conformity, but also highlight opportunities to consolidate individual products under a product family and deliver a document process system to make regulatory maintenance manageable for new regulatory professionals.
Multiple product files in the same product family had created duplication and validation work in the 510K system. We advised on a consolidated product family EU MDR Technical Document as a high-level strategy. The clients Notified Body accepted this.
CLIN-r+ provided a timebound project plan with matching deliverables to meet the deadline for the EU MDR readiness audit and European launch deadlines.
On this project, we agreed that CLIN-r+ would undertake and internally streamline the delivery of the 510k to EU MDR Technical Documentation translation. In order to do this, we:
- Provided a full Regulatory, Technical and Clinical Affairs team to prepare all necessary technical and coordinated supporting documentation with the internal project manager in order to provide a smooth pathway to regulatory submission.
- Provided a gap assessment and EU MDR project plan.
- Held a workshop to review each gap and describe the expected remediation path and deliverables.
- Provided live, accurate and transparent measurement of progress. Developed a portal (within 1 week) to facilitate remote and group collaboration where the project plan and deliverables were accessed in real time by all team members and IP was maintained on the manufacturer’s portal.
- Provided product specific and formatted MDR compliant templates. These made up the Technical Documentation true to the clients brand identity and ensured all inputs were consistent.
- Identified 510k documents for use with the EU MDR submission, overlapped validations between product family devices and executed the remediation actions.
- Identified missing GSPR validation requirements and started external contract testing to avoid delays to workstreams.
- Identified ‘product’ families’ to reduce the Technical Documentation submission and maintenance burdens.
- Provided an EU MDR alignment document known as a ‘Device Summary’. This ensured alignment of terminology, classification and GSPRs, so that documents were fast tracked, agreed and signed off by document owners.
- Worked in partnership with client subject matter experts (SMEs) and process owners to address issues and approve deliverables.
- Conducted impact assessments of changes to standards to ensure compliance to state of the art (SOTA) requirements.
- Provided validation strategies and reviewed contract testing houses validation plans and reports with internal SMEs to provide knowledge transfer.
- Project managed the project plan board with deadlines and reminders to stakeholders to ensure timely inputs for sign-off to deadlines.
- Managed weekly huddles to ensure all team members were updated and motivated to deliver on time.
The Deliverables
CLIN-r+ conducted a ‘Kick-Off’ phase to align the project with the overall strategy. This was signed off and executed in the ‘Device Summary’. This forms the basis of the files within the Technical Documentation workstreams. We also used this phase to ensure that all stakeholders were on the same page throughout the project.
CLIN-r+ mitigated legacy data from 510k files to new MDR technical documentation templates. We also gathered pertinent data from across the MDR workstreams to update the documentation. The manufacturer received files for the device Technical Documentation that were created, approved, and signed off by suitably qualified medical experts to meet the requirements of EU MDR, IMDRF, MDCG guidance, ISO standards, and MEDDEV 4.7.1rev4.
We ran weekly huddles which provided the team with support and momentum to focus on key deliverables. It allowed us to provide Clinical Regulatory support and fast track on workflows that the internal team were not confident to progress.
CLIN-r+ provided a live project plan dashboard. This gave transparency on progress and a point of collaboration for multiple sites and department inputs to be centralised in one area. This also provided live updates to executives on the project progress with restricted access to year to date (YTD) progress and YTD project budget.
We provided consistent and clear communications via the dashboard that included:
- A remediation log and tracking tool documenting assignments, activities, and project status.
- Executive summaries of key issues identified during gap assessments of each product.
- Weekly summary status reports of completed and upcoming activity.
- Core team and governance board meetings during the remediation stage to discuss risks, issues, and escalations.
CLIN-r+ provided drafts of the position papers to provide missing rationales and summarise evidence collected in support of new requirements.
We signed out and handed the process management to the internal team, with ease of access for CLIN-r+ to carry out periodic updates.
The Benefits
The manufacturer had received all deliverables in the specified amount of time and in keeping with the CLIN-r+ proposal budget. Above the deliverables the project had a few noticeable benefits:
- All risk on overstretching internal resources was mitigated and work as usual continued during the EU MDR transition project.
- 27% reduction in cost of EU MDR projected transition spend from the initial internal estimates versus the CLIN-r+ proposal.
- Consolidated multiple individual product files under 510k to one MDR product family significantly reduced the cost, resources, and time to compile EU MDR Technical Documentation.
- Delivery of Technical Documentation within 9 months from start to execution phase.
- All changes order completed with no findings on the MDR Readiness Audit.
- Successful award of an earlier EU MDR submission date by the Notified Body during the MDR readiness audit.
- Successful EU MDR transition with CE mark 12 months ahead of schedule.
By partnering with CLIN-r+, our clients are able to proactively implement their strategic goals well in advance of deadlines. We keep the project on track and ensure each gap has been closed, providing the support you need, where you need it.
Should you have any questions or need professional assistance, CLIN-r+ has a wealth of experience to call upon. Get in touch!
510k vs MDR FAQ
Translating your FDA 510K to an EU MDR submission
