Supporting an MDD to MDR transition
Outsourcing EU MDR to allow internal resources to remain focussed on New Product Introduction (NPI)
A leading global company offering medical technology, services, and solutions engaged CLIN-r+ to help its ‘Patient Monitoring’ business unit prepare for the EU Medical Device Regulation (MDR). Specifically, CLIN-r+ provided the strategy to transition the MDD technical files and build compliant MDR technical documentation files for submission.
The manufacturer identified the risk of losing focus in New Product Introduction (NPI). Product activities needed to maintain their current growth in international markets if internal resources were fully deployed to meet the EU MDR transition needs. The Clinical Evaluations and Investigations workflow also needed further expertise and would take away time from critical resource areas such as Clinical Affairs, Clinical Trials management and medical writing.
The Challenge
CLIN-r+ was appointed to deliver EU MDR solutions on a managed outsourced basis. The manufacturer wanted a partner who could take the heavy burden of creating the first version of their MDR Technical Documents (especially the Clinical Evaluation) that the file is more manageable for their internal team to maintain. They also wanted systems in place to automate the updates of post market surveillance and review of the benefit-risk impact of new data.
The client had already carried out their own gap assessments so CLIN-r+ was able to identify and deliver an action plan from day one. From its portfolio of EU MDR compliance solutions, CLIN-r+ assisted with risk management, post-market surveillance remediation, clinical evaluation, and technical writing of the MDR Technical Document.
The manufacturer appointed an internal project manager to follow-up on internal documents and CLIN-r+ deployed an expert team, tailored to the client’s requirements, with experience across diverse areas, including quality engineering, risk management, biocompatibility, clinical evaluation, and quality system compliance.
We found the expected shortfalls under EU MDD in the MDD Technical Files during the project discovery stage. An EU MDR gap assessment showed:
- No Clinical Development Plan.
- No State of the Art (SoTA).
- No Clinical Investigation SOP and templates (PMCF Plan, Clinical Investigation Plan, etc.)
- Remediation of the Clinical Evaluation SOP and templates to show compliance with MEDDEV 2.7.1rev4, IMDRF guidance and MDCG guidance.
- The PMS process and documents needed alignment as per EU MDR Article 120 (transition period) and requirements for trend analysis.
- No PMCF plan and post market data needed in some files.
- The client needed remediation to comply with:
- Technical Documentation needs in MDR Annex II – Risk Management and PMS.
- MDR classification, GSPR and conformity route.
- Post Market Surveillance process.
- Benefit-risk review required integration.
The CLIN-r+ Solution
CLIN-r+ enabled collaboration and transparency through the rapid creation of virtual collaborative space within the clients existing intranet. This ensured IP and insights remained safeguarded behind the clients IT infrastructure.
CLIN-r+ partnered with the client on EU MDR preparedness. We remained flexible, focused, and applied specialised skills in order to keep them on track. The client’s goal was to ensure that the required products were EU MDR ready, well ahead of the recertification dates.
CLIN-r+ reacted to the needs of the organisation for the additional services the client required as the project progressed. We started off supporting the client in Risk Management File remediation. However, this quickly expanded into several areas where there were internal resource constraints and skills gaps.
The review of the client’s gap assessment by CLIN-r+ identified further efficiencies and higher level strategic alignment of terminology for EU MDR. This would benefit multiple products and provide alignment throughout the project. CLIN-r+ provided a timebound project plan with matching deliverables to meet the deadline for EU MDR submission as agreed with the Notified Body.
On this project, we agreed that CLIN-r+ would streamline and deliver EU MDR solutions on a managed outsourced basis. In order to do this, we:
- Reduced the management burden of the project (internal staff were already at high capacity) by providing a full capacity MDR consultant and Clinical Affairs team (SLR reviewers, Medical Writers, Medical KOLs, Biostatisticians and Clinical Trial Designers) to hit the ground running.
- Held an on-site workshop to review each gap and describe the expected remediation path and deliverables.
- Worked in partnership with client subject matter experts (SMEs) and process owners to address issues and approve deliverables.
- Reviewed documentation of objective evidence and updated risk, clinical and post market documents.
- Conducted impact assessments of changes to standards to ensure compliance to state of the art (SOTA) requirements.
- Provided an EU MDR alignment document known as a ‘Device Summary’. We ensured terminology, classification and GSPRs were aligned to ensure the CER was fast tracked, agreed and signed off by manufacturer leadership.
- Provided live, accurate and transparent measurement of progress. Developed a portal (within 1 week) to facilitate remote and group collaboration. All team members accessed the project plan and deliverables in real time and IP was maintained on the manufacturer’s portal.
- Provided Clinical Evaluation strategy as the Clinical Evaluation Plan and Clinical Development Plan.
- 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
Under EU MDD, the system had multiple Technical Files within the same product family which often created duplication in effort and validation work. We advised on consolidated product family Technical Documentation. The ‘Intended Purpose’ of the devices was aligned but terminology in the product descriptions needed alignment with EU MDR.
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 MDD technical files to new MDR technical documentation templates and 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. The client had transparency on progress and a point of collaboration so that multiple sites and department inputs could 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.
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 completed Clinical Development Plan and Clinical Evaluation Plan. As well as drafted position papers to provide missing rationales and summarise evidence collected in support of new requirements.
Signed out and handed over the management of the process 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.
- 47% 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 EU MDD to one MDR product family significantly reduced the cost, resources, and time to compile EU MDR Technical Documentation.
- Delivery of Technical Documentation within 8 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.
- Met the requirements of Article 120 to be eligible for the EU MDR transition extension if it was needed or if the audit was prolonged.
- 4 months ahead of schedule to complete the Technical Documentation for EU MDR submission.
- 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!
