Fast Tracked PMCF Activities
Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence
An innovative Australian MedTech offering Incision Management solutions engaged CLIN-r+ to support its Regulatory Department close off a mayor non-conformity which was also impacting their EU MDR transition. Specifically, CLIN-r+ was tasked to help overcome the lack of clinical data due to no PMCF activities being undertaken after their Class IIa device obtained a MDD certificate using the equivalence route.
The manufacturer identified the risk that their Post Market Surveillance activities was inadequate. They also had no previous experience in conducting post market clinical studies in Europe. As such the client appointed CLIN-r+ to remediate their PMS activities. The purpose being to close off the QMS audit, meet the Article 120 requirements to secure EU MDR extension, and fast track clinical data acquisition so that they could be ready for their EU MDR readiness audit within 6 months.
The Challenge
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 manufacturer appointed CLIN-r+ to close-off the non-conformance findings, secure the EU MDR extension by updating their current PMS workstream and provide a PMCF plan to meet the data requirements for an EU MDR Technical Document.
The manufacturer needed clarity on the amount of work and resources required from the business unit. The company needed the clinical data within 6 months to meet their EU MDR readiness audit. The client initiated the project through an EU MDR gap assessment. CLIN-r+ conducted a thorough review of the MDD Technical file and QMS procedures.
The CLIN-r+ Solution
The review of the client’s gap assessment by CLIN-r+ identified further efficiencies. We designed our gap assessment to not only close off the non-conformities but to highlight the gaps in EU MDR submission. Beyond the provision of a PMCF Plan, the manufacturer needed to remediate processes to meet Article 120 and EU MDR needs. This was highlighted as a risk as the manufacturer was eligible for EU MDR transition extension and they could have potentially had to stop selling in Europe prematurely whilst they were awaiting EU MDR certificate.
CLIN-r+ provided a timebound project plan with matching deliverables to meet the deadline for the EU MDR readiness audit. In order to do this, we:
- Provided a gap assessment and EU MDR project plan.
- 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.
- Developed a global approach for the implementation across 3 continents.
- Remediated Post Market Surveillance, Clinical Evaluation, Risk Management and Clinical Investigation SOPs and templates.
- 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’ that 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.
We delivered an updated Clinical Evaluation Report, Post Market Clinical Follow-up plan, Clinical Investigation plan and contracting to CRO and PMCF Report. 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.
We provided a live project plan dashboard. This gave transparency on progress and a point of collaboration so that multiple sites and department inputs were 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.
CLIN-r+ formulated and provided an EU MDR QMS process remediation of the following workstreams:
- PMS workflow.
- Clinical Evaluation workflow.
- Risk management workflow.
- Clinical Investigation workflow.
CLIN-r+ provided specific Clinical Investigation SOPs and EU MDR compliant templates.
We signed out and handed 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:
- Delivery of a PMCF Plan, Clinical Investigation Plan (CIP – trial design and statistical analysis) and CRO execution that reduced 80% of costs of an initial CRO quote.
- Delivery of PMCF Plan (including CIP) within 1 month that conforms to ISO 14155.
- Delivery of PMCF Report within 1 week of receiving the Clinical Investigation Report.
- Delivery of The Clinical Evaluation Report within 4 weeks of the PMCF Report.
- No findings on the MDR Readiness Audit.
- Successful EU MDR transition with CE mark within an ambitious European launch date.
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!
