1–3 weeks
Clinical Evidence & PMCF Strategy Review
Whether the clinical evidence supporting a device family will carry an MDR submission and, if not, what remains feasible in the time before the certificate expires.
Evidence cannot be generated retroactively
Clinical evidence developed under MDD cannot simply be assumed sufficient for MDR. Its adequacy must be reassessed against current MDR requirements, current state of the art, the device’s present claims, and its current risk position. Equivalence claims that carried a device for a decade no longer hold unchallenged. PMCF plans written to close a submission frequently never generate usable data, so the next clinical evaluation finds the same gap it found last time, except now there is a documented history of knowing about it.
The constraint is time. A PMCF study that should have started in 2024 cannot be compressed to meet a 2027 date. For a device relying on equivalence with a certificate expiring inside the transition window, the question is no longer how to strengthen the evidence. It is what to do instead. That decision has a closing window of its own.
General Manager or P&L owner
Has to decide between narrowing the indication, funding new evidence, regrouping the family, or discontinuing.
VP Regulatory Affairs
Inherits the clinical position at submission and needs to know whether it will hold.
VP Clinical Affairs
Owns the evidence and the consequence when a Notified Body challenges the equivalence position.
This is the right engagement if
- Your clinical evidence rests on equivalence and you are unsure the position will survive review.
- The clinical evaluation report has not been updated within the cycle your own plan specifies.
- A Notified Body has previously raised deficiencies against the clinical evidence for this family.
- Your PMCF plan exists but the last cycle produced nothing that changed the evaluation.
- You need to know whether new evidence can realistically be generated before the certificate expires.
- You are weighing indication narrowing, regrouping or discontinuation and need the options costed.
What we do
The clinical evaluation is assessed against MDR expectations rather than against a checklist, focusing on whether the evidence supports the claimed indication, not merely whether a report exists. Assessed per claim, not per device.
The equivalence claim, the characteristics demonstrated across clinical, technical and biological domains, and the executed contract granting access to the equivalent device’s technical documentation.
Whether the search could be reproduced by a reviewer, including databases, strings, date ranges, inclusion criteria, screening decisions and appraisal consistency.
Whether the plan is designed to produce data the next clinical evaluation can use, and whether the last cycle produced anything at all.
What each remaining evidence option would take in months and cost, modelled against the certificate expiry date, so that infeasible options are identified as infeasible rather than planned for.
What you receive
Five named outputs. Every finding carries a document reference and revision.
Claim-to-Evidence Map
One row per claim or indication rather than per device, showing the evidence relied on, the source document, a sufficiency verdict, and whether the gap can be closed before the deadline. The common finding is evidence supporting the general indication with nothing supporting two or three specific claims.
Equivalence Position Opinion
A written assessment of whether the equivalence position holds, what would strengthen it, and the consequence if a Notified Body rejects it, including whether any required access agreement exists and covers the data actually relied on.
Evidence Gap Register
Findings across clinical evaluation, literature search, PMCF and post-market linkage, each with a severity rating, the source document, and whether a reviewer would raise it.
Feasibility Model
Each pathway is costed in months and money and tested against the certificate expiry date: maintain, narrow the indication, strengthen the literature, generate new data, regroup the family, or discontinue. Options that cannot report in time are marked infeasible rather than expensive.
Executive Readout
A ninety-minute session answering two questions in the first five minutes: does the evidence hold, and is there time to fix it. The remainder is the pathway decision, with owners and dates named in the room.
How it runs
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Before the clock starts
Document request issued. Where the equivalence strategy relies on another manufacturer’s device and the applicable MDR pathway requires contractual access, the executed access agreement is reviewed at intake. In other equivalence scenarios, the review assesses whether the manufacturer has the level of data access required to substantiate equivalence.
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Week 1
Equivalence basis, applicable access documentation and certificate reviewed on day one. Clinical evaluation plan and report assessed, and the claim-to-evidence map built. Feasibility model constructed. If no evidence option can report before expiry, you are told in week one.
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Week 2
Literature search audited for reproducibility. PMCF plan and evaluation report assessed. Evidence sufficiency confirmed per claim.
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Week 3
Pathways costed and sequenced by feasibility then cost. Report delivered and executive readout held.
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Shorter scope
A one-week screen covers four areas: equivalence position, clinical evaluation currency, literature search reproducibility on a sample, and the feasibility model.
What is not included
- Writing or updating the clinical evaluation report, clinical evaluation plan, PMCF plan or PMCF evaluation report.
- Conducting literature searches, clinical investigations or PMCF studies.
- Technical documentation review outside the clinical sections, or conformity assessment of any kind.
- This review is not a clinical evaluation and does not replace one. Feasibility estimates reflect typical durations for the study types described and depend on factors outside SHOTUNE’s control.
Scope
Evidence Screen
One device family, one week. Four areas, with the feasibility model. The right entry point where the position is in doubt or the clinical evaluation is several years old.
Strategy Review
One device family, three weeks. Full assessment with all five deliverables and costed pathways.
Multi-Family
Two or more families sharing an evidence approach or an equivalent device, delivered sequentially.
Each engagement is confidential and led directly by Dr. Shola Sulaimon. It is fixed-fee, with scope, deliverables, timing and assumptions confirmed in a written statement of work before the engagement begins.
Questions
Our clinical evaluation report is being rewritten. Should we wait?
Yes. Reviewing evidence that is about to change produces findings that can be dismissed as stale. The same applies if a PMCF study reports during the engagement window. It is better to defer and review the completed version.
What if the answer is that we cannot generate the evidence in time?
That is established in week one, and it changes what the engagement is for. The remaining options are narrowing the indication, regrouping the family, or discontinuing. These are all commercial decisions rather than clinical ones. They are costed and sequenced so the choice can be made on numbers rather than on preference, which is why the person who can authorise that decision should attend the readout.
What happens if required documents or access arrive late?
The delivery date moves accordingly. The engagement timeline assumes the agreed documents, data and access are available when intake closes. If required inputs arrive late, SHOTUNE will confirm the revised delivery date rather than compress the review.
Start with a confidential strategy discussion
Thirty minutes. We will start with the evidence position, the certificate timing, what is changing, and who needs to make the pathway decision. If this is not the right engagement, you will be told plainly.