1–4 weeks
EU MDR Renewal & Notified Body Readiness Review
A structured review of a technical documentation package before it reaches the Notified Body to determine whether it will survive review and whether the timeline closes before the certificate expires.
The deficiency round you did not plan for
Technical files written to MDD standard do not survive MDR review unchanged. Evidence that was sufficient in 2016 is not sufficient now, and the gaps surface at Notified Body review after the queue slot has been consumed and the clock has run.
Notified Body review commonly runs eighteen to twenty-four months, on top of six to twelve months of file preparation. For devices relying on the applicable MDR transitional provisions, the relevant compliance deadline may be 31 December 2027 for Class III and applicable implantable Class IIb devices, or 31 December 2028 for remaining applicable Class IIb, Class IIa and relevant Class I devices. Certificate expiry and the applicable MDR transition deadline are not the same thing, and a single unplanned deficiency round can materially reduce the remaining submission and decision window.
CEO or Business Unit Leader
Needs to know whether the submission path protects market continuity, whether the timeline still closes, and what leadership decision is required if it does not.
VP Clinical Affairs
Owns the evidence half of the file, the seam where regulatory and clinical either coordinate or fail separately.
VP Regulatory Affairs or VP Quality
Owns the submission or quality-system readiness that can determine whether avoidable findings push the review beyond the available window.
This is the right engagement if
- A submission is being prepared against an applicable MDR transition or compliance deadline of 31 December 2027 or 31 December 2028, depending on the device cohort.
- The technical file was built under MDD and has not been independently assessed against MDR expectations.
- Your clinical evidence rests on equivalence and you are unsure the position will hold.
- A previous submission attracted deficiencies and you want the next one tested first.
- You need to know whether the current submission date closes before the applicable MDR transition deadline or another certificate timing constraint.
- The design is frozen and the package is close to final.
What we do
Full technical documentation assessment against Annex II and Annex III structure, including GSPR matrix traceability, clinical evaluation report, risk management file and post-market documentation. Cited evidence is sample-verified, not accepted at face value.
Identification of the specific findings a reviewer is most likely to raise, ranked by likelihood and by schedule impact if raised, informed where available by the deficiencies your Notified Body has raised before.
Reconciliation of submission date, realistic review duration, expected deficiency rounds and certificate expiry, to determine whether the current plan closes.
What must be corrected before submission, what can be addressed in a deficiency response, and what can be deferred.
What you receive
Five named outputs. Every finding carries a document number and revision.
Submission Timeline Model
A dated model reconciling submission date, review duration, expected deficiency rounds and certificate expiry, showing whether the plan closes and by what margin. Where it does not, it states the latest submission date that would. This is delivered in week one, not at the end.
Readiness Report
Written findings by document section, each with a severity rating, the rationale, the source document and revision, and the required action.
Deficiency Risk Register
A ranked list of the questions a reviewer is most likely to raise, with likelihood, schedule impact if raised, the basis for the prediction, and how each could be pre-empted before filing.
Remediation Sequence
An ordered work list with owners, effort estimates and dates, separating what must be corrected before submission from what can be handled in a deficiency response and what can be deferred. Knowing what does not need fixing saves as much time as knowing what does.
Executive Readout
A ninety-minute session opening with whether the timeline closes, then the findings carrying schedule impact, then the decisions required with owners and dates named in the room.
How it runs
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Before the clock starts
Document request issued, mapped to Annex II and Annex III section by section so your existing file can be matched against it directly. The version intended for submission is required, with a document control list.
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Week 1
Package inventory and document control reconciliation. Prior Notified Body correspondence read first. Timeline model built and the Article 120 position verified from the executed agreement. If the timeline does not close, you are told in week one.
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Week 2
GSPR matrix worked row by row with cited evidence sample-verified. Risk management file assessed against ISO 14971:2019 and the MDR benefit-risk standard. Design verification and validation checked against the configuration being submitted.
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Week 3
Clinical evaluation assessed for sufficiency against the claimed indication. Literature search tested for reproducibility. Annex III post-market documentation reviewed. Deficiency register completed and ranked.
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Week 4
Report delivery and executive readout with the decision set.
What is not included
- Writing or remediating technical documentation. The review identifies what must be corrected and by when; execution sits with your team.
- Preparing or filing the submission, or corresponding with the Notified Body on your behalf as part of this engagement.
- Conducting clinical investigations, literature searches or PMCF studies. Where evidence generation is required, the review states what is needed and the realistic timeline for it.
- This review does not constitute regulatory approval and does not bind any Notified Body.
Scope
Deficiency Screen
One device family, one week. The four sections that generate the most deficiency rounds, plus the timeline model. The right entry point where the timeline is in doubt or the file has never been assessed against MDR expectations.
Submission Readiness Review
One device family, four weeks. Full Annex II and Annex III review with all five deliverables.
Multi-Family
Two or more families, delivered sequentially, highest-exposure family first. Findings from the first routinely apply to the rest.
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 design verification reports are still in draft. Should we wait?
Yes. If verification and validation are not final, the design is not frozen and the package will change after review, which means findings can be dismissed as stale. It is better to delay the engagement than to review a moving target, and that will be said plainly during the initial consultation.
What if the review finds the timeline does not close?
You are told in week one rather than week four. At that point the question is no longer package quality. It is whether to restructure the device grouping, narrow the submission, or discontinue. That is a commercial decision, and the engagement is re-scoped around it rather than continuing as planned.
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 submission, the deadline, the condition of the package, and who has to make the decision. If this is not the right engagement, you will be told plainly.