Sequential, single-threaded review
Sending the asset to Medical, then Regulatory, then Legal in series multiplies cycle time and lets each function comment without seeing the others. Run the three in parallel against a shared brief.
Resources
Setting up an efficient MLR review process for medical devices
A practical guide for Marketing, Marcomms, Regulatory, Medical and Legal leaders. Structure the medical legal regulatory review so campaigns ship on time, with fewer rounds and a clean audit trail.
EU MDR, IVDR and FDA aware
Built for medical devices, not pharma
What an efficient MLR review process actually looks like
The medical legal regulatory review process is where most medical device marketing assets lose weeks. Six, eight, ten review rounds, conflicting feedback between Regulatory and Legal, late evidence requests and a campaign that misses its window. Almost all of it is structural, not personal.
This guide is for Marcomms leaders, Regulatory chairs and Marketing operations owners who want to redesign the workflow so it produces approved, defensible copy in two rounds instead of eight. It complements the Medical Device MLR Submission Checklist (what to check on each asset) and the MLR Terminology Guide (the shared vocabulary).
The frame is simple: a clear brief, a structured pre-check, a parallel functional review, a named reconciliation chair, a locked archive, and a feedback loop into post-market surveillance. Everything else is local detail.
The six stages of an efficient MLR review process
A workflow that scales from a single product launch to a multi-market portfolio.
1. Brief and intent
Owner: MarketingOutput: Asset brief, claim list, evidence packMarketing or Marcomms opens the cycle with a one-page brief covering audience, channel, deadline and the claims the asset depends on. Each standalone claim is mapped to an evidence source: clinical evaluation report, bench data, published study, technical file section or post-market surveillance summary. No evidence, no claim.
2. Pre-check
Owner: Marketing ownerOutput: Cleaned draft, flagged risks, reviewer noteBefore the asset ever enters formal review, the Marketing owner runs a structured pre-check on every claim against the device's cleared or CE-marked intended purpose, IFU and the rules that apply in each target market. Obvious off-label language, unsupported superiority claims and missing regulatory marks are fixed here, not in round four.
3. Parallel functional review
Owner: Medical, Regulatory, LegalOutput: Consolidated comments in one documentMedical, Regulatory and Legal review in parallel, not in sequence, against a shared rubric. Each function works from the same brief and evidence pack and posts comments into one consolidated document. Parallel review is the single biggest lever for cutting cycle time.
4. Reconciliation
Owner: Marketing owner + chairOutput: Decisions log, revised draftA named chair, usually Regulatory, reconciles conflicting comments in a short working session. Decisions are logged with a rationale so the same point is not relitigated on the next asset. Marketing applies the agreed changes in a single edit pass.
5. Final approval and lock
Owner: RegulatoryOutput: Approved asset, archived evidence packRegulatory signs off on the locked version. The asset, the evidence pack, the claim mapping and the decisions log are archived together. The archive is the audit trail and the seed for the next campaign.
6. Post-launch monitoring
Owner: Regulatory + MedicalOutput: PMS-aware claim registerLive claims feed back into the post-market surveillance and clinical evaluation cycle. If real world evidence shifts, the claim register is updated and any in-flight assets are flagged. The review process is a loop, not a one-shot pipeline.
Roles and responsibilities across the four functions
A clean split of ownership stops Marketing waiting on the wrong function for the wrong question.
Marketing / Marcomms
Owns the asset, the brief and the evidence pack
- Writes a clear, channel-specific brief with audience, claims and deadline
- Runs the pre-check before formal review
- Applies the agreed edits in one consolidated pass
- Tracks campaign timelines against the review SLA
Medical
Owns clinical accuracy and fair balance
- Validates efficacy and safety language against the clinical evaluation report
- Checks for fair balance between benefits and risks
- Confirms statistical claims, citations and patient population framing
- Flags extrapolation beyond the studied indication
Regulatory
Owns compliance with the cleared or CE-marked scope
- Confirms every claim sits inside the intended purpose and indications for use
- Enforces EU MDR Article 7, FDA promotional rules and national advertising codes
- Checks regulatory marks, warnings, contraindications and disclaimers
- Acts as the reconciliation chair and final sign-off
Legal
Owns substantiation, IP and contractual risk
- Verifies the substantiation file behind every factual or comparative claim
- Checks trademarks, copyright and third party licences
- Confirms privacy, consent and data protection on patient stories or imagery
- Reviews partner, distributor and clinical site obligations
The five patterns that quietly add weeks
If you recognise more than one, fixing the workflow will return more time than any tool.
No named chair
When no one owns reconciliation, conflicting comments bounce back to Marketing and the asset cycles. Name a chair, usually Regulatory, and give them authority to decide.
Evidence requested mid-review
If evidence first appears in round three, every prior comment may need to be revisited. Lock the evidence pack at brief stage and treat new evidence as a new cycle.
Verbal decisions and no log
Decisions made in a meeting without a written rationale get relitigated on the next asset. Keep a short decisions log against the campaign or brand.
Marketing owner skips the pre-check
Asking Regulatory to find the off-label language is the most expensive way to find it. A 20 minute pre-check on the Marketing side typically removes a full review round.
Metrics to keep the process honest
Track these five and the workflow stops drifting back to its old shape.
Review rounds per asset
Total number of review-and-revise loops between first submission and final approval. Target: two or fewer for routine assets.
First-pass approval rate
Share of assets approved without substantive change after round one. Target: rising trend quarter on quarter.
Cycle time
Working days from submission to approval. Track by asset class so a complex campaign does not skew the average.
Reasons for revision
Categorised log of why edits were requested. Use the top categories to prioritise template fixes, training and tooling.
Post-launch issues
Complaints, regulator queries or PMS-triggered claim retractions tied back to approved assets. The leading indicator that the process is too loose.
Putting it together
An efficient MLR review process is not faster because people work harder. It is faster because the brief lands clean, the pre-check catches the obvious issues, the three functions review in parallel and a named chair makes the call.
For most medical device teams, the highest-leverage change is stage two. A structured pre-check on the Marketing side, against the same rules Regulatory, Medical and Legal apply, removes the easy comments before formal review starts. That is the single biggest lever for first-pass approval.
Pair this guide with the pre-submission checklist and the terminology guide so every reviewer is looking at the same brief, the same evidence pack and the same vocabulary.
The process described here is generic by design. Adapt the named chair, the review SLAs and the metrics to the size of your portfolio, the markets you cover and the regulatory pathway each device sits in.
Automate the pre-check stage
MLR PreCheck flags claim risks Marketing, Regulatory, Medical and Legal would catch, before the asset enters formal review. Built for medical device Marketing and Marcomms teams.