A practical pre-submission checklist for medical device Marketing and Marcomms teams. Use it to catch the issues that Regulatory, Medical and Legal will flag, before the asset enters formal MLR review.
The MLR review process is where most medical device marketing assets lose time. Eight rounds of comments, conflicting Regulatory and Legal feedback and last minute evidence requests are common, and almost all of it is avoidable. A short pre-submission pass by the Marketing owner closes the gap between draft and approval.
This checklist is built specifically for medical device MLR teams working under EU MDR, IVDR and FDA rules. It will not help you with prescription drug promotion or ABPI Code matters - those belong to a pharma checklist. Use the eight items below before you hit submit.
Eight checks to run on every asset before it enters MLR review.
List every standalone claim in the asset: performance numbers, comparative statements, safety language, indication wording and lifestyle implications. One claim per row, with the exact wording used.
For every claim, link to the source: clinical evaluation report, bench testing data, published study, technical file section or post-market surveillance summary. If a claim has no source, cut it or rewrite it before submission.
Every claim must sit inside the device's CE-marked intended purpose or FDA-cleared indications for use. Off-label or expanded-use language is the fastest way to a Regulatory rejection.
Marketing copy must not contradict the instructions for use, warnings, contraindications or precautions. Pull the latest approved IFU and cross-check terminology, populations and use environments.
Best-in-class, market-leading and head-to-head claims need head-to-head evidence. If you only have single-arm data, soften the wording or remove the comparison.
Note whether the asset is for healthcare professionals, patients or the general public. Some claims that are acceptable to clinicians are not acceptable to patients under national advertising codes.
Check device names, trademarks, regulatory marks (CE, UKCA, FDA cleared), partner logos and required disclaimers are present, correctly formatted and current.
Include the asset purpose, target audience, channel, deadline and a short summary of the evidence pack. A clear brief cuts clarifying questions and trims a round of review.
Anticipating each function's lens turns a slow back and forth into a single, clean review round.
The regulatory anchors that drive most MLR decisions for devices.
Article 7 of the EU Medical Device Regulation prohibits text, names, trademarks, pictures or signs that mislead the user about the device's intended purpose, safety or performance. That includes attributing functions or properties the device does not have, creating a false impression of safety, or failing to inform about likely risks. Treat Article 7 as the baseline filter for every promotional claim in the EU.
For US devices, every promotional claim must sit inside the indications authorised by the relevant pathway: 510(k) clearance, De Novo classification or PMA approval. Promoting a new indication, patient population, anatomical site or use environment that is not in the authorisation is treated as off-label promotion. If the marketing concept needs a wider claim, the path is a new or supplemental submission, not louder copy.
Claims about real world performance, durability or patient outcomes must trace back to the clinical evaluation or post-market surveillance system required under MDR Article 83 and IVDR Article 78. Do not cite preliminary PMS findings, internal complaints data or unverified registry signals as promotional evidence.
In vitro diagnostic and SaMD assets need extra care. Sensitivity, specificity and performance metrics must match the performance evaluation report. AI and algorithm claims need to reflect the validated use case, training data scope and any human-in-the-loop requirements stated in the technical documentation.
If any of these apply, rework before you submit.
For definitions of the terminology used above, see the MLR Terminology Guide.
MLR PreCheck flags the claim risks that Regulatory, Medical and Legal would catch - before the formal review begins. Built for medical device Marketing and Marcomms teams.
