Resources

MLR Terminology Guide

A practical glossary of Medical, Legal and Regulatory terms for medical device teams. Understand the review process, key acronyms and compliance language that shapes every piece of marketing copy.

Built for medical devices, not pharma

What does MLR mean?

MLR stands for Medical, Legal and Regulatory review. It is the mandatory compliance process through which marketing materials are checked by Medical, Legal and Regulatory professionals before they can be published or distributed. The goal is to ensure that every claim is accurate, fair, balanced and supported by evidence.

In the medical device industry, the MLR review process focuses on conformity with regulations such as the EU MDR and IVDR, FDA rules, and national advertising codes. Unlike pharmaceutical MLR, which often involves prescription drug promotion rules like FDA OPDP or the ABPI Code, medical device MLR is centred on technical documentation, intended purpose and clinical evidence.

A typical MLR review process involves multiple rounds of comment, revision and re-check. Marketing and Marcomms teams draft the copy, then submit it to Regulatory, Medical and Legal reviewers who flag non-compliant claims, request evidence and suggest rewording. The asset cycles back and forth until all teams sign off.

Glossary of MLR terms

Definitions and medical device context for the terminology you will encounter in MLR review.

Medical, Legal and Regulatory Review

MLR

The formal review process in which Medical, Legal and Regulatory teams evaluate marketing materials to ensure compliance with applicable laws, regulations and company policies before publication or distribution.

Why it matters in review

Every piece of marketing copy - brochures, websites, conference slides, emails - must pass MLR review before it can be used externally.

Medical device nuance

For medical devices, MLR focuses on conformity with the EU MDR/IVDR, FDA labelling rules under 21 CFR Part 801 and the misbranding provisions of section 502 of the FD&C Act, plus applicable guidance documents. Unlike pharma, device reviews rarely involve prescription drug promotion rules such as FDA OPDP or the ABPI Code.

MLR Review Process

The structured workflow through which a marketing asset moves from draft creation to final approval. Typically involves submission, parallel or sequential review by Medical, Legal and Regulatory, comment resolution, and final sign-off.

Why it matters in review

A well-run MLR review process prevents non-compliant claims from reaching healthcare professionals and patients.

Medical device nuance

Medical device teams often face shorter approval timelines than pharma. A streamlined MLR process that flags claim risks early - before formal review - can cut approval rounds from eight to two.

Promotional Review Committee

PRC

A cross-functional committee responsible for reviewing and approving promotional materials. In many organisations the PRC is synonymous with the MLR review body, though some companies maintain separate PRC and MLR workflows.

Why it matters in review

The PRC ensures that all claims are accurate, balanced, fair and supported by evidence before materials are released.

Medical device nuance

For medical devices, the PRC typically includes Regulatory Affairs, Quality Assurance and Clinical Affairs representatives who assess technical documentation and clinical evidence alongside the marketing message.

Substantiation

The requirement that every claim made in marketing materials must be supported by adequate evidence. Substantiation can come from clinical studies, bench testing, post-market surveillance data, or published literature.

Why it matters in review

Unsubstantiated claims - such as 'best-in-class' or 'most advanced' without head-to-head data - are among the most common reasons materials are rejected during MLR review.

Medical device nuance

Under EU MDR Article 7 and FDA guidance, medical device claims must be supported by data held in the technical documentation or clinical evaluation report. Marketing cannot make claims beyond what is cleared or CE-marked.

Off-label use

The use of a medical product for an indication, patient population, dosage or route of administration that is not included in the approved or cleared labelling.

Why it matters in review

Promoting off-label use is prohibited in most jurisdictions. Even implied references to unapproved uses can trigger regulatory enforcement.

Medical device nuance

For devices, off-label use includes indications not covered by the CE certificate or by FDA 510(k) clearance, De Novo classification or PMA approval. Marketing materials must stay within the intended purpose stated in the Declaration of Conformity or the US submission.

Medical Device Regulation

MDR

EU Regulation 2017/745, which governs the placing on the market and post-market surveillance of medical devices in the European Union. It became applicable on 26 May 2021, replacing the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

Why it matters in review

The MDR introduced stricter clinical evidence requirements, strengthened post-market surveillance obligations, and created the EUDAMED database for device traceability.

Medical device nuance

Marketing materials for EU-bound devices must align with the MDR's requirements on claims, including Article 7 (claims must be supported by data) and the obligations on vigilance and post-market clinical follow-up.

In Vitro Diagnostic Regulation

IVDR

EU Regulation 2017/746, which governs in vitro diagnostic medical devices in the European Union. It replaced the In Vitro Diagnostic Directive (IVDD) and introduced a risk-based classification system with stricter conformity assessment for higher-risk devices.

Why it matters in review

IVDR marketing claims must be consistent with the device's intended purpose, performance characteristics and clinical evidence.

Medical device nuance

IVD marketing is especially sensitive to claims about diagnostic accuracy, sensitivity and specificity. Any claim about clinical performance must be traceable to the clinical evidence in the technical documentation.

Intended purpose

The use for which a device is intended according to the manufacturer's specifications, as stated in the instructions for use, labelling and promotional materials. The intended purpose defines the boundaries of what can legally be claimed.

Why it matters in review

Marketing copy that drifts beyond the intended purpose - even subtly - risks being classified as off-label promotion or misbranding.

Medical device nuance

Under MDR Article 2(12) (definition of intended purpose) and FDA regulations, the intended purpose must be consistent across the technical file, labelling and all promotional materials. MLR review ensures marketing does not inadvertently expand the intended use.

Indication for use

A description of the medical conditions, patient populations and clinical settings in which a device may be used, as cleared or approved by the relevant regulatory authority.

Why it matters in review

The indication for use forms the legal boundary of promotional claims. Any marketing statement that suggests broader or different use is non-compliant.

Medical device nuance

For devices, the indication is typically narrower than for drugs and tied closely to the clinical evaluation. Marketing teams must ensure that patient population descriptors and clinical setting references stay within the cleared indication.

Absolute claim

A claim that uses unqualified superlatives or definitive language - such as 'eliminates', 'guaranteed', 'risk-free' or '100% effective' - that overstates safety or efficacy.

Why it matters in review

Absolute claims are among the highest-risk wording patterns in MLR review. They are almost always rejected because no medical device can legitimately claim zero risk or universal efficacy.

Medical device nuance

FDA guidance and EU MDR both require that claims be balanced and not overstate benefit. Absolute safety claims are particularly scrutinised because they may discourage proper use or mask residual risks.

Comparative claim

A claim that positions a product as superior, equivalent or different to another product, treatment or standard of care. Comparative claims require robust head-to-head evidence.

Why it matters in review

Marketing teams often want to claim superiority over competitors, but MLR review will reject any comparative claim that lacks directly comparative clinical or performance data.

Medical device nuance

For devices, comparative claims must be supported by bench testing or clinical data that directly compares the devices under the same conditions. Indirect comparisons or market-share data are generally insufficient.

Vague endorsement

A statement that implies broad acceptance, recommendation or preference without specific, verifiable evidence - such as 'trusted by hospitals worldwide' or 'preferred by clinicians'.

Why it matters in review

Vague endorsements fail substantiation because they cannot be traced to specific data. MLR review requires either removal or replacement with a qualified, evidence-backed statement.

Medical device nuance

In the medical device sector, vague endorsements can also mislead about the level of clinical acceptance. MDR and FDA require that claims reflect the actual state of clinical evidence, not generalised popularity.

Conformity assessment

The process by which a manufacturer demonstrates that a medical device meets the essential requirements of the applicable regulation (MDR, IVDR or FDA rules) before placing it on the market.

Why it matters in review

The outcome of conformity assessment is a CE mark (EU) or FDA clearance/approval (US). Marketing materials must not suggest capabilities beyond what was assessed.

Medical device nuance

Marketing teams sometimes conflate conformity assessment with clinical validation. MLR review ensures that promotional claims are scoped to the actual conformity assessment outcome, not broader capabilities.

Post-market surveillance

PMS

The systematic process of collecting, analysing and acting on data about a device's performance and safety after it has been placed on the market. PMS obligations are mandated under MDR, IVDR and FDA regulations.

Why it matters in review

PMS data can inform updates to instructions for use and risk management files, but marketing should not cite preliminary or unverified PMS findings as evidence for promotional claims.

Medical device nuance

Under MDR Article 83 and IVDR Article 78, manufacturers must maintain a post-market surveillance system. Marketing should be careful not to reference ongoing surveillance data as confirmed clinical evidence.

Clinical evaluation

A systematic and planned process used to demonstrate that a medical device is safe and performs as intended, based on clinical data. The clinical evaluation report (CER) is a key component of the technical documentation.

Why it matters in review

Claims about clinical performance, patient outcomes or safety profiles must be traceable to the clinical evaluation or equivalent evidence base.

Medical device nuance

MDR Article 61 and Annex XIV set out the requirements for clinical evaluation. Marketing claims that go beyond the scope or conclusions of the CER are non-compliant and will be rejected in MLR review.

Put this knowledge into practice

MLR PreCheck helps Marketing and Marcomms teams flag the claim risks that Regulatory, Medical and Legal would catch - before the formal review begins.

Start free trial See how it works