EU MDR FAQ Medical Purpose Claims

A product, including software, is within the MDR device definition when the manufacturer intends it to be used for one or more MDR medical purposes for human beings. Core medical-purpose language includes diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease, injury, or disability; investigation, replacement, or modification of anatomy or a physiological or pathological process or state; and certain in vitro information uses.

The MDR does not limit intended purpose to a single formal statement. It is read from data supplied by the manufacturer on the label, instructions for use, promotional or sales materials or statements, and as specified in the clinical evaluation. Advertising and product claims also matter because Article 7 prohibits claims that mislead users or patients about intended purpose, safety, or performance.

MDCG software guidance says software must have a medical purpose on its own to qualify as medical device software, unless it is an accessory, an Annex XVI product, or software that drives or influences a medical device. The location of the software, such as cloud, mobile, computer, or a hardware device, does not determine qualification.

The practical split is the function and intended purpose. General administration, invoicing, staff planning, storage, archival, communication, simple search, or population-only analytics are not enough by themselves. Software that processes, analyses, creates, or modifies medical information for an individual patient and for a medical intended purpose can qualify as medical device software.

Annex XVI is the MDR route for listed groups of products without an intended medical purpose, such as certain contact lenses, invasive anatomy-modification products, dermal fillers, adipose-tissue reduction equipment, high-intensity electromagnetic radiation equipment for skin treatment, and brain-stimulation equipment. That is different from saying a product has no MDR relevance.

The contrast matters: a product with both medical and non-medical intended purposes must satisfy both sets of applicable requirements. Do not use Annex XVI language to neutralize medical claims if the same product materials also claim diagnosis, treatment, monitoring, or another MDR medical purpose.

Keep the qualification record with the technical documentation or equivalent product-compliance file. MDR Annex II expects a product description including intended purpose and users, medical conditions to be diagnosed, treated or monitored where relevant, qualification rationale, classification rationale, labels, instructions for use, and user-facing specifications such as brochures or catalogues.

The evidence should let a reviewer reconstruct the decision without interviews. Keep the source rule, the claim inventory, the software or product function map, the intended-user and patient-population analysis, screenshots or controlled copies of claims, clinical-evaluation linkage where applicable, approvals, unresolved assumptions, and triggers for review after claim, feature, indication, user, output, or market changes.