EU MDR Applicability Test

Capture the exact intended purpose from labels, instructions for use, website claims, clinical workflow descriptions, sales material, and the clinical evaluation. Under Article 2(1), a medical device includes software and other articles intended by the manufacturer for specified medical purposes such as diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation, investigation, replacement, modification, or providing information by in vitro examination of human specimens.

Also identify the regulated activity. Article 1 applies to placing a device on the Union market, making it available, putting it into service, and clinical investigations conducted in the Union. A product can meet the device definition while a particular prototype, export-only transaction, in-house use, or investigational use follows a different MDR route or exception.

Record whether the principal intended action is achieved by pharmacological, immunological, or metabolic means. If that action is principal rather than ancillary, the MDR record should flag a medicinal-product interface instead of forcing the product into MDR qualification.

If the product is not itself a medical device, test whether it is an accessory. Article 2(2) covers an article intended to be used with one or more particular medical devices to enable their intended purpose or directly assist their medical functionality.

For software, do not decide applicability from hosting location, app format, cloud deployment, healthcare use, or failure risk alone. MDCG 2019-11 Rev.1 says software must have a medical purpose on its own to qualify as medical device software. Software that drives or influences a hardware device without its own medical purpose may instead be a part, component, or accessory. Simple search, storage, communication, invoicing, staff planning, and similar non-medical functions do not qualify on that basis alone; a search or data function can qualify when it processes information to achieve a medical purpose.

A product can be in MDR scope even when the manufacturer claims only an aesthetic or another non-medical purpose. MDR Article 1(2) brings an Annex XVI group into the MDR from the date the relevant common specifications apply, and Article 1(3) requires products with both medical and non-medical intended purposes to meet both sets of applicable requirements.

Use the Annex XVI check for contact lenses, invasive body-modification products, dermal or mucous membrane fillers, equipment to reduce or remove adipose tissue, high-intensity optical radiation equipment for skin treatment, and non-invasive brain-stimulation equipment. Commission Implementing Regulation (EU) 2022/2346 lays down common specifications and risk-management records for those groups.

Record the exclusions and interfaces that support the final result. MDR Article 1 excludes IVDs covered by Regulation (EU) 2017/746, medicinal products where the medicinal action is principal, advanced therapy medicinal products, cosmetics, food, and certain human, animal, or viable biological materials, while also preserving MDR assessment for device parts in some combination products.

For combination or interface cases, describe the device part, the non-device part, the intended combined use, the principal mode of action, and whether the MDR still applies to the device component or accessory function. An integral product governed as a medicinal product can still have to meet the relevant Annex I requirements for its device part.

Article 5(5) creates a conditional in-house route. The device must be manufactured and used only within a Union health institution, it cannot be transferred to another legal entity, and the institution must manufacture it under an appropriate quality management system. The institution must also justify in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate performance level, by an equivalent device available on the market.

The institution must give its competent authority information on request, draw up documentation that identifies the manufacturing facility and explains the design, manufacturing process, intended purpose and performance, and make a public declaration containing the information required by Article 5(5)(e). It must ensure that manufacture follows the documented design and process, review experience from clinical use, and take necessary corrective action. The Article 5(5) exemption does not apply to devices manufactured on an industrial scale. National law can restrict the route further, and Member States may require additional information or inspections.

Once applicability is confirmed, classification is the next separate step. Article 51 divides devices into classes I, IIa, IIb, and III based on intended purpose and inherent risks, and classification is carried out under Annex VIII.

For software, MDCG 2019-11 Rev.1 points to Annex VIII rules including the rule that software driving or influencing a device falls within the same class as the device, independent software is classified in its own right, and where multiple rules apply the stricter rule leading to the higher classification applies. Rule 11 then addresses software used for diagnosis or therapeutic decisions and physiological monitoring.