What is not a medical device?
Regulatory basis - Exclusions from the MDR are set out primarily in Article 1(5) and 1(6) of Regulation (EU) 2017/745. Equivalent IVDR exclusions appear in Article 1(4) and 1(5) of Regulation (EU) 2017/746.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Borderline product decisions can be complex — always consult the official regulation and seek qualified advice when uncertain.
Overview
Not every product that touches healthcare is a medical device. Understanding what falls outside the MDR and IVDR is just as important as understanding what falls inside, because the regulatory burden is substantial and applying it unnecessarily wastes resources — while failing to apply it creates legal risk.
The two main routes for exclusion are:
- Explicit exclusions in the regulations themselves (Art. 1(5)–(6) MDR; Art. 1(4)–(5) IVDR)
- Definitional non-qualification — the product simply does not meet the conditions of the Article 2 definition
Explicitly excluded products
Medicinal products
Products that achieve their principal intended action by pharmacological, immunological, or metabolic means are medicinal products governed by Directive 2001/83/EC (or Regulation (EC) No 726/2004 for centrally authorised products), not medical devices.
This is the most significant borderline. A product may be:
- A medicinal product — if the drug/biological action is the principal mechanism
- A medical device — if a physical, mechanical, or other non-pharmacological mechanism is principal (even if a drug assists it)
- A drug-device combination — if integral, the primary mode of action determines which legislation governs (with specific involvement of both regulators)
Advanced therapy medicinal products (ATMPs)
Gene therapies, somatic cell therapies, and tissue-engineered products are governed by Regulation (EC) No 1394/2007 as ATMPs. However:
- A product combining an ATMP with a medical device component (e.g. a scaffold seeded with cells) is an ATMP combined product — governed by ATMP rules, but the device component must meet relevant MDR requirements.
Food products
Products regulated as food under Regulation (EC) No 178/2002 are excluded. Probiotic supplements, nutritional products, and dietary supplements with health claims fall under food law, not MDR, even if the manufacturer makes functional health claims — provided those claims are within what food law permits.
Cosmetics
Products within the scope of Regulation (EC) No 1223/2009 (cosmetics) are excluded from MDR. However, a product can cross into medical device territory if the manufacturer makes claims that imply a medical purpose. Examples:
| Product | Claim | Regulatory status |
|---|---|---|
| Sunscreen | "Protects against UV damage to skin" | Cosmetic |
| Sunscreen | "For use by patients post skin cancer surgery to prevent recurrence" | Likely medical device |
| Anti-wrinkle cream | "Reduces appearance of wrinkles" | Cosmetic |
| Dermal filler | Injected for augmentation | Medical device (Annex XVI MDR) |
Biocidal products
Disinfectants, sterilants, and antimicrobial products for environmental use fall under Regulation (EU) No 528/2012 (Biocidal Products Regulation). A product used to disinfect medical devices (e.g. an endoscope reprocessor) may itself be a medical device accessory — this is a complex borderline.
Blood, blood components, cells, tissues, and organs of human origin
These are excluded from MDR to the extent they are governed by other Union legislation (e.g. Directive 2002/98/EC on blood safety). However, a device that incorporates such material (e.g. a collagen matrix derived from human tissue) may still be a medical device — the human-derived material itself is regulated separately, but the finished device is assessed under MDR.
Products for veterinary use
Medical devices intended solely for veterinary use are outside MDR and IVDR scope. Veterinary medicinal products are governed by Regulation (EU) 2019/6.
A product that can be used on both humans and animals is not automatically excluded. If it is intended for human use — even alongside veterinary use — it falls within MDR/IVDR scope for that intended purpose.
Personal protective equipment (PPE)
PPE such as surgical masks worn to protect the wearer (not the patient) falls under Regulation (EU) 2016/425 (PPE Regulation). However:
- A surgical mask intended to prevent transmission from a surgical team member to a patient during surgery → may be a medical device (Class I, sterile or non-sterile depending on configuration)
- A respirator worn solely to protect the wearer → PPE
Products that do not meet the Article 2 definition
Beyond explicit exclusions, many products simply do not qualify because they lack the required elements:
General wellness products
Fitness trackers, sleep monitors, step counters, and similar products — when not marketed with medical claims — do not qualify as medical devices. The intended purpose must include a specific medical aim (diagnosis, treatment, monitoring of a disease or injury).
Products used solely for research
Products manufactured and used solely for research purposes, not placed on the market or put into service with an intended purpose for use on humans, fall outside the definition. However, once a device is used in a clinical investigation under MDR, the regulation applies.
Industrial and occupational products
Hearing protection for industrial noise environments (vs. hearing aids for hearing impairment), ergonomic office equipment, and similar products have no medical intended purpose.
Products in surgery where the mechanism is purely physical and non-medical
A suture used to close a wound is a medical device. A stapler used in an office is not — even if occasionally used to close skin in emergency situations by someone acting outside its intended purpose.
The borderline product problem
The MDR acknowledges that many products sit at the boundary between regulatory frameworks. The Medical Device Coordination Group (MDCG) maintains guidance specifically on borderline cases:
- MDCG 2022-5: Guidance on borderline between MDR and other legislation
- MDCG 2021-24: Software guidance (distinguishing SaMD from general-purpose software)
Additionally, the European Commission maintains a PRODCOM borderline database and publishes opinions through the MDCG Borderline and Classification Working Group.
A product is a medical device if the manufacturer claims it is for a medical purpose, regardless of how it is actually used. The safest approach for borderline products is to:
- Draft the intended purpose statement carefully
- Consult the MDCG borderline guidance
- Consider seeking a formal opinion from the relevant national competent authority
Quick reference: exclusion checklist
| Question | If YES → |
|---|---|
| Does the product act principally by pharmacological/immunological/metabolic means? | Likely a medicinal product (Directive 2001/83/EC) |
| Is it a gene therapy, cell therapy, or tissue-engineered product? | Likely an ATMP (Regulation 1394/2007) |
| Is it a food or dietary supplement with no medical claims? | Food law (Regulation 178/2002) |
| Is it a cosmetic with only cosmetic claims? | Cosmetics Regulation (1223/2009) |
| Is it a disinfectant for environmental surfaces? | Biocidal Products Regulation (528/2012) |
| Is it intended solely for veterinary use? | Veterinary legislation — outside MDR/IVDR |
| Does it have no specific medical intended purpose at all? | Not a medical device |
Related pages
- What is a medical device?
- What is an IVD?
- MDR vs IVDR — which applies?
- Devices incorporating a medicinal substance
Official references
| Reference | Description |
|---|---|
| MDR Art. 1(5)–(6) | Explicit exclusions from MDR scope |
| IVDR Art. 1(4)–(5) | Explicit exclusions from IVDR scope |
| MDR Art. 2(1) | Medical device definition (mode of action element) |
| MDCG 2022-5 | Guidance on borderline products |
| MDCG 2021-24 | Guidance on software qualification |
| Directive 2001/83/EC | Medicinal products for human use |
| Regulation (EC) No 1394/2007 | Advanced therapy medicinal products |