Updated July 2026. Scope: EU MDR 2017/745 and IVDR 2017/746, the legal manufacturer of a medical device and where accountability sits in OEM, private-label, and contract-manufacturing arrangements. For the definition on its own, see the legal manufacturer glossary entry.
Key takeaways
- The legal manufacturer is the entity that markets a device under its own name or trademark, even if another company physically makes it (MDR Article 2(30)).
- Putting your brand on someone else’s device makes you the legal manufacturer, with the full obligation set under MDR Article 10. Accountability does not stay with the factory.
- The reduced own-brand-labelling arrangement that notified bodies allowed under the old directives is gone. Under MDR, the brand owner is a full manufacturer.
- A distributor or importer can become the legal manufacturer by relabelling under its own name, changing the intended purpose, or modifying the device (MDR Article 16).
What “legal manufacturer” means for a medical device
MDR Article 2(30) defines a manufacturer as “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.”
Read the second half carefully. The definition explicitly includes the party that has a device made by someone else and markets it under its own name. Physical manufacturing is not the test. The name on the device is the test. If your brand is on it, you are the legal manufacturer, regardless of who ran the production line.
This is where OEM and private-label companies get caught out. The assumption that “we didn’t build it, so we are not the manufacturer” is exactly backwards under the regulation.
The obligations that come with the name
Being the legal manufacturer means carrying the general obligations in MDR Article 10. In outline:
| Obligation | What it means |
|---|---|
| Risk management | A documented, maintained risk management system across the device lifecycle |
| Clinical evaluation | Clinical evaluation and post-market clinical follow-up appropriate to the device |
| Technical documentation | Complete technical documentation per Annexes II and III, kept current |
| Conformity and marking | The EU declaration of conformity and CE marking after conformity assessment |
| Quality management system | A QMS proportionate to the risk class, covering design through post-market |
| Registration and UDI | Registering the device and the organisation and meeting UDI requirements |
| Record retention | Technical documentation retained for 10 years (15 for implantable devices) |
| Post-market surveillance and vigilance | PMS, corrective actions, and reporting under Articles 87 to 92 |
| PRRC | A person responsible for regulatory compliance under Article 15 |
None of these are optional for a private-label brand. If you are the legal manufacturer, they are yours.
OEM, private label, and own-brand labelling
Under the old Medical Device Directive, “own brand labellers” sometimes leaned on a lighter arrangement, relying heavily on the original maker’s documentation. MDR removed that shortcut. There is no reduced own-brand-labelling regime in the MDR. The entity marketing the device under its name is a full manufacturer with the full Article 10 obligation set.
In practice, this changes the contract between a brand and its original equipment manufacturer:
- The brand, as legal manufacturer, needs its own access to and control over the technical documentation, not just a promise that the OEM holds it.
- The brand needs its own QMS, its own PRRC, its own registration, and its own post-market surveillance.
- A supply agreement can define who does what operationally, but it cannot move the legal manufacturer’s regulatory accountability off the brand.
Treating an OEM relationship as if it outsources manufacturer status is the single most expensive misread in this area.
When a distributor or importer becomes the manufacturer
Accountability can also shift onto a distributor or importer. Under MDR Article 16, a distributor, importer, or other person takes on the obligations of a manufacturer if they:
- make a device available under their own name or trademark, unless there is an agreement where the actual manufacturer is still identified as the manufacturer on the label;
- change the intended purpose of a device already placed on the market; or
- modify a device already placed on the market in a way that can affect compliance.
Relabelling and repackaging within defined limits do not automatically trigger this, and Article 16 sets conditions for those activities. But a distributor that quietly rebrands or repurposes a device can inherit the whole manufacturer obligation set without intending to.
An accountability question, not a paperwork one
The through-line is accountability. The legal manufacturer is the party the regulation holds responsible for the device being safe, performing as intended, and staying compliant across its life. That responsibility attaches to the name on the device, and it does not transfer by contract to a factory, an OEM, or a supplier.
For a brand entering the EU market on someone else’s production, the right question is not “who makes it” but “whose name is on it, and does that entity actually hold the obligations that come with being the legal manufacturer.” When the answer is unclear, it is a gap to close before launch, not after an audit finds it.
Frequently asked questions
Who is the legal manufacturer under MDR?
The natural or legal person who markets a device under its own name or trademark, whether it manufactures the device itself or has it designed and manufactured by someone else (MDR Article 2(30)). The name on the device, not who physically makes it, decides who the legal manufacturer is.
If a contract manufacturer builds our device, are they the legal manufacturer?
Not if you market it under your name. The brand that markets the device under its own name or trademark is the legal manufacturer and carries the Article 10 obligations. The contract manufacturer’s role is defined by agreement, but that does not make it the legal manufacturer of your branded device.
Does own-brand labelling still get a lighter regulatory route?
No. The reduced own-brand-labelling arrangement from the old directives does not exist under MDR. The brand owner is a full manufacturer with the full obligation set.
Can a distributor become the manufacturer?
Yes. Under MDR Article 16, a distributor or importer takes on manufacturer obligations if it markets a device under its own name (outside a defined agreement), changes the device’s intended purpose, or modifies a device already on the market.
What obligations come with being the legal manufacturer?
The Article 10 set: risk management, clinical evaluation, technical documentation, conformity assessment and CE marking, a quality management system, registration and UDI, record retention, post-market surveillance and vigilance, and a person responsible for regulatory compliance under Article 15.
Related guides and services
- Regulatory Affairs support from CENIT Consulting: clarifying who the legal manufacturer is and closing the obligation gaps in OEM and private-label arrangements.
- Quality management support: the QMS, technical documentation control, and post-market processes a legal manufacturer has to own.
For the definition and its background, see the legal manufacturer glossary entry and the guide on legal manufacturer responsibilities.
This article is for general information only and is not legal or regulatory advice. Teams remain responsible for regulatory decisions and staying current with applicable regulations and guidance.
Talk to CENIT Consulting about legal-manufacturer accountability in your supply arrangement: book a 30-minute consult.