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Manufacturers

Regulatory basis

MDR Article 10 and IVDR Article 10 set out the general obligations of manufacturers. Definitions appear in MDR Article 2(30) and IVDR Article 2(27).

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.

Who is a manufacturer?​

A manufacturer is any natural or legal person who:

  • Manufactures or fully refurbishes a medical device, or
  • Has a device designed, manufactured, or fully refurbished by another party, and
  • Places that device on the market under their own name or trademark, or puts it into service for their own purposes.

This definition captures several business models:

Business modelManufacturer status
Original equipment manufacturer (OEM) who designs and builds the device✅ Manufacturer
Brand-owner who contracts a CMO to build and sells under own label✅ Manufacturer
Contract manufacturer building under another company's label❌ Not the manufacturer (the brand-owner is)
Healthcare institution that builds an in-house device for own use✅ Manufacturer (limited exemption may apply — MDR Art. 5(5))
Distributor who repackages or relabels a device✅ Becomes a manufacturer
Company that fully refurbishes a single-use device✅ Becomes a manufacturer

Where must the manufacturer be established?​

Manufacturers may be established inside or outside the EU:

  • EU-established manufacturers deal directly with notified bodies, competent authorities, and the supply chain
  • Non-EU manufacturers must designate an EU Authorised Representative (EU REP) before placing a device on the EU market — there are no exceptions

Core obligations under MDR/IVDR Article 10​

Article 10 of both regulations sets out an extensive list of manufacturer obligations. These are organised below by lifecycle phase:

Design and development​

  • Establish, document, implement, and maintain a Quality Management System (QMS) covering all stages of the device lifecycle, proportionate to the risk class (Art. 10(9))
  • Perform a conformity assessment using the applicable procedure (MDR Annex IX, X, or XI; IVDR Annex IX, X, or XI)
  • Prepare and maintain technical documentation (MDR Annex II and III; IVDR Annex II and III)
  • Establish and maintain a risk management system throughout the entire lifecycle (in accordance with a risk management process, including ISO 14971)
  • Conduct clinical evaluation (MDR) or performance evaluation (IVDR) as part of the technical documentation
  • Apply the general safety and performance requirements (GSPR) in MDR/IVDR Annex I to the design and manufacture of the device

Conformity and CE marking​

  • Undertake the applicable conformity assessment procedure before placing the device on the market
  • Draw up an EU declaration of conformity (DoC) (MDR Annex IV / IVDR Annex IV)
  • Affix the CE marking in accordance with MDR Article 20 / IVDR Article 18
  • Register the device and relevant data in EUDAMED (Art. 29–30 MDR)
  • Apply a Unique Device Identifier (UDI) to the device and its packaging (MDR Art. 27 / IVDR Art. 24)

Labelling​

  • Ensure the device bears labelling that meets MDR Annex I §23 / IVDR Annex I §20 requirements
  • Provide instructions for use (IFU) in the official language(s) of the Member State(s) where the device is made available (unless eIFU rules apply)

Post-market​

  • Establish a post-market surveillance (PMS) system proportionate to the risk class (MDR Art. 83–86 / IVDR Art. 78–82)
  • Prepare a PMS plan and maintain PMS reports or a Periodic Safety Update Report (PSUR) as required by device class
  • Conduct post-market clinical follow-up (PMCF) for MDR devices / post-market performance follow-up (PMPF) for IVDR devices
  • Report serious incidents and carry out field safety corrective actions (FSCA) as required by the vigilance system (MDR Art. 87–92 / IVDR Art. 82–87)
  • Maintain distribution records sufficient to enable field safety actions to reach users

Organisational​

  • Designate at least one Person Responsible for Regulatory Compliance (PRRC) (MDR Art. 15)
  • Cooperate with competent authorities and provide information on request
  • Inform the EU REP (if applicable), notified body, and relevant competent authorities of corrective actions
  • Keep all records for a minimum of 10 years after the last device was placed on the market (15 years for implantables)

Quality Management System requirements​

The QMS must cover at minimum (MDR Art. 10(9)):

  1. A strategy for regulatory compliance
  2. Identification of applicable general safety and performance requirements
  3. Responsibility of management
  4. Resource management (including supplier and subcontractor management)
  5. Risk management
  6. Clinical evaluation / performance evaluation and PMCF / PMPF
  7. Product realisation (design, manufacture, etc.)
  8. UDI assignment
  9. Setting up, implementation, and maintenance of the PMS system
  10. Communication with competent authorities, notified bodies, and economic operators
  11. Handling of corrective and preventive actions (CAPA) and non-conformities
  12. Monitoring and measurement of outputs, data analysis, and product improvement
tip

ISO 13485:2016 is the internationally recognised standard for medical device QMS. While not legally mandatory under MDR/IVDR, compliance with ISO 13485 is generally taken by notified bodies as a primary means of demonstrating compliance with the QMS requirements of Art. 10(9).

The manufacturer bears ultimate legal responsibility for the safety and performance of the device. This cannot be fully transferred to:

  • A contract manufacturer
  • A distributor
  • An EU REP (though the EU REP shares legal responsibility with the manufacturer)
  • A notified body (NBs certify conformity but do not assume product liability)

Manufacturers who use contract manufacturers, OEMs, or other third parties remain responsible for ensuring those parties meet all applicable requirements. This must be documented in the QMS (Art. 10(1)).

Economic operator identification​

Manufacturers must ensure that their name, registered trade name or trademark, and the registered address at which they can be contacted appears on:

  • The device itself, or where not possible
  • The device's packaging or in a document accompanying the device

This information must be updated if the manufacturer's details change. Manufacturers must register their details in EUDAMED and receive a Single Registration Number (SRN) before placing devices on the EU market.

Official references​

ReferenceDescription
MDR Art. 2(30)Definition of manufacturer
MDR Art. 10General obligations of manufacturers
MDR Art. 15PRRC requirements
MDR Art. 20CE marking rules
MDR Art. 27UDI requirements
MDR Art. 29–30EUDAMED registration
IVDR Art. 2(27)Definition of manufacturer (IVDR)
IVDR Art. 10General obligations of manufacturers (IVDR)
MDCG 2019-6Guidance on the PRRC
ISO 13485:2016Medical device QMS standard