Manufacturer

In the EU, what counts is placing the device on the market under one's own name or trademark, so a company that outsources all design and production is still the manufacturer with every obligation that goes with it. US rules cast a wider net in some parts, covering repackagers, relabelers and specification developers.

‘manufacturer’ means 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;

EU MDR, Article 2(30)

‘manufacturer’ means 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 trade mark;

IVDR, Article 2(23)

Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes, but is not limited to, those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions. Organization shall have the meaning of “manufacturer” as defined in this part.

21 CFR, 820.3

Manufacturer means any person, including any importer, repacker, and/or relabeler, who manufactures, prepares, propagates, compounds, assembles, processes a device, or engages in any of the activities described in § 807.3(d) of this chapter.

21 CFR, 822.3

Manufacturer means any person, including any importer, repacker and/or relabeler, who manufactures, prepares, propagates, compounds, assembles, or processes a device or engages in any of the activities described in § 807.3(d) of this chapter.

21 CFR, 821.3

Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedures. The term includes any person who: (1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user or consumer; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; or (3) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and are intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient.

21 CFR, 806.2

Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either: (1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture; (2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications; (3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or (4) Is the U.S. agent of a foreign manufacturer. (m) Manufacturer or importer report number. This number uniquely identifies each individual adverse event report submitted by a manufacturer or importer. This number consists of the following three parts: (1) The FDA registration number for the manufacturing site of the reported device, or the registration number for the importer. If the manufacturing site or the importer does not have an establishment registration number, we will assign a temporary MDR reporting number until the site is registered in accordance with part 807 of this chapter. We will inform the manufacturer or importer of the temporary MDR reporting number; (2) The four-digit calendar year in which the report is submitted; and (3) The five-digit sequence number of the reports submitted during the year, starting with 00001. (For example, the complete number will appear as follows: 1234567-2011-00001.)

21 CFR, 803.3

natural or legal person with responsibility for the design or manufacture, or both, of a medical device with the intention of making the medical device available for use, under his or her name; whether or not such a medical device is designed or manufactured, or both, by that person themselves or on their behalf by another person(s) Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3 to entry: “Design or manufacture, or both”, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. Note 6 to entry: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design, manufacture, or both, of that accessory is considered to be a manufacturer. [SOURCE: ISO 14971:2019,[8] 3.9]

ISO 15223-1:2021, clause 3.10

natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) Note 1 to entry: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3 to entry: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. Note 6 to entry: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer. [SOURCE: GHTF/SG1/N055:2009, 5.1]

ISO 13485:2016, clause 3.10

natural or legal person with responsibility for the design and/or manufacture of a medical device (3.10) with the intention of making the medical device (3.10) available for use, under his name, whether or not such a medical device (3.10) is designed and/or manufactured by that person himself or on his behalf by another person(s) Note 1 to entry: The natural or legal person has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3 to entry: “Design and/or manufacture” may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. Note 6 to entry: An authorised representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer. [SOURCE: ISO/IEC Guide 63:2019, 3.6]

ISO 14971:2019, clause 3.9

natural or legal person with responsibility for the design, development, packaging, or labelling of a HEALTH SOFTWARE PRODUCT, or adapting a HEALTH SOFTWARE PRODUCT before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party Note 1 to entry: For a definition of labelling, see ISO 13485:2016, 3.8. Note 2 to entry: Developer” or “developer organization” are commonly used terms instead of MANUFACTURER in the context of health information technology.

IEC 82304-1:2016, clause 3.10

natural or legal person with responsibility for designing, manufacturing, packaging, or labelling a MEDICAL DEVICE; assembling a SYSTEM; or adapting a MEDICAL DEVICE before it is placed on the market and/or put into service, regardless of whether these operations are carried out by that person or by a third party on that person’s behalf NOTE 1 Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer. NOTE 2 For a definition of labelling, see ISO 13485:2003, definition 3.6. [ISO 14971:2007, 2,8]

IEC 62304:2006+AMD1:2015, clause 3.10

For the purposes of this document, the term manufacturer includes any 510(k) holder, even if that person does not actually fabricate the existing device. The term also includes a person who manufactures a preamendments device of a type subject to premarket notification (510(k)), and a person who manufactures a device that was granted marketing authorization via the De Novo classification process.

FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device (October 2017), Appendix C, Significant Terminology

The EU MDR and IVDR tie the role to marketing the device under one's own name or trademark. The 21 CFR definitions list activities instead: 820.3 covers anyone who designs, manufactures, fabricates, assembles or processes a finished device, including contract sterilizers, relabelers and specification developers, while 821.3 and 822.3 expressly include importers. The FDA 510(k) change guidance adds that any 510(k) holder counts, even one that does not make the device.