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Regulatory Update - Medical Devices, Components and Accessories

Friday, December 2, 2022
Q4 Regulatory Update. Medical Devices Components and Accessories

Regulatory, compliance and quality management system considerations may vary between medical devices, components and accessories. Understanding these differences helps organizations to better identify their roles and responsibilities related to sales, labeling and marketing authorization for these different categories.

FDA regulatory basis

The FDA, specifically the Center for Devices & Radiological Health (CDRH), regulates medical devices in the United States according to:

  • The Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • The Medical Device Amendments of 1976
  • U.S. Code of Federal Regulation Title 21 Parts 801, 803, 807, 812, 814, 820, and related parts

“Medical device” is defined in Section 201(h) of the FD&C Act as follows and specifically includes components and accessories by way of the underlined text:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

However, 21 CFR 820 states, “This regulation does not apply to manufacturers of components or parts of finished devices.” Therefore, compliance to 21 CFR 820 is ultimately a responsibility for finished device manufacturers and managed via internal and supplier controls.

EU regulatory basis

Regulation (EU) 2017/745 (“the EU MDR”) defines medical device as follows and includes components and accessories by way of various sections of the regulation and the underlined text:

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  2. diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  3. investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

FDA and EU regulatory requirement differ among categories

Given that component and accessories are included in this definition, how do FDA and EU requirements apply differently to these categories? First, and as noted above, medical devices, components and accessories offered for use in the above-described applications must conform to applicable regulatory requirements. The organization offering these products for the above-described purposes (e.g., diagnosis or treatment of a disease) is ultimately responsible for compliance to regulatory requirements.

However, the pre-market aspects (e.g., 510(k) clearance, CE-marking) vary depending on:

  • the classification of the item (if the item is a medical device or accessory)
  • the marketing authorization for the medical device being offered to end users or the medical device for which the accessory or component is offered to end users
  • how the item is offered to end users

Note that we are describing the item being “offered to end users” and not “offered for sale.” This is an important distinction – regardless of whether the device is sold or given to an end user, the requirements are the same.

In general, accessories are treated like distinct medical devices, whereas components are treated like part of the parent device.

Pre-market process

As you are likely aware, there is a host of marketing authorization processes in the US and EU for medical devices, and each is based on the classification, or lack thereof, of the device. Most devices require some type of marketing authorization from the regulatory authorities before you make them available to users. If you’d like to learn more about this topic, resources provided by the FDA1 or the applicable EU regulation2 and guidance3 are the best place to start.

Generally speaking, accessories may be cleared or approved by the FDA based on the classification and product code for the parent device – the device with which the accessory is intended for use. The applicant may include the accessory in the marketing application or submit an application specifically for the accessory. A different approach would be to file an application under a product code and classification issued specifically for the accessory. The approach taken will depend on the availability of applicable product codes and the regulatory strategy for the accessory and parent device.

Per US regulation and FDA policy, a component (any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device) is regulated as a medical device. However, a component is not a finished device and is not cleared or approved independently from the finished device. Therefore, while GMPs (Good Manufacturing Practices) apply to such components as they are incorporated into finished devices, pre-market and labeling requirements do not apply.

Similarly, EU regulation requires pre-market authorization for medical device accessories, and the regulation applies equally to medical devices and accessories as defined in the scope of the regulation. The regulation specifies that the term “devices” in the regulation applies to both medical devices and their accessories. Therefore, there is no practical difference between these two from a pre-market perspective. The technical documentation developed for a medical device or accessory (for CE-marking) must specify devices used in combination with one another. In other words, medical device documentation must identify any accessories used with the device and vice versa.

Article 23 of the EU MDR states that any item that replaces a part or component of a device AND that significantly changes the performance, safety characteristics or the intended purpose of the device shall be considered to be a device and meet the device regulations. Therefore, we can deduce that pre-market requirements for identical replacement components do not apply for components provided for replacement or servicing.

In summary, pre-market authorization and registration requirements do not apply to parts and components offered as part of a medical device or as like-for-like replacements.

UDI (Unique Device Identifier) labeling

In the United States and in the EU under the new Medical Device Regulations, Unique Device Identifiers (“UDIs”) are required on devices and/or labeling for medical devices and accessories. That is, medical devices or separately offered accessories each require their own UDI. A configurable device or system composed of various parts, components or modules may be assigned a single UDI. However, any accessories that are offered for use with a medical device must have its own UDI. Components or accessories of a medical device that are only packaged and sold with a medical device do not require a UDI, as the parent device is assigned a UDI and the component packaging is labeled with the same UDI.

If the replacement parts are regulated by the FDA as medical devices on their own and bear distinct device labels, they are required to bear a UDI for distribution in the US. Otherwise, a component (any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device) is not a finished device, is not cleared or approved independently from the finished device, and does not require a UDI4 In this case, a replacement component does not require a UDI in the US, even if sold separately.

However, UDI considerations for components in the EU regulation are worded in a more complicated manner. The EU MDR states the following about UDI assignment for components:

  • any item that is intended specifically to replace a part or component of a device and that significantly changes the performance, safety, or intended purpose of the device is considered a device and UDI requirements apply to the component
  • each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI
  • each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI

Therefore, components (e.g., replacement parts) that are commercially available on their own AND are considered a device require a UDI. We know from Article 23 that a component is considered a medical device if it significantly changes the performance, safety characteristics or the intended purpose of the device. In this case, an identical replacement component would not require a UDI in the EU, even if sold separately.

In summary, all medical devices and medical device accessories require UDIs. Components do not require their own UDI if they are not considered a medical device, are provided as part of a medical device, or are identical replacements for a part of component in a medical device.

References

  1. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device↩
  2. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745↩
  3. https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en↩
  4. Confirmed by the FDA UDI Help Desk on September 21, 2022.↩