Equivalent Spare Parts not from the Manufacturer: Article 23

Article 23 of Regulation (EU) 2017/745 governs the replacement of parts and components of medical devices already placed on the market, through the use of items manufactured and made available by third parties other than the manufacturer.

Article 23 – Parts and components

1. Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance, safety characteristics or intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.
2. An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended use of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.

The application of Article 23 is fundamental to ensure the safety and performance of medical devices even after the replacement of parts, even if these are not “original”. A correct interpretation and application of this article is therefore crucial for all actors involved in the life cycle of medical devices.

Equivalent Spare Parts (Article 23, Paragraph 1)

Interpretative Insights

In order to strengthen the following discussion, it is necessary that the insights reported below become a fundamental part of the interpretative framework of Article 23. Quoting:

• “Identical or similar”: the regulation does not provide a clear definition of what is meant by identical or similar. In general terms, an identical or similar item can be considered a component capable of performing the same function with technical characteristics comparable to those of the original component. This must occur without affecting the performance or compromising the safety of the device on which the spare part is installed. Consequently, it is essential that the spare part manufacturer is able to demonstrate that the latter fully preserves the safety standards of the original device, providing clear technical specifications and preparing supporting evidence kept available to the competent authorities of the Member States to prove equivalence with the original component.
• “Maintain or restore the function”: this implies that the replacement must be aimed at returning the device to its original operating conditions. It is therefore not an upgrade or modification that extends its functionality.

Equivalent Spare Part

Analyzing the subject of the first paragraph, it is possible to relate the concept of item to the more common and easily understandable concept of equivalent spare part.

The concept of equivalent spare part is not explicitly defined in the regulation, but it is reasonably deducible from the wording of Article 23, paragraph 1. This concept paves the way for the use of spare parts that are not necessarily produced by the same manufacturer of the original device, but that meet the same functional specifications, intended use, and safety requirements.

A spare part can be considered equivalent if it meets the following criteria:

• Functionality: it performs the same function as the original part, with at least equivalent performance.
• Interface: it physically fits and correctly integrates with the device, without requiring modifications.
• Materials and technical properties: it is made with materials that ensure the maintenance of the relevant safety and performance properties of the device (e.g., biocompatibility, resistance, durability, etc.)
• Compliance: it meets the same safety and performance standards applicable to the original part.

Responsibility and Approach

Anyone who makes an equivalent spare part available on the market has the responsibility to ensure that the replacement does not compromise or alter the safety and performance of the device. This implies the need to implement and document processes that demonstrate the compliance of spare parts with the safety and performance standards of the original device and how it is not altered by the use of the equivalent component.

Fulfilling the above-mentioned requirements therefore requires an assessment action that can be broken down into:

• Verify and demonstrate that the part is physically and functionally compatible with the device and comparable to the original spare part.
• Perform appropriate tests to demonstrate that the replacement does not negatively affect the safety and performance of the original device.
• Document that all possible assessment actions have been undertaken and implemented with the aim of demonstrating and documenting the continued performance and safety requirements of the original device.

Although the responsibility lies with the person making the spare part available, the manufacturer of the original device also has a fundamental role in providing clear information about the nature and adequacy of spare parts, for example, through the device’s user manual.
Consequently, it is good practice for the manufacturer of the equivalent spare part to communicate with the manufacturer of the original device to obtain technical information to improve and ensure the compatibility of the spare part itself.

Practical Examples, What Can be Considered as an Equivalent Spare Part?

• Batteries: a battery from another brand, but with the same voltage, capacity, size specifications, etc. can be considered an equivalent spare part for a medical electronic device.
• Cases: ECG cases produced by a company different from that of the medical device, but with the same characteristics of size, color, material, biocompatibility, etc. can be considered an equivalent spare part.
• Tubing: infusion tubes with the same dimensions, materials, and sterility characteristics can be considered equivalent spare parts.

Items that Substantially Modify the Original Device (Article 23, Paragraph 2)

Interpretative Insights

In order to strengthen the following discussion, it is necessary that the insights reported below become a fundamental part of the interpretative framework of the second paragraph. Quoting:

• “Substantially modifies”: the regulation does not provide a precise definition. However, it can be interpreted as any modification that has an impact on one or more of the following aspects:
  • Operating principle: for example, replacing a sensor with one that uses a different measurement technology.
  • Materials: the use of different materials that could affect the biocompatibility, resistance, or durability of the device.
  • Software: modifications to the software that controls the operation of the device.
  • Intended use: the extension of the therapeutic or diagnostic indications of the device.
• “Is considered to be a device and shall meet the requirements laid down in this Regulation”: the substantial modification necessitates a new conformity assessment process and a new CE marking for the modified device.

Responsibility

Paragraph 2 deals with those items that substantially modify the safety characteristics, performance, or intended use of the device on which they are implemented. In this case, the item is no longer considered a simple spare part, but is classified as a new medical device in all respects that must meet all the requirements set out in Regulation (EU) 2017/745.
Therefore, those who make such items available, making substantial modifications to the original device, have the responsibility to follow the entire conformity assessment process required by the MDR.

Paragraph 2 of Article 23 is therefore fundamental to avoid unauthorized modifications to medical devices that could change – even if with a view to improvement – their safety and effectiveness.

Conclusions

From what has been discussed, and particularly for aspects related to equivalent spare parts, it is possible to conclude that:

• The use of equivalent spare parts can be considered an acceptable and advantageous practice;
• In the case of an equivalent spare part, the need to formalize and support the absence of impact on the medical device must push the manufacturer to pay great attention in evaluating the conformity and sustainability of the supporting documentation;
• The lack of a formal definition of “identical or similar” makes a preliminary and formal sharing with the manufacturer of the medical device for which the spare part is intended fundamental.