MDCG Q&A Document on Custom-Made Medical Devices

It is important to mention that the present document does not reflect the position of the European Commission and should be used for general consulting purposes. Due to its legal nature, it does not introduce the regulatory requirements the parties involved should follow. The MDCG also reserves the right to make amendments it deems necessary. 

The document also contains references to the guidance documents developed by the International Medical Device Regulatory Forum (IMDRF), a voluntary association of the national medical device regulating authorities collaborating for the further improvement of medical device regulations. In particular, the document refers to the IMDRF PMD WG/N49 FINAL: 2018, the guidance dedicated to the regulatory status of adaptable medical devices and patient-matched medical devices. 

Regulatory Background 

As it is stated by the MDCG, the present Q&A document is intended to address the main aspects related to custom-made medical devices subject to regulation under the Medical Devices Regulation 2017/745 (MDR), the new EU-wide regulation that replaces the Medical Devices Directive.

First, the present document provides the definition of a custom-made medical device set forth under the MDR. According to the aforementioned regulation, a custom-made medical device is the one that:

• Is specially made in accordance with a written prescription of any person authorized by the national law by virtue of that person’s professional qualifications; which gives
• Specific design characteristics provided under that person’s responsibility; and 
• Is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. 

The document also provides some examples of custom-made medical devices, such as dental crowns, orthosis, etc. 

At the same time, the document also outlines the medical devices that fall outside the scope of the custom-made device concept, namely: 

• Mass-produced medical devices requiring further adaptation,
• Mass-produced medical devices that could be made in accordance with the appropriate prescription provided that such devices are produced by means of the industrial manufacturing process. 

Another important concept used in the context of the present Q&A document is an adaptable medical device, which stands for the mass-produced medical devices which must be adapted, adjusted, assembled, or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer`s validated instructions to suit an individual patient`s specific anatomy-physiologic features prior to use. 

It is important to mention that under the applicable legislation, a healthcare professional or another person that conducts the actions necessary to adapt the adaptable medical device to meet the specific needs of a particular patient should not be treated as a medical device manufacturer, providing that such an adaptation does not result in a change to the intended purpose of a medical device initially indicated by its manufacturer. 

The document also describes the concept of a patient-matched medical device. According to the definition developed by the IMDRF, a patient-matched medical device is the one that: 

• Is matched to patient`s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and
• Is typically produced in a batch through a process that is capable of being validated and reproduced; and 
• Is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional. 

The MDCG emphasizes the following differences between custom-made and personalized medical devices: the latter are (i) produced in batches, and (b) do not require a written prescription. Thus, in the case of a patient-matched medical device, the medical device manufacturer remains the only party responsible for the safety and effectiveness of a medical device. 

For both adaptable and patient-matched medical devices described hereinabove the general regulatory requirements set forth under the MDR should be applied, including the procedures to be performed in order to place a new medical device on the EU market. These types of medical devices are not subject to regulations for custom-made medical devices. 

Components to the Custom-Made Medical Devices  

Besides the general regulatory requirements applicable for the medical devices themselves, the present document also highlights the most important points associated with the components within.

For instance, the IMDRF clarifies that in certain cases, the components to the custom-made, adaptable or patient-matched medical devices could be placed on the market as separate products. In such cases, they should have a CE marking and comply with the applicable regulatory requirements set forth under the general rules for medical devices depending on the intended purpose. 

The same approach should be applied for “intermediate products” – specific products intended to be used to manufacture custom-made medical devices. Such devices should be accompanied by detailed instructions describing the way the device should be prepared, configured, and applied. 

As mentioned before, the components to the custom-made, adaptable or patient-matched medical devices are subject to the same general regulatory requirements as any other medical device. Hence, they require a risk class determination in accordance with the risk-based classification. In this regard, the following aspects should be considered:

• The intended purpose of the final medical device;
• Whether the component in question is intended for manufacturing implantable medical device;
• The risks associated with the patient-contacting materials comprising the component in question. 

The MDCG additionally emphasizes that in case the properties of the product subject to review or the materials used therein could change during the manufacturing of a final medical device or its adaptation, the medical device manufacturer shall also demonstrate that the final medical device would comply with the applicable regulatory requirements set forth under the MDR. 

Another specific aspect relates to the risks for the persons engaged in the preparatory processing of custom-made, adaptable, or patient-matched medical devices. The medical device manufacturer shall demonstrate that such persons would not be exposed to unacceptable risks.  

Regulatory Requirements in Detail

The document also addresses numerous device-specific aspects to be considered by the medical device manufacturers interested in marketing their products in the EU.

According to the document, the medical device manufacturer is allowed to use any novel technologies it deems necessary in the course of the manufacturing process, including 3D printing. At the same time, the MDCG mentions that the use of a 3D printing technology itself does not result in a qualifying medical device in question as custom-made by default. In such case, the general criteria should be applied, namely:

• The device in question should be manufactured on the basis of a written prescription that contains patient-specific design characteristics;
• The device should be intended to be used only for the particular patient;
• The device should not be mass-produced. 

In summary, the present MDCG guidance covers the most important aspects related to custom-made, adaptable, and patient-matched medical devices. In particular, the document outlines the criteria to be applied to determine the type of medical devices and also describes the regulatory requirements such products should be subject to. 

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Sources:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-3_en.pdf