This article allows to understand differences between custom-made medical devices (including class III custom-made implantable devices) belonging to group of “personalized medical devices” and other medical devices which also belong to “personalized medical devices” but are not considered as custom-made.
"Understanding the nuances of 'personalized medical devices' is crucial. Whether custom-made, adaptable, or patient-specific, each has its unique place in medical care."
Rafał ByczkowskiPersonalized medical devices
The question that can come up is, what sort of medical devices belong to “personalized medical devices”? The answer is that “personalized medical devices” cover the following groups of medical devices:
- patient-matched medical devices (also named as: patient-specific medical device),
- adaptable medical devices,
- custom-made medical devices.
The article presents particular definitions and allows you to gain knowledge so as to distinguish between “patient-matched devices” (also named as: “patient-specific devices”), “adaptable medical devices” and “custom-made medical devices”.
Another important question that can be asked is, what does the term “personalized medical device” exactly meant? Therefore, it is of great importance to understand the term: “personalized medical device”. I am very happy to explain that. “Personalized medical device“ is a generic term to describe any of the types of devices that are intended for a particular individual, which could be:
- either a custom-made,
- or adaptable,
- or patient-specific medical device.
Basic definitions
There are three groups of “personalized medical devices” referred above. Please let me present definitions for each of above mentioned group.
Custom-made device:
It is any device that:
- is specifically made in accordance with a written prescription of any person authorised by 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.
It is worth explaining the term: specific design characteristic. It is unique design specifications that are based on an individual’s specific anatomo-physiological features or pathological condition, and that cannot be proposed by a manufacturer without the involvement of a healthcare professional during the conception phase.
It is also worth explaining the term: written prescription. A written prescription must be issued by a qualified person authorised by national law. At minimum, it should contain:
- the name of the patient (or pseudonym if relevant),
- specific design characteristics made by the authorised person which are unique to the patient’s anatomic-physiological features and/or pathological condition.
Adaptable medical device:
It is a mass-produced medical device that must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions3 to suit an individual patient’s specific anatomo-physiologic features prior to use.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices.
The mass-produced device is a medical device that is based on standardized dimensions/designs; that is not designed for a particular individual; and that is typically produced in a continuous production run or homogenous batch.
| Biography Rafał Byczkowski, Regional Head Certifier for non-active devices at TÜV Rheinland, oversees the certification process for non-active medical devices, ensuring they meet the highest standards of safety and performance. With a tenure at TÜV Rheinland since September 1, 2011, Mr. Byczkowski brings a wealth of knowledge from his 17 years in the medical devices sector, particularly in the design, development, and manufacturing of orthopaedic implants and surgical instruments. Throughout his illustrious career at TÜV Rheinland, he has donned multiple hats, from being a decisive Certifier to a qualified Lead Auditor and Product Assessor/Specialist for non-active medical devices. His expertise and commitment to excellence have also earned him a place in the appointer team, responsible for authorizing new Auditors/Experts at TÜV Rheinland. |
Patient-matched medical devices (patient-specific medical device):
It is a medical device that meets the following requirements:
- it is matched to a 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,
- it is typically produced in a batch through a process that is capable of being validated and reproduced; and,
- it is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional.
If you are interested in examples of custom-made medical devices, adaptable medical devices or patient matched medical devices, please see MDCG 2021-3 guideline.
Conformity assessment procedure
Next issue that I would like to bring up is relevant conformity assessment procedure for custom-made medical devices.
Manufacturers of custom-made medical devices shall follow the procedure set out in Annex XIII of the Regulation (EU) 217/745 (MDR), and draw up the statement set out in Section 1 of that Annex before placing such devices on the market.
In addition, manufacturers of class III custom-made implantable devices shall follow conformity assessment procedure:
- specified in, Chapter I of Annex IX of the Regulation (EU) 217/745,
- alternatively, specified in Part A of Annex XI of the Regulation (EU) 217/745.
The question that can also be asked is, whether the involvement of the notified body is needed when a manufacturer wishes to produce custom-made medical devices. The answer is that a conformity assessment procedure covering Quality Management System certification by a notified body (in accordance with Chapter I of Annex IX or Part A of Annex XI of the Regulation (EU) 217/745,) is applicable to class III custom made implantable medical devices. As a result of such an involvement, relevant certificate (the Regulation (EU) 217/745) is issued.
In such a case, applicable for manufacturers of class III custom-made implantable medical devices horizontal code (pursuant to Regulation (EU) 2017/2185) is MDS 1013 - Class III custom-made implantable devices.
Example of custom-made medical device
Being aware on differences between particular medical devices belonging to “personalized medical devices”, I am truly happy to show you the following example.
The example is the implant that is designed and manufactured to be used for reconstruction of bone defect after a tumor resection of one individual patient (one individual medical case). Such an implant is considered as custom-made medical device. Justification for such a classification is:
- there is no other such an implant available on the market to fit this particular patient (because of shape, because of specific skull defect),
- it is made only for this particular individual patient (because of individual shape and size reflecting this particular tumor resection),
- it is not intended to be produced in homogenous batches (the only one implant having specific shape and size and being unique is to be produced),
- it is made on the request of an authorized healthcare professional,
- it is not the device to be adopted at the point of care to suit an individual patient’s specific anatomo-physiologic features prior to use. The implant in question is designed and manufactured to suit only particular patient after this particular tumor resection – it is not possible to adopt such an implant to suit any patient after any tumor resection.
Taking into account all of these above mentioned definitions, you can easily see that not of all “personalized medical devices” are considered as “custom-made devices” (including class III custom-made implantable medical devices) which are referred in the Regulation (EU) 217/745. Therefore, before classifying particular device as custom-made referred the Regulation (EU) 217/745 (including class III custom-made implantable medical device), I would like you to pay particular attention on above presented definitions because it shall be explicitly distinguished between adaptable medical device, patient-matched medical device and custom-made medical device.
Furthermore, in relation to class III custom-made implantable medical device, as presented above, intervention of the notified body is needed and relevant certification is required.
Last but not least, If you are interested in more details, I would like you recommend the following guideline documents:
- MDCG 2021-3: “Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices”,
- IMDRF: IMDRF/PMD WG/N49 FINAL:2018, ”Definitions for Personalized Medical Devices”.
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