Custom-made, adaptable and patient-matched devices clarified by the MDCG

The Medical Devices Coordination Group has recently issued an extremely interesting document: "MDCG 2021-3 Questions and Answers on Custom-Made Devices". With the aim of clarifying the regulatory framework of custom-made devices and following the contents of the international document Imdrf Personalized Medical Devices of 18 March 2020, the MDCG seeks to shed some light on three types of medical devices that may appear "similar" (although they are not) and for which classification is often very complex.

More specifically, starting from the definition of custom-made device, the document highlights its differences with two different categories of medical devices tailored to the single patient: adaptable and patient-matched devices. In this article, we will try to highlight the differences between the three types of medical devices.

Custom-made devices

Article 2(3)(c) Mdr provides that a custom-made device is:

• specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications;
• has specific design characteristics under that person’s responsibility;
• intended for the sole use of a particular patient exclusively to meet their individual conditions and needs

Therefore, a custom-made device is prescribed, conceived, designed and manufactured for that specific patient.

According to the approach set out in the Imdrf document, a custom-made device must be created when the specific needs of an individual cannot be met, or cannot be met at the appropriate level of performance by an alternative device available on the market. That is to say, the right solution cannot

The Q&A goes on to give examples such as: a dental prosthesis manufactured in accordance with a written prescription provided by a dentist that contains specific design features for a particular patient's individual condition; an orthosis manufactured in accordance with a written prescription containing specific design features to assist that specific patient in relation to neuromuscular or musculoskeletal impairment; prostheses of the hand intended to replace a lost body part and/or function, manufactured in accordance with a written prescription, where the physician provides the patient with the specific design features necessary to manufacture the device.

Personalized medical devices

On the other hand, the same Art. 2 para. 3 states in the second paragraph that so-called personalized devices for the individual patient cannot be qualified as custom-made medical devices but must be considered as mass-produced devices (i.e. produced in homogeneous batches - for a more precise definition see Imdrf Definitions for Personalized Medical Devices of 26 March 2018).

Adaptable medical devices

These are mass-produced medical devices that need to be adapted, adjusted, assembled or shaped at the point of care by a healthcare professional.

This process, which is aimed at adapting the medical device to the anatomical and physiological characteristics of a specific patient, must in any case take place in accordance with the manufacturer's instructions (Annex I, point 23).

This undoubtedly leads to greater attention being paid by manufacturers to the content of the instructions for use, which should include indications to allow personalization, obviously taking into account user knowledge (Annex I, point 22 and Annex I, point 23.1).

According to the document, the following can be considered adaptable

• certain spectacle frames and lenses (assembled together to form eyeglasses).
• wheelchairs
• hearing aids (otoplasty and amplifier).
• orthotic braces

The document specifies that the adaptation must take place at a "point-of-care" but does not explain the requirements of this process.

Further indications on this issue are provided by the above-mentioned document Imdrf Personalized Medical Devices of 18 March 2020 which explains that the point-of-care is usually a healthcare institution or a professional and that Member States can regulate this process according to three approaches:

• manufacturing under special arrangements
• implementation of Medical Device Production Systems (same document – Appendix 1)
• fully regulated manufacturing with same requirements as those applied by the manufacturer.

In this regard, it seems appropriate for national legislation to clarify the correct procedure to be followed by professionals who perform this activity within their point-of-care (opticians, orthopaedic technicians, hearing aid specialists).

Patient-matched medical-devices

Patient-matched medical devices are perhaps the most interesting category (also because they were not previously covered by the MDD).

According to the definition in the document "Imdrf Definitions for Personalized Medical Devices of 26 March 2018, it is a personalized medical device that meets the following requirements:

• is adapted to a patient's anatomy starting from a standard device model or within a specific design envelope using techniques such as device scaling based on anatomical references, or using full anatomical features from patient imaging;
• is typically produced in one batch through a process that can be validated and reproduced;
• is designed and manufactured under the responsibility of the manufacturer but "in accordance with the written instructions of any authorised person" (Art. 2 para. 3 sentence 2 MDR).

Clearly, the type of design input into the healthcare professional's prescription will vary depending on the medical device to be manufactured.

An example of this are medical devices produced through additive or subtractive manufacturing (so-called 3D printing).

It is important to remember that such medical devices remain entirely the responsibility of the manufacturer, who is accountable for the design, safety, performance and overall conformity of the device.

To summarise, there are two major categories.

Custom-made devices

created specifically for the individual patient, where it is not possible to meet clinical needs with a serial medical device.

Personalized medical devices

Subdivided into:

• Adaptable devices
  Serial devices adapted to the individual patient at a point of care
  
  
• Patient-matched devices
  Mass-produced devices tailored to an individual patient by a person qualified as a manufacturer, but based on a prescription from an authorised person.