What you need to know when manufacturing custom-made medical devices
Medical devices, and specifically implants, tend to become more and more patient-specific. Read here what the difference between a custom-made device and an off-the-shelf medical device is.
What is a custom-made device
A custom-made medical device is a device manufactured based on a written prescription of a health care professional (HCP) and with specific features or design characteristics intended for a specific patient to treat the individual condition. So, a custom-made device can be a modified regular device to meet the patient’s individual condition. For example, a manufacturer produces regular tibia implants to restore broken tibiae. The regular design holds locking holes in proximal and distal positions. The patient to be treated, however, needs additional locking holes as the bone is fractured in a specific way and only by the help of the additional locking holes, the tibia can be restored. These locking holes, their position and dimensions are stated by the HCP and are in the responsibility of the HCP.
Such a device would most probably be considered a custom-made device.
Producing custom-made devices on a regular basis
Producing custom-made devices on a regular basis is not prohibited per se. Instead, custom-made devices are understood as such as long as the manufacturing of the same device is not mass produced. Even though there is no clear definition of “mass production” by means of how many devices of the same type are to be manufactured in a certain period of time, the Notified Bodies (NB) will most certainly rule on this. As a fair judgement, producing more than 5 of the same implant might be considered a mass produced device.
What is an off-the-shelf device
A mass-produced, off-the-shelf device is a device which is offered from a catalogue or on a regular basis to patients. Such devices don’t require a prescription or a specific patient but can be offered on large scale. Often and predominantely with implants, a series of dimensions matching the different anatomical features over a range of patients is offered as devices. Such devices, differening in the dimensions or design characteristics are not understood to be custom-made devices. These devices are manufactured in large scale in the same manner as the most often sold implant of this range.
Is there a benefit in either one?
Comparing the benefits of both types of devices reveals that the custom-made devices have less burden on the documentation, as safety has to be shown apart from a CE-marking. In fact, a custom-made device needs to be compliant to Annex XIII of the MDR 2017/745. The con’s of such an approach is that a Notidied Body or Competent Authority could rate the company as regular medical device manufacturer and stopping the company from manufacturing custom-made devices.
On the other hand, the benefits of manufacturing regular medical devices in a mass production setting forces the company to show compliance to MDR. As a consequence of mass production, the company might be more profitable over a custom-made manufacturer.
The benefit in either approach might rather be a business decision than a decision from a regulatory point of view.