The Medical Device Regulation (MDR) defines the “custom-made device” as any device which is specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics. A custom-made device is intended for the sole use of a particular patient. (MDR 2017/745 – Article 2 (3))
Examples of qualified medical practitioners: Dentist, Ophthalmologist, Orthotist, Ocularist.
Prerequisite to show experience of at least 2 years in manufacturing process
Example of custom-made devices: Orthopaedic footwear, Maxillofacial Prosthesis.
Special note: mass-produced devices which need to be adapted to meet the requirements of a healthcare professional, even though they are supplied for the sole use of a particular patient, are not considered as custom-made. (e.g., contact lenses).
Steps to place a custom-made device on the EU market:
Step 1: Non-EU Manufacturer appointing an Authorized Representative in Europe;
Step 2: Compliance with all the essential safety & health requirements that apply to the custom-made device (see compliance with MDR);
Manufacturers of custom-made devices shall:
- Comply with the essential requirements (MDR 2017/745 – Annex I)
- Shall establish, document, implement and maintain, keep up to date and continually improve a quality management system. (Article 10.9)
- Draw up Statement that the device conforms to the general safety and performance requirements (MDR 2017/745 – Annex XIII – section 1)
- Draw up technical documentation (MDR 2017/745 – Annex XIII – Section 2).
- PMCF as referred to in (MDR 2017/745 – Annex XIV, Part B)
- Report any Vigilance case (MDR 2017/745 – Article 87(1))
With the MDR, there is no longer pre-market notification of custom-made devices per se. However, it is likely that the commission will set-up guidelines in order to properly identify the market chain.
Custom-made devices do not bear the CE marking.
Custom-made devices do not require the intervention of a Notified Body.
A device may be placed on the market or put into service only if it complies with the Medical Device Regulation.
A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
Manufacturers and their Authorized Representatives shall cooperate with competent authorities to demonstrate the compliance of the device. If the manufacturer or authorized representative fails to cooperate or to provide complete or correct, the competent authority may take all appropriate measures to prohibit the device’s being made available on its national market, to withdraw the device from that market or to recall it.