Custom-made Medical Devices

Published On - February 14, 2021

ShareThoughts MDR CE MARKING, Medical Device, Resources

Custom-made medical devices’ means any device specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

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 authorized person shall not be considered to be custom-made devices;

The table below shows examples of device types, which might fall into the category of custom-made medical devices although some of the device types listed below will also be available as mass-produced, rather than custom-made medical devices.

Device Type Prescriber Manufacturer
Dental appliances Dentist Dental laboratories
Artificial Eyes/Cosmetic Shells Ocularist/Orbital Prosthetist Ocularist or Ocular Technician
Maxillofacial Prosthesis Medical Consultant or Prosthetist Prosthetist
Hearing Aid Inserts/Molds Medical Consultant, Audiology Technician or Hearing Aid Dispenser/Audiologist Insert Maker
In-the-Ear Aids Medical Consultant, Audiology Technician or Hearing Aid Dispenser/Audiologist Aid Manufacturer
Orthopedic Footwear Orthotist or Shoe fitter Shoemaker
Joint Replacement Implants (designed for a specific individual) Orthopedic Surgeon Implant Manufacturer
Prosthetics and Orthotics Rehabilitation Consultant, Orthopedic Consultant, Prosthetists or Orthotists Prosthetic and Orthotic Service Companies and Manufacturers
Procedure for Custom-made devices as per EU MDR:

Exemptions for Custom made Medical Devices:

× UDI System

× Clinical evaluation

× Summary of safety and clinical performance

 

Other considerations:

  • The Competent Authority has the authority to check Technical documentation to ensure conformity with EU MDR
  • Custom-made devices shall not be CE marked
  • No Notified Body intervention is required for custom-made medical devices

Note: There is no custom-made devices for IVDs

The article is Posted by Mr. Manoj Meghavaram, Sr. Consultant (EU Regulations). Readers can contact Mr. Manoj via Email: mm@i3cglobal.com