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