Custom Made Medical Device CE Marking

Custom made medical devices (CMD) means any device specifically made in accordance with a written prescription of any person authorised 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.

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Custom Made Medical Devices
Custom Made Medical Devices

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?

UD

What are the requirements for a custom made medical devices manufacturer?

Annex XIII of the MDR is specifically designed to custom-made medical devices manufactures, while all non-custom-made devices require Technical Documentation (Annexes II and III of the MDR), including clinical evaluation, custom-made devices are exempt.

Custom-made medical devices manufactures must consider the traceability of the device throughout the design, manufacturing process, and performance of the device as per the intended use. The manufacturer is also obligated to follow post-production phase requirements.

Additional requirments for class III custom made implants

All high-risk custom-made medical device manufactures must comply with the specifications detailed in Annex XIII,  and also undergo a conformity assessment. as per Annex IX, Chapter I, or by following Annex XI, Part A.

What is NOT required for a custom-device manufacturer?

Custom-made devices are exempt from complying to the following

  • Unique Device Identification (UDI) system
  • EUDAMED Registration
  • Custom-made devices are not eligible for the CE marking for medical devices
  • Summary of safety and clinical performance
  • Competent Authority has the authority to check Technical documentation to ensure conformity with EU MDR
  • No Notified Body intervention is required for custom-made medical devices

Note: There is no custom-made In-Vitro Diagnostic Devices permitted as per IVDR 2017/746

The article is posted by Mr. Manoj Meghavaram, Sr. Consultant (EU Regulations). Manoj was in the regulatory service industry for more than 5 years working with multiple CMD Implant and general device manufactures.