The Medical Device Authority (MDA) has released a new guidance as via the first edition of MDA/GD/0064: Notification of Custom-Made Medical Devices. Custom-made medical devices are intended to meet the demands and requirements of specific persons with specific design, in circumstances where commercially available items or alternative therapies are inadequate. It is the manufacturer's responsibility to guarantee that custom-made medical devices are safe and function well.

The new guideline contains several important key points:

1. 1. Custom-made medical device shall meet the following requirements:
   1. a) Designed solely for the use of a specific patient.
   2. b) Created in compliance with a signed prescription of medical practitioner / healthcare professional and with certain design characteristics stated in the request.

2. 2. The guidance provides requirements that need to be followed by the manufacturers:
   1. a) Requirements for the manufacturers
      1. i. Should verify that the special medical devices sold on the market adhere to the standards and shall meet the following custom-made medical device criteria: obtaining a written prescription and particular design characteristics from a medical practitioner / healthcare professional,
      2. ii. Applied relevant classification, demonstrated according to the First Schedule of the Medical Device Regulation (MDR) 2012.
      3. iii. Safe and performs as intended.
   2. b) Requirements for written prescription
      1. i. A medical practitioner / healthcare professional must issue a written prescription.
      2. ii. It must include at the very least: The name of the particular patient,  specific design characteristics, planned surgery date or medical device application date (if applicable).
   3. c) The Manufacturer shall submit a statement of the custom-made medical device.
      1. i. The statement shall include:

• - Data allowing identification of the device.
• - Section indicating that the item is intended for a specific patient, along with the individual's name.
• - The name of the medical practitioner / healthcare professional that requestes the device, as well as their healthcare facility, if relevant.
• - Specific design characteristics provided in the request by that medical practitioner / healthcare professional.
• - The name and address of the manufacturer.

3. 3. Each notification shall be submitted together with a RM 300 administrative charge. Turn-around time per application is 14 days upon submission of the completed form and supporting documents. The additional information requested by the Authority shall be provided within 30 working days.

4. 4. Advertisement of custom-made medical device is not allowed.
   1. More information and details can be found in the First Edition Guidance Document “Notification Of Custom-Made Medical Device” (MDA/GD/0064) included in the reference below.

 

 

References:
First Edition Guidance Document “Notification Of Custom-Made Medical Device” (MDA/GD/0064)