Custom made medical devices

This page is for hospitals and healthcare professionals.

It describes:

  • What a custom-made medical device (CMD) is.
  • Why it is important to distinguish CMDs from CE marked devices.

What are custom made medical devices?

CMDs are defined under the Medical Devices Regulation (MDR).

Under this definition, CMDs have several key considerations. These are summarised below.

ItemDescription
Basis CMDs are made according to a written prescription.
PrescriberThe prescription must come from a person authorised by national law based on their professional qualifications.
DesignThe authorised person provides specific design characteristics.
Intended useCMDs are for the sole use of a particular patient and must exclusively meet that patient's individual conditions and needs.

What is not a custom made device?

The definition specifically excludes:

  • Mass-produced devices needing adaptation, i.e. devices made in large quantities that only require adaptation for a professional user's requirements.
  • Mass-produced prescribed devices, i.e. devices made through industrial manufacturing processes even if they follow a written prescription from an authorised person.

Why is it important to distinguish CMDs from CE marked devices?

The conformity of CMDs is assessed under a different procedure to CE marked devices. This procedure is outlined under Annex XIII of the MDR.

CMDs require different documentation compared to CE marked devices.

It is important for entities to ensure their compliance verification procedures account for CMDs. 

What documentation should be checked for CMDs?

All CMDs require an Annex XIII statement.

Annex XIII outlines the requirement for manufacturers of CMDs to produce a statement with specific information.

When sourcing any CMD, including Class III implantable CMDs, hospitals should request a copy of an Annex XIII statement.

The information in an Annex XIII statement is summarised below.

InfromationDetails

Manufacturer & sites 

Name and address of the manufacturer, and all manufacturing sites. 

Authorised representative 

Name and address of the authorised representative, if applicable. 

Device identification 

Data allowing identification of the device in question. 

Statement of use 

A statement that the device is intended for exclusive use by a particular patient or user, identified by name, acronym, or numerical code. 

Prescriber details 

The name of the person who made out the prescription and is authorised by national law to do so, and, where applicable, the name of the health institution concerned. 

Product characteristics 

The specific characteristics of the product as indicated by the prescription. 

Conformity statement 

A statement that the device conforms to the general safety and performance requirements set out in Annex I. 

Non-conformity 

Where applicable, indicating which general safety and performance requirements have not been fully met, along with the grounds. 

Medicinal substance/tissues 

Where applicable, an indication that the device contains or incorporates a medicinal substance (including a human blood/plasma derivative) or tissues/cells of human or animal origin (as referred to in Regulation (EU) No 722/2012). 

HPRA webinar on custom made devices

For more detailed information on how the MDR applies to CMDs, please review our CMD webinar.