MDR Custom made device (CMD)

 MDR Custom made devices definition,

‘custom-made device’ 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.

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

Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII and draw up the statement set out in Section 1 of that Annex before placing such devices on the market

Custom made device shall have available within their organisation at least one person responsible for regulatory compliance. (Article 15)

ANNEX XIII PROCEDURE FOR CUSTOM-MADE DEVICES

Manufacturer or its authorised representative shall draw up a statement containing all of the following information:

Retention period of the above statement is at least 10 years after the device has been placed on the market. For the implantable devices the period shall be at least 15 years.

Annex XIII Documentation

Competent national authorities shall check the manufacturer documentation which indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance.

Conformity assessment:

All classes except Class III custom-made implantable devices:

Annex XIII Documentation + Statement Annex XIII Section 1

Class III custom-made implantable devices:

Option 1: Annex XIII Documentation +Chapter I of Annex IX+ Statement Annex XIII Section 1

Option 2: Annex XIII Documentation + Annex XI Part A Production Quality Assurance + Statement Annex XIII Section

Post-market requirements :

• Review and document experience gained in the post-production phase, including from PMCF
• Implement appropriate means to apply any necessary corrective action
• Reporting of serious incidents and field safety corrective actions to the competent authorities (Article 87(1))

Click here  to know US FDA Custom  device.

Source:  REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC