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MDCG offers guidance on IVDR codes

Posted 13 July 2021 | By Michael Mezher 

MDCG offers guidance on IVDR codes

The European Commission’s Medical Device Coordination Group (MDCG) on Tuesday released a document explaining the use of codes under the In Vitro Diagnostic Regulation (IVDR).
 
MDCG says the explanatory note “is intended to explain the different levels of codes and how they should be used, including the use of conditions to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.”
 
The codes, which are established under Commission Implementing Regulation 2017/2185 for both devices and IVDs, are used to describe the scope of a notified body’s designation, as well as to describe the individual qualification of notified body staff members and to describe the qualification required for assessing a device.
 
“It is acknowledged that these codes may be broad, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device may not always be straightforward. However, the [notified body’s] system needs to ensure, in all cases, that the authorisation of personnel and allocation of teams for the conformity assessment of a device ensures adequate knowledge and expertise,” MDCG writes.
 
The list of codes for IVDs is found in Annex II of Regulation 2017/2185 and are broken up into categories reflecting the design and intended purpose of the device and horizontal codes reflecting IVD characteristics, technologies or specific knowledge required for the purpose of product verification.
 
“These lists of codes should be used in a way which allows a multi-dimensional application to all typology of devices. This will ensure that [notified bodies] as well as the personnel assigned to conformity assessment are fully competent for the devices they are required to assess,” MDCG writes.
 
Within the document, MDCG presents each type of code and explains how it should be applied and how many of each code can or should be assigned to each device. For instance, the “IVR” code reflecting the design and intended purpose of the device should be used exactly once per device, while the “IVD” horizontal codes describing the knowledge in laboratory and clinical disciplines required in the examination procedure may be used zero to several times per devices.
 
The document also provides examples of how the codes would be used with specific types of devices. For instance, a blood glucose meter used for self-patient testing that contains incorporated software to measure glucose levels in the bloodstream would be assigned the following “IVS” codes, which relate to specific product characteristics:
  • IVS 1002: Devices intended to be used for self-testing
  • IVS 1008: Instruments, equipment, systems of apparatus
  • IVS 1010: devices incorporating software/utilizing software/controlled by software
Additionally, the document explains that notified bodies should establish conditions for individual codes “where the qualification of the staff authorised to a certain code is not sufficient to cover the entire spectrum of the devices within this code.” Likewise, designating authorities may apply conditions to a notified body’s designation reflecting a lack of competence for a specific code.
 
MDCG says that conditions should be formulated unambiguously, and that “since the technical codes mirror the competence system of the [notified body], the conditions and limitations should concern device characteristics. The experience and competence of the [notified body] may for example be limited due to the range of devices assessed under the [In Vitro Diagnostic Medical Devices Directive] IVDD.”

 

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