How Notified Bodies Must Ensure Appropriately Qualified Staff Assess Each IVD
Notified bodies must have a system in place to ensure that IVD devices are assessed by individual staff and teams with adequate knowledge and expertise. EU guidance explains the criteria for notified bodies.
The European Commission’s Medical Device Coordination Group has published a 17-page guidance document on IVD Regulation codes, MDCG 2021-14, to help notified bodies assign fully competent staff to the devices they are required to assess.
The guidance expands on Commission Implementing Regulation 2017/2185, which lists codes and the corresponding types of device for specifying notified body scopes under both the Medical Device Regulation and the IVDR.
2017/2185 established codes primarily used by designating authorities to define the notified body scope of designation, but they are also designed to be used by notified bodies to:
- Describe the individual qualification of the organization’s staff members; and
- Describe the qualification required for assessing a device with a given code.
MDCG acknowledges that the decisions around allocating staff to devices may not always be straightforward. But notified bodies must have a system in place to ensure that devices are assessed by personnel and teams with “adequate knowledge and expertise,” it stresses.
Different Levels Of Codes
MDCG 2021-14 is intended to explain the different levels of codes and how they should be used. It lays out conditions to ensure harmonized use of the codes, especially for the allocation of resources to conformity assessment activities.
In terms of processes, notified bodies must either verify the manufacturer assignment of codes to devices, or they must assign codes to the devices themselves. This is a key factor in the notified body then assessing if it has the available resources to carry out the relevant conformity assessment activities.
Furthermore, conditions should be established by the notified bodies themselves for individual codes in cases where the qualification of the staff authorized to a certain code is not sufficient to cover the entire spectrum of the devices within that code. These conditions would limit the scope of activity within a given code.
Also, the designating authority can apply conditions to the notified body’s designation where the organization does not have sufficient competence to cover a given code or notified bodies can seek designation for conformity assessment of only certain devices within a code.
MDCG states that conditions “should be formulated in an unambiguous way” and that “since the technical codes mirror the competence system of the notified body, the conditions and limitations should concern device characteristics.” Moreover, where there are limitations, these should be applicable to all types of codes.
It adds that the experience and competence of the notified body may, for example, be limited due to the range of devices assessed under the IVD Directive.
The document also features a table providing specific clarifications about which devices are covered and specific conditions under individual codes.