On January 13th, 2023, the European Commission (EC) published an overview of the coverage of the designation codes by MDR and IVDR for Notified Bodies (NB). It shows us that currently for IVDs under the IVDR over 80% of the codes are covered by 7 out of 8 NBs.
An overview on the coverage of the designation codes by MDR/ IVDR Notified bodies.
Although this is good news, this is also a reminder that there is a wide disparity over the areas/codes for which the so far 8 Notified Bodies have been designated under IVDR. MDCG 2021-14 (Exploratory note on IVDR codes) explains the different levels of codes, established in Annex II of the Commission Implementing Regulation 2017/2185, 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 at the NB.
The following table presents an overview of the different types of codes and a summary of the main characteristics of each of them for the assignment to specific devices and the allocation of resources:
Type Code | Assignment of codes to the device | Relevance for allocation of the conformity assessment team |
IVR Codes reflect the design and intended purpose of the device | Exactly 1 code per device.* The code should be selected according to the order in Regulation 2017/2185. If more than 1 IVR code is applicable, the one that is first in the list should be selected. | Allocation of personnel involved in the review of technical documentation (e.g. product reviewers) or in audits concerning product related aspects. |
IVS Horizontal codes that reflect the specific characteristics of the device | 0 to several per device. Assign all codes applicable to the device. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. May also be applicable to staff performing audits concerning certain special processes.** |
IVT Horizontal codes that describe technologies | 1 to several per device Assign the codes which describe the main production technologies. Select once an IVR code has been assigned | Allocation of personnel involved in audits (e.g. site auditors involved in the auditing of metal processing). |
IVP Horizontal codes that describe knowledge in examination procedures | 1 to several per device*** Assign the codes which describe the main examination procedures. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. |
IVD Horizontal codes that describe knowledge in laboratory and clinical disciplines | 0 to several per device Assign the codes which describe the main laboratory and clinical disciplines. Select once an IVR code has been assigned. | Allocation of personnel involved in the review of technical documentation. |
* Note: Cases may exist in which more than one IVR code is assigned
** Note: Assessment of these processes could be performed by product reviewers or site auditors depending on their competence and the NB’s system
*** Note: Exceptional cases may exist that no IVP code is assigned (e.g. controls or specimen receptacles)
What does this mean to you?
This publication reminds us that there is a wide disparity over the areas/codes for which the Notified Bodies have been designated under MDR and IVDR. It is important for all manufacturers and acknowledges the importance to verify that your NB has the proper designation for the technologies you are (or will in the future) operating in.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.