Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745.
These codes are designed for use by European authorities to define the scope of Notified Body designations under the MDR, as well as by Notified Bodies themselves to indicate their staff qualifications as well as qualifications necessary for particular device assessments.
“These codes may be very broad and, furthermore, unequivocal authorization of personnel to codes and the assignment of codes to a device is not always straightforward,” states MDCG in the document. “However, the notified body’s system needs to ensure, in all cases, that the authorization of personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise.”
The document lays out three main code types:
When a manufacturer puts forward an application with notified body, the type of devices and technologies subject to conformity assessment activities are to be indicated. Notified bodies will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves, usually, at the application review stage. This verification is carried out in order to ensure that the notified body is able to assess the application based on its designation, and that it has available resources to carry out the relevant conformity assessment activities (feasibility evaluation). The final assignment is made by the NB.
After this application review, and signing of the contract, the notified body will allocate appropriately qualified and authorized personnel to carry out audit activities or product reviews.
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 device||Relevance for allocation of the conformity assessment team|
reflect design and intended purpose of device
|Exactly 1 code per device.
The codes should be selected according to their hierarchical order in Regulation 2017/2185. If more than 1 MDA/ MDN code is applicable, the one that is highest 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.|
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 MDN/MDA code has been assigned.
|Allocation of personnel involved in the review of technical documentation (e.g. product reviewers of sterilisation validation). May also be applicable to staff performing audits concerning certain special processes|
Horizontal codes that describe technologies or processes
|1 to several per device Assign the codes which describe the main production technologies or processes. Select once an MDN/MDA code has been assigned.||Allocation of personnel involved in audits (e.g. site auditors involved in the auditing of metal processing).|
Note: Assessment of these codes could be performed by product reviewers or site auditors depending on their competence.
MDA / MDN-codes reflect the design and intended purpose of the device and hence are mostly relevant for the allocation of personnel involved in the review of technical documentation. In some specific cases, the NB may assign product reviewers to assess product performance and safety aspects during an audit. This means that if there are product related issues to be audited and the auditors do not possess the required qualification, product reviewers who are qualified for the device in question should be part of the audit team. The NB needs to ensure that the personnel allocated to the project are competent to assess for the devices and technologies under assessment.
The MDA / MDN codes may either specify a field of medical application (e.g. MDA 0309 Active non-implantable ophthalmologic devices) or the physical or technological principle of the device (e.g. MDA 0302 Active non-implantable devices utilizing non-ionizing radiation or MDA 0315 Software). Therefore, there are cases where more than one specific code might apply to a device (e.g. surgical laser for refractive surgery of the eye). Also, where there is a broad intended purpose, several codes may apply. Having these issues in mind, when drafting the Regulation 2017/2185, the codes were put in order such that the MDA/MDN codes that require very specific technological knowledge and experience are highest in the code lists. Therefore, in cases where more than one MDA/MDN code apply, the code highest in the list is to be selected. This approach ensures consistent assignment of codes (and therefore consistent assignment of suitably qualified staff) to devices.
Devices may be composed of different “components” which, if they were products on their own, would belong to different MDA/MDN codes. In such cases, the intended purpose or the main physical or technological principle of the device should be considered. Nonetheless, the notified body needs to ensure that the assigned staff is qualified to assess all components of the device.
Note that, given the complexity and the diversity of medical devices, in exceptional cases deviations from the guidance given above may be necessary when assigning codes to devices in order to ensure suitably qualified staff in the conformity assessment. In such cases, a brief rationale shall be documented.
MDS codes are horizontal codes that are applicable to devices with specific characteristics. All codes that are applicable need to be assigned to a device in order to ensure that the review team possesses the full set of qualifications necessary for the conformity assessment. The MDS-codes are mainly relevant for the allocation of personnel involved in the review of technical documentation. This is because, generally, the auditing aspects linked to MDS codes have their corresponding MDT code for the relevant technology (e.g. MDS 1001 Devices incorporating medicinal substances vs MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals). However, MDS codes may also be applicable to staff performing audits concerning certain special processes (for example MDS 1005 for staff auditing ethylene oxide sterilization processes).
MDT codes relate to the technologies and processes that are used in the manufacturing and making available of the devices. MDT codes are relevant for the allocation of site auditors. Assignment of MDT codes should be done taking into consideration production of the device itself as well as for critical upstream production steps. This means that, even though many codes could be applicable when taking into consideration the processes involved in the entire supply chain of a medical device, these should not be considered for the use of MDT codes.
Conditions should be established by the notified body 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 this code. The designating authority could also apply conditions to the notified body’s designation where the notified body does not have sufficient competence to cover a given code or could seek designation for conformity assessment of only certain devices within a code.
Conditions, including limitations, should be formulated in an unambiguous way. Furthermore, since the technical codes basically mirror the competence system of the notified body, the conditions and limitations should concern device characteristics.
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