MDR CODES (MDA/MDN/MDS/MDT)

1.?????Bu kodlar hangi ama? i?in kullan?lmaktad?r? / What is the purpose of using these codes?

Bu kodlar ?ncelikli olarak yetkili makamlar taraf?ndan onaylanm?? kurulu?un g?rev kapsam?n? tan?mlamak i?in kullan?l?r ancak ayn? zamanda onaylanm?? kurulu? taraf?ndan a?a??daki ama?larla da kullan?l?r:

1) Onayl? kurulu? personelinin bireysel niteliklerini tan?mlamak

2) Bir cihaz? de?erlendirmek i?in gereken kalifikasyonu tan?mlamak

Bu kodlar ?ok geni? olabilir ve ayr?ca, personelin kodlar i?in kesin olarak yetkilendirilmesi ve kodlar?n bir cihaza atanmas? her zaman kolay de?ildir. Ancak, onaylanm?? kurulu?un sistemi, her durumda,

bir cihaz?n uygunluk de?erlendirmesi i?in personel ve ekip tahsisi, yeterli bilgi ve uzmanl??? sa?lar.

These codes are primarily used by designating authorities to define the notified body scope of designation but they are also used by the notified body to:

1) describe the individual qualification of the NBs staff members

2) describe the qualification required for assessing a device

These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device is not always straightforward. However, the notified body’s system needs to ensure, in all cases, that the authorisation of

personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise.

2.?????MDN / MDA codes

Bu kodlar onayl? kurulu?lar i?in gereklidir. MDA / MDN kodlar?, cihaz?n tasar?m?n? ve ama?lanan amac?n? yans?t?r ve bu nedenle ?o?unlukla teknik belgelerin g?zden ge?irilmesine dahil olan personelin tahsisi ile ilgilidir.

MDN / MDA-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.

MDA/MDN kodlar? ya bir t?bbi uygulama alan?n? (?rn. MDA 0309 Active implante edilemeyen oftalmolojik cihazlar) ya da cihaz?n fiziksel veya teknolojik prensibini s?n?flar. Bu nedenle, bir cihaza birden fazla ?zel kodun uygulanabilece?i durumlar vard?r (?rne?in, g?zün refraktif cerrahisi i?in cerrahi lazer). Ayr?ca, geni? bir ama?lanan ama? oldu?unda, birka? kod ge?erli olabilir.

The MDA / MDN codes may either specify a field of medical application (e.g. MDA 0309 Active nonimplantable ophthalmologic devices) or the physical or technological principle of the device (e.g.MDA 0302 Active non-implantable devices utilising 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.

3.?????MDS codes

MDS kodlar?, belirli ?zelliklere sahip cihazlara uygulanabilen yatay kodlard?r. ?nceleme ekibinin uygunluk de?erlendirmesi i?in gerekli tüm niteliklere sahip oldu?undan emin olmak i?in ge?erli olan tüm kodlar?n bir cihaza atanmas? gerekir. MDS kodlar? esas olarak teknik belgelerin g?zden ge?irilmesine dahil olan personelin tahsisi ile ilgilidir.

?rne?in ;

1) MDS 1005 - Steril durumdaki cihazlar

2) MDS 1008 - ?nsan vücudunda tamamen veya büyük ?l?üde emilen veya k?smi olarak da??lm?? cihazlar

3) MDS 1001 -T?bbi maddeler i?eren cihazlar

?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.

1) MDS 1005 - Devices in sterile condition: because it is provided sterile,

2) MDS 1008 - Devices utilising [...] being wholly or mainly absorbed or locally dispersed

in the human body […]: because it is absorbed, and

3) MDS 1001 - Devices incorporating medicinal substances: because it contains an

antibiotic.

4.?????MDT Codes

MDT kodlar?, cihazlar?n üretiminde ve kullan?ma sunulmas?nda kullan?lan teknolojiler ve süre?lerle ilgilidir. MDT kodlar?, saha denet?ilerinin tahsisi ile ilgilidir.

?rnek olarak;

1)????MDT 2008 Temiz odalarda ve kontrollü ortamlarda üretimi ifade ediyor.

2)????MDT 2009 Hayvan veya mikrobiyal kaynakl? materyallerin i?lenmesi kullan?larak üretilen cihazlar? ifade ediyor

3)????MDT 2011 Etiketleme dahil paketleme gerektiren t?bbi cihazlar?n üretimini ifade ediyor.

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.

1) MDT 2008 Devices manufactured in clean rooms and associated controlled

environments, because the manufacturing of the implant after the heat treatment is

conducted in clean rooms,

2) MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin because the implant is made from animal bone

3) MDT 2011 Devices which require packaging, including labelling because the implant is packed and labelled.

Kod yap?s? MDCG 2019-14 te detayl? a??klanm??t?r. Kodlar?n detay? a?a??daki gibidir.

The code structure is explained in detail in MDCG 2019-14. The details of the codes are as follows.