یادداشت توضیحی MDCG در مورد کدهای IVDR

فهرست مندرجات

اولاً، مرجع متذکر می شود که پوشش کلیه تغییرات احتمالی که نرم افزار مورد استفاده در دستگاه های پزشکی می تواند مشمول آن باشد غیرممکن است، بنابراین راهنمای حاضر فقط رویکرد کلی را که باید اعمال شود توصیف می کند و توصیه هایی را ارائه می دهد که باید رعایت شوند تا از انطباق با این قوانین اطمینان حاصل شود. الزامات نظارتی قابل اجرا به طور خاص، رویکرد پیشنهاد شده توسط مرجع مبتنی بر ارزیابی دقیق تأثیر ناشی از تغییرات نرم افزاری مورد بحث بر ایمنی و عملکرد دستگاه است. با این حال، در موارد خاص، حتی تغییراتی که در ابتدا برای تأثیرگذاری بر عملکرد دستگاه در نظر گرفته نشده است، می تواند منجر به تغییرات قابل توجهی در نحوه عملکرد دستگاه پس از اجرای این تغییرات شود. از این رو، به منظور اطمینان از ایمنی بیماران و سایر افرادی که از دستگاه استفاده می کنند، و همچنین اثربخشی آن در هنگام استفاده برای هدف مورد نظر، سازنده دستگاه پزشکی باید تأثیر احتمالی این تغییرات را ارزیابی کند.

نکته مهم دیگری که آژانس به آن توجه ویژه ای دارد مربوط به ساختار نرم افزار است. بیان شده است که اگر نرم افزار مورد نظر از چندین ماژول تشکیل شده باشد، کمتر احتمال دارد که تغییرات جزئی بر عملکرد کلی نرم افزار تاثیر بگذارد. در عین حال، اگر نرم افزار مورد نظر ساختار واضحی نداشته باشد، چنین تغییراتی می تواند به طور قابل توجهی بر ایمنی و عملکرد دستگاهی که نرم افزار کار می کند تأثیر بگذارد.

بنابراین، بخشی از راهنمای FDA که در اینجا توضیح داده شده است، جنبه های مربوط به "نگهداری کد" و تغییرات "زیرساخت" را پوشش می دهد. علاوه بر این، این مرجع، تولیدکنندگان دستگاه های پزشکی (توسعه دهندگان نرم افزار) را تشویق می کند تا با بخش های مربوطه FDA تماس بگیرند تا تغییرات برنامه ریزی شده را با جزئیات بحث کنند.

نکات عمومی

First, the MDCG mentions that the assignment of the codes addressed herein sometimes is not straightforward. At the same time, these codes are intended to be used to ensure the designated staff which will conduct a conformity assessment of a medical device in question has the necessary qualifications. The document also provides a flowchart briefly describing the idea behind the codes to be assigned under the IVDR and the way they should be used by the parties involved in operations with medical devices.

According to the explanatory note, the code to be assigned should depend on the respective type of medical device based on the design of the device in question and its intended purpose as determined by the manufacturer. Additionally, such aspects as manufacturing processes and procedures should also be taken into consideration. The MDCG additionally emphasizes the importance of a multi-dimensional application of the codes described herein in order to ensure all elements (the medical device subject to review, the notified body duly designated to conduct conformity assessment of such devices, and designated staff having the necessary qualifications and knowledge) match each other.

The present explanatory note is intended to provide additional clarifications regarding the types of IVDR codes and how they should be used by the parties involved. The MDCG pays special attention to the aspects related to the designation of the staff, which will conduct an assessment of a medical device in question.

Assignment of Codes to IVDs

The explanatory note further describes the way the codes should be assigned to in vitro diagnostic medical devices in the course of the conformity assessment procedure. When the medical device manufacturers apply to the notified body for review, the latter should verify the codes assigned to a medical device in question or assign them themselves. In such cases, the codes are used to ensure that the notified body to which the manufacturer is applying is duly designated to conduct conformity assessments of medical devices of the particular type. Additionally, they will be used by the notified body to verify it has the necessary staff to review the application. It is also important to mention that in the case of any discrepancies in the assignment of codes, the one made by the notified body should be deemed final.

Upon completion of the application review, once the agreement between the medical device manufacturer and the notified body is signed, the latter will allocate dedicated specialists to engage in a conformity assessment.

The document published by the MDCG also contains a table describing the codes and specific aspects associated thereto.

Codes in Detail 

The present explanatory notice also provides detailed clarifications regarding some of the types of codes mentioned above. 

• IVR codes آنهایی هستند که 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. These codes could also be used by a notified body to allocate additional product reviewers having the necessary knowledge to assess the medical device subject to review. In general, these codes are intended to ensure that the staff involved in conformity assessment has the necessary knowledge and qualification. According to the guidance, the IVR codes may specify a field of in vitro diagnostic medical application. In certain cases, a device could have more than one code assigned. The MDCG also mentions that certain deviations from the general approach to the assignment of codes are allowed, provided such deviations are reasonably necessary due to the specific features of the device in question and are duly justified by the medical device manufacturer. Some in vitro diagnostic devices are “multiplexed,” i.e., contain several components. According to the document, such components should be covered by the same code. At the same time, if such components will be placed on the market as separate devices, they should have different codes. Thus, in exceptional cases, it is allowed to assign more than one code. 
• IVS codes هستند horizontal codes that are applicable to devices with specific characteristics. These codes are used to ensure the NB staff engaged in conformity assessment has the necessary knowledge and qualifications. First, they should be used when allocating personnel to be responsible for the review of technical documentation. 
• IVT codes are closely related to the technologies that are used in the manufacturing and making available of the devices. Such codes are used for the allocation of the auditors that will participate in on-site inspections of the manufacturing facilities. Thus, the assignment of such codes should be based not only on the characteristics of the medical device itself but also on the main elements of the manufacturing process. However, the MDCG explicitly mentions that only critical technologies and procedures should be taken into consideration when assigning such codes. This approach should be applied even if there are several medical device manufacturers participating in the manufacturing process. 
• IVP codes relate to the knowledge in examination procedures for the purpose of product verification. These codes are mostly used in the context of the designation of product reviewers. 
• IVD codes توصیف the knowledge in laboratory and clinical disciplines for the purpose of the product verification. They should also be used for the designation of product reviewers.   

In summary, the present explanatory notice published by the MDCG describes the main IVDR codes, their features, as well as the ways they should be assigned and used. The document provides detailed clarifications regarding each type of IVDR codes to be used to ensure the staff involved in conformity assessment has the necessary knowledge and qualification depending on the nature of a medical device subject to review. 

منابع:

https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021-14-guidance-ivdr-codes_en.pdf 

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