Guidance On Significant Changes Regarding The Transitional Provision Under Article 120 Of The MDR

MDR Madde 120(3) taraf?ndan sa?lanan ge?i? sürelerinden yararlanmak i?in, eski cihazlar?n tasar?m?nda veya kullan?m amac?nda MDR'nin uygulanma tarihinden, yani 26 May?s 2021'den sonra ?nemli bir de?i?iklik yap?lamaz.

In order to benefit from the transition periods provided by Article 120(3) MDR, legacy devices?may not undergo any significant change in the design or intended purpose after the date of?application of the MDR, i.e. 26 May 2021.

Tasar?mda veya ama?lanan ama?ta ?nemli bir de?i?iklik, kümülatif iki unsurdan olu?ur:

·???????tasar?mda veya ama?lanan ama?ta bir de?i?iklik olmas? ve

·???????de?i?ikli?in ?nemli olmas?

A significant change in the design or intended purpose consist of two cumulative elements:

?· there is a change in the design or intended purpose, and

· the change is significant

Bu, tasar?m? veya kullan?m amac?n? ilgilendirmeyen de?i?ikliklerin MDR Madde 120(3) kapsam? d???nda oldu?u anlam?na gelir. Ayn? ?ekilde, tasar?mla veya ama?lanan ama?la ilgili de?i?iklikler, yaln?zca "?nemli" kabul edilirlerse MDR Madde 120(3) kapsam?na girer.

That means that changes that do not concern the design or intended purpose are out of scope of?Article 120(3) MDR. Equally, changes that concern the design or intended purpose only fall?under Article 120(3) MDR if they are considered ‘significant’

Bir de?i?ikli?in tasar?m? veya kullan?m amac?n? etkilemedi?ine veya de?i?ikli?in cihaz?n tasar?m?n? veya kullan?m amac?n? etkilemesi durumunda ?nemsiz oldu?una ve duruma g?re de?erlendirilmesi gerekti?ine dair kan?t ve gerek?e sa?lamak üreticinin sorumlulu?undad?r. De?erlendirmenin sonucu belgelenmeli ve talep edildi?inde yetkili bir makama sunulmal?d?r.

The manufacturer is responsible for providing evidence and justification that a change does not?affect the design or intended purpose, or, in case the change affects design or intended purpose?of the device, that it is non-significant, which should be assessed case-by-case. The outcome of?the assessment should be documented and made available to a competent authority when?requested.

Bir de?i?ikli?in tasar?mda veya ama?lanan ama?ta ?nemli bir de?i?iklik olmamas? durumunda, b?yle bir de?i?iklikte MDR sertifikalanmas?na gerek yoktur.

If a change is not a significant change in design or intended purpose, the implementation of such?a change is allowed during the transitional period without the need for certification under the?MDR.

?nemli ve ?nemli olmayan de?i?ikliklere ?rnekler a?a??daki gibidir.

Examples of significant and Non-significant changes are as follows.

Non-significant change:

Examples:

·???????correction of an error which brings the device back to its original specification

·???????new or additional supplier/producer of a material within the defined specifications;

·???????substitution of a chemical substance in order to comply with other applicable laws and regulations e.g. REACH Regulation (EC) No 1907/2006;

·???????change of the sterilisation cycle parameters;

·???????extension of the shelf life validated by protocols approved by the notified body;

·???????new sterilisation vendor or chamber;

·???????change from single sterile to double sterile packaging.

Note: These examples are valid only provided that the risk/benefit ratio of the device is not negatively affected.

Significant change:

·???????Extension of the intended purpose, such as:

o??additional or new indications;

o??additional or new clinical conditions.

·???????New user or patient population, such as:

o??additional or new target population;

o??additional or new user (e.g. change from professional use to layman use).

·???????change to a material or substance which is part of an implant and intended for direct or indirect contact with patient tissue or fluid for more than 30 days, or is part of a surgically invasive device which is absorbed;

·???????addition or change of a material of human/animal origin (e.g. collagen produced from skins by collagen produced from bones)

·???????change of the terminal sterilisation method (e.g. ETO to Gamma);

·???????change (e.g. of the device) which adversely affects the sterility assurance level;

·???????hange in packaging design which affects sterility, stability or microbiological state of the device, including seal integrity;