MDR - CE에서의 등급분류에 대해 Annex VIII 에서 설명하는 Classification Rules를 지난 회차에 이어 설명을 드립니다.

[변경사항]

Rule 11 - New Rule(Software)
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

- death or an irreversible deterioration of a person's state of health, in which case it is in class III; or

- a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.

Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

All other software is classified as class I.

진단 또는 치료 목적으로 의사결정을 내리는 데 사용되는 소프트웨어는 다음과 같은 상황을 발생시키는 경우를 제외하고 Class IIa로 분류된다.

- 환자의 건강상태가 사망 또는 회복 불능의 상태를 야기할 수 있는 경우 Class III,

- 환자의 건강상태 또는 외과수술에 대한 심각한 악화를 야기할 수 있는 경우 Class IIb

- 생리학적 단계를 감시하기 위한 목적의 소프트웨어는 Class IIa로 분류하며, 생리학적 파라미터의 변동이 환자에게 즉각적인 위험을 초래할 수 있는 경우는 Class IIb로 분류한다.

기타 다른 소프트웨어는 모두 Class I 으로 분류한다.

Rule 12 – 기존 Rule 11

Medicines -> medicinal products

Rule 13 – 기존 Rule 12

변경사항 없음.

Special Rules

Rule 14 – 기존 Rule 13

As defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive,

Rule 15 – 기존 Rule 14

변경사항 없음.

Rule 16 – 기존 Rule 15

2번째 문단:

All devices intended specifically to be used for disinfecting or sterilizing medical devices are classified as class IIb, unless they are disinfecting solutions or washer disinfectors intended specifically to be used for disinfecting invasive devices, as the end point of processing, in which case they are classified as class IIb.

3번째 문단:

Ÿ  Products -> devices

Ÿ  Medical devices -> devices

Ÿ  마지막 only 추가

Rule 17 – 기존 Rule 16

Intended for recording of X-ray diagnostic images
-> intended for recording of diagnostic images generated by X-ray radiation

Rule 18 – 기존 Rule 17

Animal tissues -> tissues or cells of human or animal origin

,which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.

Rule 19 - New Rule(Nanomaterials)

All devices incorporating or consisting of nanomaterial are classified as:

- class III if they present a high or medium potential for internal exposure;

- class IIb if they present a low potential for internal exposure; and

- class IIa if they present a negligible potential for internal exposure.

나노물질로 구성되거나 결합되는 모든 기기는 다음과 같이 분류한다.

-       내부 노출에 대한 높거나 중간의 잠재력이 있는 경우는 Class III

-       내부 노출에 대한 낮은 잠재력이 있는 경우 Class IIb

-       내부 노출에 대한 무시할 만한 잠재력의 경우는 Class IIa

Rule 20 ~ 22 – New Rules

혈액백에 대한 규칙은 Rule 2에서 확인할 수 있다.