MDR에서는 EN ISO 14971:2012와 EN ISO 13485:2016 을 적용합니다.

위험(Risk)은 Article 2 에서 아래와 같이 정의됩니다.
 

The combination of the probability of occurrence of harm and the severity of that harm
 

이익-위험 분석(Benefit-Risk Determination) 또한 Article 2에서 아래와 같이 정의됩니다.

The analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer
 

Article 10 일반 의무사항에서는 Annex I, Section 3에서 설명하는 위험관리에 대한 시스템을 수립, 문서화, 실행 및 유지해야한다고 말합니다.
 

Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I

Annex I 일반 안전 및 성능 요구사항에서는 가능한 한 최소로 위험을 감소시켜야 합니다. 이 내용은 EN ISO 14971 규격 내에서도 content deviation 에서 확인이 가능합니다.
 

[Annex I General safety and performance requirements]

1.      Devices shall be safe and effective and shall not compromise … the health or the safety of patients, users or other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits … and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.
2.      The requirement … to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.

[EN ISO 14971:2012 Content deviations]

1.      Treatment of negligible risks
   1.      According to standard ISO14971, the manufacturer may discard negligible risks.
   2.     However, Sections 1 and 2 of Annex I to Directive 93/420EEC require that all risks, regardless of their dimension, need to be reduced as much as possible and need to be balanced, together with all other risks, against the benefit of the device.

3.      Risk reduction as far as possible versus as low as reasonably practicable.
   1.      Annex D.8 to ISO14971, referred to in 3.4, contains the concept of reducing risks “as low as reasonably practicable” (ALARP concept). The ALARP concept contains an element of economic consideration.
   2.     However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and carious particular Essential Requirements require risks to be reduced “as far as possible” without there being room for economic considerations.
   3.      Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations.

또한 Annex I 에서는 아래와 같이 제조자의 위험관리를 설명하고 있습니다. 이 내용은 또한 EN ISO 14971:2012 3.4 등으로 확인할 수 있습니다.
 

[Annex I General safety and performance requirements]

3.      Manufacturers shall establish, implement, document and maintain a risk management system.

Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.

Manufacturers shall:

1.      establish and document a risk management plan for each device;
2.     identify and analyse the known and foreseeable hazards associated with each device;
3.      estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
4.     eliminate or control the risks referred to in point (c);
5.      evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and
6.       based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4

[EN ISO 14971:2012 Content deviations]

1.   Risk management plan
2.   Identification of hazards

5. Risk evaluation

6. Risk control

9. Production and post-production information

이어서 계속됩니다.