이어서 아래의 MDR Annex I 내용은 EN ISO 14971 Content deviation 과 이어집니다.

[Annex I General safety and performance requirements]

1. eliminate or reduce risks as far as possible through safe design and manufacture;

2. where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and

3. provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.

Manufacturers shall inform users of any residual risks.

[EN ISO 14971:2012 Content deviations]

5. Discretion as to the risk control options/measures:

a) 6.2 of ISO 14971 obliges the manufacturer to "use one or more of the following risk control options

in the priority order listed:

(a) inherent safety by design;

(b) protective measures in the medical device itself or in the manufacturing process;

(c) information for safety" and leaves a discretion as to the application of these three options: shall the second or third control option still be used when the first was used? 6.4 indicates that further risk control measures do not need to be taken if, after applying one of the control options, the risk is judged acceptable according to the criteria of the risk management plan.

b) However, the second sentence of Section 2 of Annex I to Directive 93/42/EEC requests "to conform to safety principles, taking account of the generally acknowledged state of the art" and "to select the most appropriate solutions" by applying cumulatively what has been called "control options" or "control mechanisms" in the standard.

c) Accordingly, the manufacturer must apply all the "control options" and may not stop his endeavours if the first or the second control option has reduced the risk to an "acceptable level" (unless the additional control option(s) do(es) not improve the safety).

6. Deviation as to the first risk control option:

a) 6.2 of ISO 14971 obliges the manufacturer to "use one or more of the following risk control options in the priority order listed: (a) inherent safety by design ... " without determining what is meant by this term.

b) However, the first indent of the second sentence of Section 2 of Annex I to Directive 93/42/EEC requires to lIeliminate or reduce risks as far as possible (inherently safe design and construction)".

c) Accordingly, as the Directive is more precise than the standard, manufacturers must apply the former and cannot rely purely on the application of the standard.

7. Information of the users influencing the residual risk:

a) The residual risk is in 2.15 and in 6.4 of ISO 14971 defined as the risk remaining after application of the risk control measures. 6.2 of ISO 14971 regards "information for safety" to be a control option.

b) However, the last indent of Section 2 of Annex I to Directive 93/42/EEC says that users shall be informed about the residual risks. This indicates that, according to Annex I to Directive 93/42/EEC and contrary to the concept of the standard, the information given to the users does not reduce the (residual) risk any further.

c) Accordingly, manufacturers shall not attribute any additional risk reduction to the information given to the users.

[Annex I General safety and performance requirements]

5. In eliminating or reducing risks related to use error, the manufacturer shall: (a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and (b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

8. All known and foreseeable risks, and any undesirable side-effects, shall be minimized and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.

9.For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons

[EN ISO 14971:2012 Content deviations]

2. Discretionary power of manufacturers as to the acceptability of risks:

a) ISO 14971 seems to imply that manufacturers have the freedom to decide upon the threshold for risk acceptability/ and that only non-acceptable risks have to be integrated into the overall risk-benefit analysis,

b) However, Sections 1 and 2 of Annex I to Directive 93/42/EEC require that all risks have to be reduced as far as possible and that all risks combined, regardless of any "acceptability" assessment, need to be balanced, together with all other risks, against the benefit of the device,

c) Accordingly, the manufacturer may not apply any criteria of risk acceptability prior to applying

Sections 1 and 2 of Annex I to Directive 93/42/EEC.

4. Discretion as to whether a risk-benefit analysis needs to take place:

a) 6.5 of ISO 14971 says: "If the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk." Clause 7 of ISO 14971 says: "If the overall residual risk is not judged acceptable using the criteria established in the risk management plan, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk." Both quotes imply that an overall risk-benefit analysis does not need to take place if the overall residual risk is judged acceptable when using the criteria established in the risk management plan. Equally, 0.6.1 says: "A risk/benefit analysis is not required by this International Standard for every risk."

b) According to Section 1 of Annex I to Directive 93/42/EEC, an overall risk-benefit analysis must take place in any case, regardless of the application of criteria established in the management plan of the manufacturer. Furthermore, Section 6 of Annex I to Directive 93/42/EEC requires undesirable sideeffects to "constitute an acceptable risk when weighed against the performance intended".

c) Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.