My question is simple: can information for safety now be used to reduce risk? It seems apparent from the relevant sections of MDR and ISO 14971 below, but would like to get a confirmation from this community as this is a significant change from MDD deviation.
ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a) eliminate or reduce risks as far as possible through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c) provide information for safety (warnings/precautions/contraindications) and, where appropriate, training to users.
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
CHAPTER I
GENERAL REQUIREMENTS
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:
(a) eliminate or reduce risks as far as possible through safe design and manufacture;
(b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and
(c) provide information for safety (warnings/precautions/contraindications) and, where appropriate, training to users.
ISO 14971:2019
Section 7.1 Risk control option analysis
NOTE 2 Risk control measures can reduce the severity of the harm or reduce the probability of occurrence of the harm, or both.
Section 7.1 Risk control option analysis
NOTE 2 Risk control measures can reduce the severity of the harm or reduce the probability of occurrence of the harm, or both.