EU MDR and IVDR
GSPR 2 The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.
GSPR 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. In carrying out risk management manufacturers shall:
- Establish and document a risk management plan for each device;
- Identify and analyse the known and foreseeable hazards associated with each device;
- Estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;
- Eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;
- 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
- 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
GSPR 5 In eliminating or reducing risks related to user error, the manufacturer shall:
- 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
- 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 person, professional, disabled or other users).
EU MDR only
GSPR 22 Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons.
22.1 Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.
22.2 Devices for use by lay persons shall be designed and manufactured in such a way as to:
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- Ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,
- Reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and
- Reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.
22.3 Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
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- Can verify that, at the time of use, the device will perform as intended by the manufacturer, and
- If applicable, is warned if the device has failed to provide a valid result.
