Medical Device Requirements
The requirements, or general safety and performance requirements under Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR), are generally described as the need to fulfil the intended purpose specified by the manufacturer with the highest possible degree of safety and effectiveness.
The products will not compromise the clinical condition or safety of patients, and the possible residual risks will always be acceptable in relation to their benefit, that is, always maintaining a positive risk-benefit ratio.
Manufacturers must design, implement, document, and maintain a risk analysis and management system:
- Risk management plan for each product.
- Analysis of known and foreseeable risks for each product.
- Risk assessment in the intended use and in the foreseeably improper use.
- Assessment of the impact of the information collected by the monitoring system.
- It shall amend the control measures based on the previous impact assessment.
The risk control measures adopted by manufacturers for the design and manufacture of products shall be in accordance with the principles of safety, taking into account the state of the art, managing the residual risk until they are considered acceptable:
- With safe design and manufacturing, risks will be eliminated or reduced.
- Appropriate protection measures shall be adapted against risks that cannot be eliminated.
- Safety information, including user training, will be provided if necessary.
- Manufacturers shall inform users of residual risks.
By eliminating or reducing the risks associated with errors of use, the manufacturer will:
- It will reduce risks related to the ergonomics and intended environment of the product.
- It shall take into account the technical knowledge, experience, education, training and environment of use of the users, as well as their medical and physical condition.
During the life of the product, the characteristics and its operation will not pose a danger to patient safety under normal conditions of use and maintenance.
The products shall be designed, manufactured and packaged in such a way that transport and storage do not pose a risk.
All known and foreseeable risks, including undesirable side effects, shall be reduced and acceptable in relation to the benefit.
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