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# Regulation Type Subject Status
1673 MDR Database MDRQ ANNEXES Released
1692 MDR Database MDRQ 1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. Released
1693 MDR Database MDRQ They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. Released
1694 MDR Database MDRQ 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. Released
1695 MDR Database MDRQ 3. Manufacturers shall establish, implement, document and maintain a risk management system. Released
1696 MDR Database MDRQ Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. Released
1697 MDR Database MDRQ In carrying out risk management manufacturers shall: Released
1698 MDR Database MDRQ (a) establish and document a risk management plan for each device; Released
1699 MDR Database MDRQ (b) identify and analyse the known and foreseeable hazards associated with each device; Released
1700 MDR Database MDRQ (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse; Released
1701 MDR Database MDRQ (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4; Released
1702 MDR Database MDRQ (e) 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 Released
1703 MDR Database MDRQ (f) 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. Released
1704 MDR Database MDRQ 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. Released
1705 MDR Database MDRQ 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. Released
1706 MDR Database MDRQ In selecting the most appropriate solutions, manufacturers shall, in the following order of priority: Released
1707 MDR Database MDRQ (a) eliminate or reduce risks as far as possible through safe design and manufacture; Released
1708 MDR Database MDRQ (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and Released
1709 MDR Database MDRQ (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users. Released
1710 MDR Database MDRQ Manufacturers shall inform users of any residual risks. Released
1711 MDR Database MDRQ 5. In eliminating or reducing risks related to use error, the manufacturer shall: Released
1712 MDR Database MDRQ (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 Released
1713 MDR Database MDRQ (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). Released
1714 MDR Database MDRQ 6. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions. Released
1715 MDR Database MDRQ 7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. Released
1716 MDR Database MDRQ 8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised 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. Released
1717 MDR Database MDRQ 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. Released
1719 MDR Database MDRQ 10. Chemical, physical and biological properties Released
1720 MDR Database MDRQ 10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Released
1721 MDR Database MDRQ Particular attention shall be paid to: Released
1722 MDR Database MDRQ (a) the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability; Released
1723 MDR Database MDRQ (b) the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion; Released
1724 MDR Database MDRQ (c) the compatibility between the different parts of a device which consists of more than one implantable part; Released
1725 MDR Database MDRQ (d) the impact of processes on material properties; Released
1726 MDR Database MDRQ (e) where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand; Released
1727 MDR Database MDRQ (f) the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance; Released
1728 MDR Database MDRQ (g) surface properties; and Released
1729 MDR Database MDRQ (h) the confirmation that the device meets any defined chemical and/or physical specifications. Released
1730 MDR Database MDRQ 10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Released
1731 MDR Database MDRQ Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure. Released
1732 MDR Database MDRQ 10.3. Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use. Released
1733 MDR Database MDRQ 10.4. Substances Released
1734 MDR Database MDRQ 10.4.1. Design and manufacture of devices Released
1735 MDR Database MDRQ Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. Released
1736 MDR Database MDRQ Devices, or those parts thereof or those materials used therein that: Released
1737 MDR Database MDRQ ' are invasive and come into direct contact with the human body, Released
1738 MDR Database MDRQ ' (re)administer medicines, body liquids or other substances, including gases, to/from the body, or Released
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