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MDRQ #1691

MDRQ #1690: ANNEX I GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

CHAPTER I GENERAL REQUIREMENTS

Added by Anonymous over 6 years ago.

Status:
Released
Priority:
Low

Description

CHAPTER I GENERAL REQUIREMENTS

Subissues

MDRQ #1692: 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.ReleasedActions
MDRQ #1693: 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.ReleasedActions
MDRQ #1694: 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.ReleasedActions
MDRQ #1695: 3. Manufacturers shall establish, implement, document and maintain a risk management system.ReleasedActions
MDRQ #1696: Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.ReleasedActions
MDRQ #1697: In carrying out risk management manufacturers shall:ReleasedActions
MDRQ #1698: (a) establish and document a risk management plan for each device;ReleasedActions
MDRQ #1699: (b) identify and analyse the known and foreseeable hazards associated with each device;ReleasedActions
MDRQ #1700: (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;ReleasedActions
MDRQ #1701: (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;ReleasedActions
MDRQ #1702: (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; andReleasedActions
MDRQ #1703: (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.ReleasedActions
MDRQ #1704: 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.ReleasedActions
MDRQ #1705: 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.ReleasedActions
MDRQ #1706: In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:ReleasedActions
MDRQ #1707: (a) eliminate or reduce risks as far as possible through safe design and manufacture;ReleasedActions
MDRQ #1708: (b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; andReleasedActions
MDRQ #1709: (c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.ReleasedActions
MDRQ #1710: Manufacturers shall inform users of any residual risks.ReleasedActions
MDRQ #1711: 5. In eliminating or reducing risks related to use error, the manufacturer shall:ReleasedActions
MDRQ #1712: (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), andReleasedActions
MDRQ #1713: (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).ReleasedActions
MDRQ #1714: 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.ReleasedActions
MDRQ #1715: 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.ReleasedActions
MDRQ #1716: 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.ReleasedActions
MDRQ #1717: 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.ReleasedActions

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