Thus, the changes by the MDR have not significantly shifted the approach, but the scope and the details of the requirements have increased considerably. &. 16.2The medium, format, content, legibility, and location of the label and instructions for use should be appropriate to the particular medical device, its intended purpose and the technical knowledge, experience, education or training of the intended users. Š Š ÿÿÿÿ 8 N „ Ò "X ª î! Essential Principles Applicable to All Medical Devices . 5. through the preparation and holding of technical documentation that shows how each IVD medical device was developed, designed and manufactured together with the descriptions and explanations necessary A Sample of the Completed Essential Principles Conformity Checklist MD-CCL. Access Free Medical Devices Essential Principles Checklist compilations in this website. 21.1.2Medical devices should be designed and manufactured in such a way that they can be used safely with the materials, substances, and gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they should 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.21.1.3Medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks, linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only.21.2.1Implantable medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks connected with medical treatment (e.g. GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of Medical Devices. For a medical device to be supplied in South Africa, it must be demonstrated that the relevant Essential Where a medical device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information should be understandable to the user and, as appropriate, the patient.Essential Principles – Labelling and Instructions for Use16.1Each medical device should be accompanied by the information needed to identify the medical device and its product owner. The shelf-life of these medical devices should be determined by validated methods. Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance: Medical Device and FDA Regulations and Standards News: 0: Sep 5, 2019: IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen surface properties; and the confirmation that the device meets any defined chemical and/or physical specifications.10.2The medical device should be designed, manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to patients, taking account of the intended purpose of the product. Devices should incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source. ergonomic features, tolerance to dust and humidity) and give consideration to the technical knowledge, experience, education, training and use environment and, where applicable, the medical and physical conditions of intended users.The characteristics and performances of a medical device should 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 expected lifetime of the device, as indicated by the product owner, when the medical device is subjected to the stresses which can occur during intended conditions of use and has been properly maintained and calibrated (if applicable) in accordance with the product owner’s instructions.Medical devices should be designed, manufactured and packaged in such a way that their characteristics and performances, including the integrity and cleanliness of the product and when used in accordance with the intended use, are not be adversely affected under transport and storage conditions (for example, through shock, vibrations and fluctuations of temperature and humidity) taking account of the instructions and information provided by the product owner. A Proposed Document was released by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group. Particular attention should be paid to: hazardous situations and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk determination 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 points 3 and 4 below.Risk control measures and outcomes adopted by the product owner for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. These principles protect the rights, safety and well-being of human subjects, which are the most important considerations and shall prevail over interests of science and society. Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that … Where applicable, the limits of accuracy should be indicated by the product owner. The performance, safety and sterility of the medical device should be maintained throughout any shelf-life specified by the product owner.Medical devices should have the stability necessary to maintain essential performance conditions in a period of time and conditions previously established during the shelf-life, during the time of use after being opened (for IVDs, including after being installed in the instrument), and during transportation or dispatch when under conditions other than storage conditions.All known and foreseeable risks, and any undesirable side-effects, should be minimized and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the medical device during intended conditions of use taking into account the generally acknowledged state of the art.Essential Principles – Clinical Evaluation9.1Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles. Essential Principles of Safety and Performance. In carrying out risk management, product owners should: establish and document a risk management plan for covering each medical device; identify and analyse the known and foreseeable hazards associated with each medical 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 points 3 and 4 below; evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on. 11.5Medical devices intended to be sterilised, either by product owner or user, should be manufactured and packaged in appropriate and controlled (e.g. When risk reduction is required, the product owner should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable. Essential Principles – Protection against electrical risks, mechanical and thermal risks17.1Medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks of accidental electric shocks to the user or any other person, during normal use and in single fault condition, provided the medical device is installed and maintained as indicated by the product owner.17.2Medical devices should be designed, manufactured and maintained in such a way as to provide an adequate level of cybersecurity against attempts to gain unauthorised access.17.3Medical devices should be designed and manufactured in such a way as to protect, as far as possible and appropriate, against unauthorized access that could hamper the device from functioning as intended or impose a safety concern.17.4Medical devices should be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance to movement, instability and moving parts.17.5Medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks arising from vibration generated by the medical device, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.17.6Medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks, arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.17.7Medical devices should be designed and manufactured in such a way as to eliminate or reduce, as low as reasonably practicable and appropriate, the risks of error when certain parts within the device are intended to be connected or reconnected before or during use.17.8Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle should be designed and constructed in such a way as to minimise all possible risks.17.9Medical devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings should not attain potentially dangerous temperatures under intended conditions of use.Essential Principles – Protection against radiation18.1Medical devices should be designed and manufactured and packaged in such a way that exposure of patients, users and other persons to any emitted radiation should be eliminated or reduced, as low as reasonably practicable and appropriate, compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.18.2The operating instructions for medical devices emitting hazardous or potentially hazardous radiation should give detailed information as to the nature of the emitted radiation, means of protecting the patient, user and others, and on ways of avoiding misuse and of eliminating the risks inherent to transport, storage and installation, as far as possible.18.3Where medical devices are intended to emit potentially hazardous, visible and/or invisible radiation, they should be fitted, where practicable, with visual displays and/or audible warnings of such emissions.18.4Medical devices should be designed and manufactured in such a way that the exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as low as practicable and appropriate.18.5Medical devices emitting ionising radiation intended for diagnostic radiology should be designed and manufactured in such a way as to achieve appropriate image and/or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user.18.6For medical devices emitting hazardous or potentially hazardous radiation and that require installation, information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure should be specified in the operating instructions.18.7Medical devices intended to emit hazardous or potentially hazardous ionising and/or non-ionising radiation should be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and energy distribution (or quality), and other key characteristics of the radiation emitted can be varied and controlled, and where appropriate, monitored during use, taking into account the intended use. î! Any restrictions on use applying to such combinations should be indicated on the label and/or in the instructions for use.12.5Any measurement, monitoring or display scale should be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the medical devices are intended to be used.12.6Medical devices must be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of any waste substances by the user, patient or other person. The SPRs are detailed in Annex I of the MDR. Some medical devices should include separate information for the professional user and the lay person. device to the Essential Principles of Safety and Performance of Medical Devices (hereafter referred to as Essential Principles) through the preparation and holding of technical documentation that shows how each medical device was developed, designed and manufactured together with the descriptions and explanations necessary to understand the The product owner is required to retain information on the geographical origin of the animals. In particular, safety with regards to viruses and other transmissible agents should be addressed by implementation of validated state of the art methods of elimination or inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the medical device.20.2For products that incorporate tissues, cells, or substances of human origin or their derivatives as medical devices, the following should apply: donation, procurement and testing of the tissues and cells should be done in accordance with jurisdictional requirements; and processing, preservation and any other handling of those tissues and cells or their derivatives should be carried out so as to provide safety for patients, users and, where applicable, other persons. Particular attention should be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.10.3The devices should be designed and manufactured in such a way as to reduce as far as reasonably practicable and appropriate the risks posed by substances that may leach or leak from the device.10.4The medical device should be designed and manufactured in such a way as to reduce as far as reasonably practicable and appropriate risks posed by the unintentional ingress into the device taking into account the device and the nature of the environment in which it is intended to be used.Essential Principles – Sterility, Packaging and Microbial contamination11.1Medical devices and their manufacturing processes should be designed in such a way as to eliminate or to reduce as far as reasonably practicable and appropriate the risk of infection to patients, users and, where applicable, all other persons who may come in contact with the medical device. specimens); and reduce as low as reasonably practicable and appropriate the risks from unintended exposure (e.g. Common mistakes to avoid, and the proposed EU regulations are also discussed. – Medical devices need to be suitable for the intended purpose. How to access a pdf or Word document. GENERAL PRINCIPLES. To illustrate the extent of the change: the essential requirements of the MDD are divided into 2 chapters with only 13 sub items. rapid development cycles, frequent changes, the cumulative effect of changes), risk management (e.g. Access Free Medical Devices Essential Principles Checklist and Improved Clinical Outcomes; and Pay for Performance: A Business Strategy for Quality Improvement in Neonatal-Perinatal Medicine. Essential principles checklist (medical devices) 17 September 2019. with implants), the risks from ageing of materials used, will be eliminated or reduced, as low as reasonably practicable and appropriate). When we start to discuss about the chemical, physical and biological properties of the medical device, we often spoke about the choice of material used, its biocompatibility status, duration of exposure to human body, possibility of leeching, ingress and egress of substances. A medical device is to be designed and produced in a way that ensures that: (a) the device will not compromise the clinical condition or safety of a patient, or the safety and health of the user of any other person, when the device is used on a patient under the conditions and for the purposes for which the device was … The individual columns in the below table have the following meaning: Ref. If you are working with medical devices such as drug-eluting stent and antibiotic bone cements, this section becomes especially important because of its long-term use within the patient. ä a ôc B ¹' Ñ+ ( ù+ ù+ ù+ $- º Ş0 ú1 � yc {c {c {c {c {c {c 6f ¢ Øh x {c Š2 $- $- Š2 Š2 {c ù+ ù+ + �c ( $4 $4 $4 Š2 ù+ ù+ yc $4 Š2 yc $4 $4 º •[ È ¡` ù+ ÿÿÿÿ @‘OÏ8ÁÍ a �3 ]^ J ec ¸c. These principles shall be understood, observed, and applied at every step in the clinical investigation.Essential Principles – Chemical, physical and biological properties10.1The medical devices should be designed and manufactured in such a way as to ensure the characteristics and performance referred to in Clauses 1 to 8 of the 'General Requirements'. – Use of medical devices must not compromise health and safety. In selecting the most appropriate solutions, product owners should, in the following order of priority: identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse, eliminate risks as far as reasonably practicable through inherently safe design and manufacture, reduce as low as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms, inform users of any residual risks. environmental) conditions and facilities.11.6Packaging systems for non-sterile medical devices should keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system should be suitable taking account of the method of sterilisation indicated by the product owner.11.7The packaging and/or label of the medical device should distinguish between identical or similar products placed on the market in both sterile and non-sterile condition.11.8Medical devices meant by the product owner to be reusable, must be designed and manufactured in a way to facilitate appropriate processes to allow reuse, including cleaning, disinfection, packaging and where appropriate, the method of re-sterilisation.