93-42-EC ER Checklist Example

Medical Devices Directive Compliance Essential Requirements Checklist
Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
I. 1. 2. 1.
General Requirements The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, 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 any risks which may be associated with their intended 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. This shall include: reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: eliminate or reduce risks as far as possible (inherently safe design and construction), where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, inform users of the residual risks due to any shortcomings of the protection measures adopted. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in
Template reference: 123
Applicable or N/A A
Compliance Details/Assessment Certified by Notified Body to ISO 9001:2008 & ISO 13485:2012. Compliance to BS EN ISO 8185:2009. Well established product range.
References ISO 9001 & 13485 Certs. Technical File
Ergonomic features part of design considerations.
Complaint analysis
Simple design concept.
2.
Complies with BS EN ISO 8185:2009.
Technical File
From complaints history review no risk identified. Inherently safe and simple design.
Instructions for use
Safety/operating instruction leaflet. A Compliance to BS EN ISO 8185:2009. Designed to ISO 9001:2008 & ISO 13485:2012 Quality Systems. Company Standard Operating Procedures (SOP file). Technical File
3.
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Article 1 (2) (a), as specified by the manufacturer. 4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients 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. The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer. Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended. A Compliance to BS EN ISO 8185:2009. From complaints history review no risk identified. Technical File
5.
Compliance to BS EN ISO 8185:2009. Works Instructions: All products separately identified Well Established Product. From Complaints History Review: No New Risk Identified. Well Established Product. From Complaints History Review: No New Risk Identified.
Tech. File Work Instructions Technical File
6.
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 6a. Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. A Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X.
Bubble Humidifiers are fairly simple devices to be used in conjunction with medical gas delivery, as the name implies they are intended to humidify the gas supplied to a patient. They consist of an inlet port that is connected to a tube and diffuser. The diffuser sits in a reservoir of water inside the bottle and this breaks the gas into small bubbles. The humidified gas then flows out of the outlet to the patient. The ACME device follows this basic design. Design, performance, intended use and safety aspects of devices equivalent to the ACME device are outlined in the literature referenced below. It is known that these devices are not very efficient in terms of humidity 1 output and are primarily intended to use with Oxygen . However they can 2 adequately condition medical gases . It is acknowledged that there are numerous models and manufacturers of such devices e.g. Ohmeda, and 4 their instructions for safe use is fairly generic . There have been a number of alerts with such devices in the USA, these have related to leakage e.g. due 5,6 to missing parts . There has been one recent UK recall for a similar device 7 that had a faulty part (not present on ACME device). 1. Basic Lab Competencies for Respiratory Care; Gary C White; Thomson Delmar Learning; 2002; page 262. 2. Intensive Care Medicine: Annual Update 2003; Jean-Louis Vincent; page 258. 3. Working in the Operating Department; Bakul Kumar; Elservier Health Sciences; 1998; page 158. 4. Equipment Theory for Respiratory Care; Gary C White; Thomson Delmar Learning; 1998. 5. FDA Catalogue Number 006-01; 10/04/1996; Hudson RCI Bubble Humidifier. 6. FDA Catalogue Number 2D0803; 10/08/2002; Alligiance Pre-filled Bubble Humidifier. 7. MDA/2007/061; Hudson RCI large volume nebuliser; 13 August 2007 The device has been designed using design input from existing products that have been supplied by ACME acting as agents for approximately 20 years. There have never been any complaints or adverse events associated with this current or previously supplied devices. As such there is no recorded further clinical data specific to the ACME device, except re-order data.
Medical Device Literature File Technical File Also further references at end of BS EN ISO 8185:2009 (pages 48 & 49)
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 II. 7. 7.1 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
Requirements Regarding Design & Construction Chemical, physical and biological properties. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the General requirements. Particular attention must be paid to: the choice of materials used, particularly as regards toxicity and, where appropriate, flammability, the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device, where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand. The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure. The devices must 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 normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy
Physical construction compliance to BS EN ISO 8185:2009. Well Established Product. From Complaints History Review & Risk Management - No New Risk Identified. Food grade materials used. Not an intended used.
Tech. file
No such studies conducted or required. A Compliance to BS EN ISO 8185:2009. From Complaints History Review: No New Risk Identified. Handling, Packing, Storage, Preservation & Delivery Tech. File
7.2
SOP 6
7.3
BS EN ISO 14971:2009 - Risk Management Well Established Product. From Complaints History Review: No New Risk Identified
Tech. file
7.4
N/A
No medicinal products incorporated.
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with the methods specified in Annex I to Directive 2001/83/EC. For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 [*] on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body. Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained. The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.
N/A
No medicines in the product.
N/A
No blood derivatives incorporated.
N/A
No ancillary substances.
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. N/A No ancillary substances Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance in the medical device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure. 7.5 The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device. Special attention shall be given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids or other substances to or from the body, or devices intended for transport and storage of such body fluids or substances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as a device containing phthalates. If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women, the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements, in particular of this paragraph, within the technical documentation and, within the instructions for use, information on residual risks for these patient groups and, if applicable, on appropriate precautionary measures.
Compliance to BS EN ISO 8185:2009. Product Performance designed not to leak. No risk identified.
Tech. file
N/A
No phthalates in materials.
N/A
No phthalates in materials.
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 7.6 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. A Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
Devices must be designed and manufactured in such a way as to reduce, as much as possible, risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used. Infection and microbial contamination. The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use. Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. Notified bodies shall retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses and other transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process. Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile, under the storage and transport conditions laid down, until the protective packaging is damaged or opened. Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate, validated method. Devices intended to be sterilized must be manufactured in appropriately controlled (e. g. environmental) conditions.
Compliance to BS EN ISO 8185:2009. Well established Product. Complaints History Review & Risk Management No New Risks Identified.
Tech. file Complaints record
8. 8.1
All parts of the Humidifier Assembly may be steamed/autoclaved cleaned to a temperature of 121C for a cycle not greater than 8 minutes. This is detailed in the Safety & Operating Instructions.
Technical File Instructions for use
8.2
N/A
No tissues of animal origin.
8.3
N/A
Not a sterile product.
8.4 8.5
N/A N/A
Not a sterile product. All parts of the Humidifier Assembly may be steamed/autoclaved, but this is not necessarily intended. Instructions for use
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 8.6 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. A Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
Packaging systems for non-sterile devices must keep the product without deterioration at the level of cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of microbial contamination; the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer. The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition. Construction and environmental properties. If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices. Any restrictions on use must be indicated on the label or in the instructions for use. Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible: the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features, risks connected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature or variations in pressure and acceleration, the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given, risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism. Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to
Procedure - Handling, Packing, Storage, Preservation & Delivery
SOP 6
8.7
N/A
Not a sterile product.
9. 9.1
The Humidifier has been designed to be used with other devices (e.g. Flowmeters) and this does not affect the quality and performance of the product. It has been designed in accordance with BS EN ISO 8185:2009.
Technical File
9.2
Technical File A Construction complies with BS EN ISO 8185:2009 and it is designed to withstand 2.5 times the normal medical gas pressure (4 bar). See Risk Analysis. Risk Management
A N/A
A flowmeter can be attached, but this adds no risk, in fact can aid use. No measuring function other liquid level scale.
9.3
The Humidifier has been designed to minimise the risk of ignition/explosion when used with Oxygen. No risk identified.
Technical File
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substances which could cause combustion. 10. 10.1 Devices with a measuring function. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (1). Protection against radiation. General. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes. Intended radiation. Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters. Where devices are intended to emit potentially hazardous, visible N/A No radiation emitted. N/A No radiation emitted. N/A No direct measuring function.
10.2
N/A
No direct measuring function.
10.3
N/A
No direct measuring function.
11. 11.1 11.1.1
11.2 11.2.1
11.2.2
N/A
No radiation emitted.
1 OJ No L 39, 15, 2, 1980, p.40. Directive as last amended by Directive 89/617/EEC (OJ No L 357,7,12,1989, p.28)
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and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions. 11.3 11.3.1 Unintended radiation Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emissions of unintended, stray or scattered radiation is reduced as far as possible. Instructions The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation. Ionising radiation Devices intended to emit ionising radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can be varied and controlled taking into account the intended use. Devices emitting ionising radiation intended for diagnostic radiology shall 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. Devices emitting ionising radiation intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and energy and where appropriate the quality of radiation. Requirements for medical devices connected to or equipped with an energy source. Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a single fault, condition (in the system) appropriate means should be adopted N/A Not electronic. N/A No radiation emitted. N/A No radiation emitted. N/A No radiation emitted.
11.4 11.4.1
11.5 11.5.1
11.5.2
N/A
11.5.3
N/A
12. 12.1
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to eliminate or reduce as far as possible consequent risks. 12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification. Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure. Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patients state of health. Devices must be designed and manufactured in such a way as to minimise the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment. Protection against electrical risks. Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided the devices are installed correctly. Protection against mechanical and thermal risks. Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts. Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of A Safety characteristics comply with BS EN ISO 8185:2009. Technical File N/A Not electronic.
12.2
N/A
Not electronic.
12.3
N/A
Not powered.
12.4
N/A
No monitoring function.
12.5
N/A
Not electronic.
12.6
N/A
Not electronic.
12.7 12.7.1
12.7.2
N/A
No vibration generated.
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the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. 12.7.3 Devices must be designed and manufactured in such a way as to reduce to the lowest possible level 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. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user has to handle must be designed and constructed in such a way as to minimise all possible risks. Accessible parts of the devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal use. Protection against the risks posed to the patient by energy supplies or substances. Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user. Devices must be fitted with the means of preventing and/or indicating any inadequacies in the flow-rate which could pose a danger. Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source. The function of the controls and indicators must be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as A The flow rate through the device is intended to regulated by a Flowmeter which should conform to BS EN ISO 15002:2008. Technical File Instructions for use Technical File N/A No noise generated.
12.7.4
Complies with BS EN ISO 8185:2009. No risk identified/
Technical File
12.7.5
N/A
Cannot generate heat.
12.8 12.8.1
12.8.2
A A
Complies with BS EN ISO 8185:2009. Complies with BS EN ISO 8185:2009.
12.9
A A
Complies with BS EN ISO 8185:2009. Fluid level indicator marked on product.
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 appropriate, the patient. 13. 13.1 Information supplied by the manufacturer. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer. This information comprises the details on the label and the data in the instructions for use. As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices. Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device. The label must bear the following particulars: (a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community; (b) the details strictly necessary to identify the device and the contents of the packaging especially for the users; (c) where appropriate, the word STERILE;
Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data.
Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10
Date: 22.10.12
Operation & Safety Instructions comply with BS EN ISO 8185:2009 (see BS EN 1041:2008 for IFU guidance). Product is identified by means of labelling. Operation & Safety Instruction leaflet.
Technical File
A A
Technical File / Operating Instructions
Product is Class IIa device. Operation & Safety Instructions and supply information in accordance with BS EN ISO 8185:2009. Note: the product is very simple and can be safely used without instructions. Markings used comply with BS EN ISO 8185:2009 and symbols used in IFU and labelling with BS EN ISO 15223-1. Technical File
13.2
13.3
The Humidifier instructions for use and the packaging label carry the name and address of the company (manufactured in EC).
Technical File / labels
A N/A
Identified by device product code. Not Sterile.
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Product: Bubble Humidifier Standard used for compliance: Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 Product/Product Group: ABC Series Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. A N/A N/A Completed by: J Bloggs Product Status: (New or Well Established): Well Established product Released 22.10.10 Date: 22.10.12
(d) where appropriate, the batch code, preceded by the word LOT, or the serial number; (e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month; (f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community; (g) if the device is custom-made, the words custom-made device; (h) if the device is intended for clinical investigations, the words exclusively for clinical investigations; (i) any special storage and/or handling conditions; (j) any special operating instructions; (k) any warnings and/or precautions to take; (l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number; (m) where applicable, method of sterilisation; (n) in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative. 13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must clearly state it on the label and in the instructions for use. Wherever reasonable and practicable, the devices and detachable components must be identified, where appropriate in terms of batches, to allow all appropriate action to detect any potential risk posed by the devices and detachable components. Where appropriate, the instructions for use must contain the following particulars: (a) the details referred to in Section 13.3, with the exception of (d) and (e); (b) the performances referred to in Section 3 and any undesirable
Each Humidifier is uniquely identified with Serial or Lot number. However, each Humidifier packaging label carries the year and month of manufacture. Not single use.
N/A N/A N/A N/A A A A N/A A
Not custom made. Not intended for clinical investigations. None required. No special instructions. Precautions to take and safety instructions are on the leaflet. Each Humidifier carries the year and month of manufacture on packaging. Instructions for use indicate that the product can be autoclaved. No blood derivatives incorporated. Intended use should be clear, but instruction are on leaflet. Operating Instructions Label Operating Instructions
Operating Instructions SOP File
13.5
Component batches are recorded on the devices Product Kit List which is applied throughout the quality system (ISO 13485:2012/ISO 9001:2008). Controlled by SOP18 Production Identification & Traceability. .
13.6
A A
Complies with BS EN ISO 8185:2009. Complies with BS EN ISO 8185:2009.
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side-effects; (c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination; (d) all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times; (e) where appropriate, information to avoid certain risks in connection with implantation of the device; (f) information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment; (g) the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of re-sterilisation; (h) if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be resterilised, and any restriction on the number of reuses. Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be such that, if correctly followed, the device will still comply with the requirements in Section I; If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be reused. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request; (i) details of any further treatment or handling needed before the device can be used (for example, sterilisation, final assembly, etc.); (j) in the case of devices emitting radiation for medical purposes,
Detailed in Safety & Operating Instructions.
Detailed in Safety & Operating Instructions.
N/A N/A N/A
Not implantable. Not for specific investigations. Not sterile.
The product is reusable after cleaning/disinfecting. Process instructions to allow reuse are defined in the Safety & Operating Instructions.
N/A N/A
No further treatment required. No radiation emitted.
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details of the nature, type, intensity and distribution of this radiation. The instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular: (k) precautions to be taken in the event of changes in the performance of the device; (l) precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.; (m) adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered; (n) precautions to be taken against any special, unusual risks related to the disposal of the device; (o) medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4; (p) degree of accuracy claimed for devices with a measuring function; (q) date of issue or the latest revision of the instructions for use.
A N/A
Details in Operating Instructions. No exposure issues.
Intended to supply humidified air/oxygen details in Operating Instructions.
N/A N/A N/A A
No unusual risks. No medical/blood products. No direct measuring function. Given on Safety & Operating Instruction leaflet.
Based on the above evaluation and the supporting documentation the undersigned confirms that all applicable essential requirements are fulfilled.
Name:
J Bloggs
Signature:
J Bloggs
Position:
Quality Manager
16 of 16

93-42-EC ER Checklist Example

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Medical Devices Directive Compliance Essential Requirements Checklist

References ISO 9001 & 13485 Certs. Technical File

Ergonomic features part of design considerations.

Simple design concept.

Complies with BS EN ISO 8185:2009.

Instructions for use

Medical Devices Directive Compliance Essential Requirements Checklist

Tech. File Work Instructions Technical File

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

No medicinal products incorporated.

Medical Devices Directive Compliance Essential Requirements Checklist

No medicines in the product.

No blood derivatives incorporated.

Medical Devices Directive Compliance Essential Requirements Checklist

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Tech. file Complaints record

Technical File Instructions for use

No tissues of animal origin.

Not a sterile product.

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Procedure - Handling, Packing, Storage, Preservation & Delivery

Not a sterile product.

Medical Devices Directive Compliance Essential Requirements Checklist

No direct measuring function.

No direct measuring function.

11. 11.1 11.1.1

Medical Devices Directive Compliance Essential Requirements Checklist

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Complies with BS EN ISO 8185:2009. No risk identified/

Cannot generate heat.

Complies with BS EN ISO 8185:2009. Complies with BS EN ISO 8185:2009.

Complies with BS EN ISO 8185:2009. Fluid level indicator marked on product.

Technical File Instructions for use

Template reference: 123

Medical Devices Directive Compliance Essential Requirements Checklist

Technical File / Operating Instructions

Technical File / labels

Identified by device product code. Not Sterile.

Medical Devices Directive Compliance Essential Requirements Checklist

N/A N/A N/A N/A A A A N/A A

Operating Instructions SOP File

Complies with BS EN ISO 8185:2009. Complies with BS EN ISO 8185:2009.

Technical File Instructions for use

Medical Devices Directive Compliance Essential Requirements Checklist

Detailed in Safety & Operating Instructions.

Detailed in Safety & Operating Instructions.

N/A N/A N/A

Not implantable. Not for specific investigations. Not sterile.

No further treatment required. No radiation emitted.

Medical Devices Directive Compliance Essential Requirements Checklist

Details in Operating Instructions. No exposure issues.

Intended to supply humidified air/oxygen details in Operating Instructions.