A/NA

Evidence of Compliance and Location;  Other Remarks

- 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.

7.1. 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.

8.1. 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.

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 he carried out so as to provide optimal security. In particular safety with regard to viruses and other transferable agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.

9.1. 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.

- 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.

10.1. 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.

11.1. General

11.1.1. 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.

11.2.1. 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.

11.3.1. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible.

11.4.1. 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.

11.5.1. Devices intended to emit ionizing 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 he varied and controlled taking into account the intended use.

12.1. 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 to eliminate or reduce as far as possible consequent 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.

12.7.1. 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.

12.8. Protection against the risks posed to the patient by energy supplies or substances

12.8.1. 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 incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

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 appropriate, the patient.

13.1. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users.

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 our 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 our 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.

(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 either the person responsible referred to in Article 14 (2) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;

(b) the details strictly necessary for the user to identify the device and the contents of the packaging;

(c) where appropriate, the word 'STERILE';

(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;

(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 (c). This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization.

(a) the details referred to in Section 13.3, with the exception of (d) and (c;

(b) the performances referred to in Section 3 and any undesirable side-effects;

(c) if the device must he 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 resterilization;

(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 resterilized, 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;

(i) details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes, 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 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.

14. Where conformity with the essential requirements must be based on clinical data, as in Section I (6), such data must be established in accordance with Annex X.