The Active Implantable Medical Devices Regulations 1992

Regulation 3(1)

SCHEDULE 2 ESSENTIAL REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES (CORRESPONDING TO ANNEX 1 OF THE DIRECTIVE)

General requirements

1.—(1) The device shall be designed and manufactured in such a way that, when implanted under the conditions and for the purposes laid down by the manufacturer, its use does not compromise the clinical condition or the safety of the patient.

(2) The device shall not present any foreseeable risk to the person implanting it or to other persons.

2.  The device must achieve the performances intended by its manufacturer and, in particular, must be designed and manufactured in such a way that it is suitable for one or more of the following functions as specified by him:—

(a) diagnosis, prevention, monitoring, treatment or alleviation of disease or injury;

(b) investigation, replacement or modification of the anatomy or of a physiological process;

(c) control of conception.

3.  The characteristics and performances referred to in paragraphs 1 and 2 shall not be adversely affected to such a degree that the clinical condition or safety of the patient or of other persons is compromised during the lifetime of the device expected by the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

4.  The device shall be designed, manufactured and packed in such a way that its characteristics and performances are not adversely affected if the conditions as to storage and transport laid down by the manufacturer, such as conditions relating to temperature or humidity, are met.

5.  Any side effects of the device or undesirable conditions resulting from its use shall be reasonably acceptable risks when weighed against the device’s intended performances.

Requirements as to design and construction

6.  In designing and constructing the device the manufacturer shall comply with principles of safety, taking account of the generally acknowledged state of the art at the time of manufacture.

7.  The device shall be designed, manufactured and packed in a non—reusable packaging according to procedures which are sufficient to ensure that—

(a) the device is sterile when placed on the market; and

(b) if handled in accordance with conditions as to storage and transport laid down by the manufacturer, the device remains sterile until the packaging is removed and the device is implanted.

8.  The device shall be designed and manufactured in such a way as to remove or minimise so far as is possible—

(a) the risk of physical injury arising out of its physical features (including its dimensions);

(b) risks connected with the use of sources of energy, including, in the case of a device which uses electricity, risks arising from lack of adequate insulation, from leakage currents and from overheating;

(c) risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure, variations in pressure and acceleration;

(d) risks connected with medical treatment, in particular those resulting from the use of defibrillators or high—frequency surgical equipment;

(e) risks connected with ionising radiation from any radioactive substance included in the device in compliance with the protection requirements laid down in Directive 80/836/Eurotom(1) as amended by Directives 84/467/Euratom(2) and 84/466/Euratom(3);

(f) risks which may arise where maintenance and calibration are impossible, including—

(i) excessive increase of leakage currents,

(ii) ageing of the materials used,

(iii) excess heat generated by the device, and

(iv) decreased accuracy of any measuring or control mechanism.

9.  The device shall be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in paragraphs 1 to 5 with particular attention being paid to—

(a) the choice of materials used, particularly as regards toxicity;

(b) mutual compatibility between the materials used and biological tissues, cells and body fluids (acccount being taken in accordance with regulation 3(2) of the intended use of the device);

(c) compatibility of the device with any substances which it is intended to administer;

(d) the quality of the connections, particularly where considerations of safety are involved;

(e) the reliability of the source of energy;

(f) if appropriate, the need to make it leakproof;

(g) proper functioning of the programming and control systems, including software.

10.  Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC(4), and whose action in combination with the device may result in its bioavailability, the safety, quality and usefulness of the substance, account being taken of the purpose of the device, must be verified by analogy with the appropriate methods specified in Directive 75/318/EEC(5), as last amended by Directive 91/507/EEC(6).

11.  The device and, if appropriate, its component parts must be identifiable to allow any potential risk in connection with the device or any of its component parts.

12.  The device shall bear a code by which it and its manufacturer can be unequivocably identified (particularly with regard to the type of device and year of manufacture) and which can be read, if necessary, without the need for a surgical operation.

13.  When a device or its accessories bear instructions required for the operation of the device or indicate parameters for operating or adjusting it by means of a visual system, such instructions or indications must be understandable to the user and, as appropriate, the patient.

14.—(1) The sterile pack of the device must bear, legibly and indelibly, the following particulars where appropriate in the form of generally recognised symbols—

(a) the method of sterilisation;

(b) an indication that enables the sterile pack to be recognised as such;

(c) the name and address of the manufacturer;

(d) a description of the device;

(e) if the device is intended for clinical investigation, the words: “exclusively for clinical investigations”;

(f) if the device is custom—made, the words “custom—made device”;

(g) a declaration that the device is in a sterile condition;

(h) the month and year of manufacture;

(i) an indication of the time limit for implanting the device safely.

(2) The sales packaging of the device must bear, legibly and indelibly, the following particulars where appropriate in the form of generally recognised symbols—

(a) the name and address of the manufacturer;

(b) a description of the device;

(c) the purpose of the device;

(d) the relevant characteristics for its use;

(e) if the device is intended for clinical investigation, the words: “exclusively for clinical investigation”;

(f) if the device is custom—made, the words “custom—made device”;

(g) a declaration that the device is in a sterile condition;

(h) the month and year of manufacture;

(i) an indication of the time limit for implanting the device safely;

(j) the conditions for transporting and storing the device.

15.—(1) When placed on the market, each device must be accompanied by instructions for use giving the following particulars—

(a) the year of authorisation to affix the EC mark;

(b) the particulars specified in paragraph 14(1)(a) to (g) and (2)(c), (d) and (j);

(c) the performances referred to in paragraph 2 and any undesirable side effects;

(d) information allowing the registered medical practitioner to select a suitable device and the corresponding software and accessories;

(e) information constituting the instructions for use allowing the registered medical practitioner and, where appropriate, the patient to use the device, its accessories and software correctly;

(f) information on the nature of, and scope and times for, operating controls and trials;

(g) where appropriate, information on maintenance measures;

(h) information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided;

(i) information regarding the risk of adverse effects on the device caused by instruments present at the time of specific investigations or treatment, and of adverse effects on instruments present at the time of those investigations or treatment caused by the device;

(j) the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilisation; and

(k) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the essential requirements.

(2) The instructions shall also include details allowing the registered medical practitioner to brief the patient on the contra—indications and the precautions to be taken, including, in particular—

(a) information allowing the lifetime of the energy source to be established;

(b) precautions to be taken should changes occur in the device’s performances;

(c) 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, and similar influences; and

(d) information identifying any medicinal products which the device in question is designed to administer.

(1)

OJ No. L246, 17.9.80, p. 1.

(2)

OJ No. L265, 5.10.84, p. 4.

(3)

OJ No. L265, 5.10.84, p. 1.

(4)

OJ No. 22, 9.2.65, p. 369.

(5)

OJ No. L147, 9.6.75, p. 1.

(6)

OJ No. L270, 26.9.91, p. 32