S.I. No. 109/2009 - European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009

1. The body, its director and the staff responsible for carrying out the evaluation and verification operations shall not be the designer, manufacturer, supplier or installer of devices which they control, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2. The body and its staff must carry out the evaluation and verification operations with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.

3. The body must be able to carry out all the tasks in one of Schedules 2 to 5 assigned to such a body and for which it has been notified, whether those tasks are carried out by the body itself or under its responsibility. In particular, it must have at its disposal the necessary staff and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with evaluation and verification; it must also have access to the equipment necessary for the verifications required.

4. The staff responsible for control operations must have

— sound vocational training covering all the evaluation and verification operations for which the body has been designated,

— satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations,

— the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.

5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls.

6. The body must take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for controls.

7. The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their tasks (except vis--vis the competent administrative authorities of the State in which their activities are carried out) under Directive 90/385/EEC as amended or any provision of national law giving effect to it.

SCHEDULE 9

CE CONFORMITY MARKING

— The CE conformity marking shall consist of the initials ‘CE’ taking the following form

—

— if the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

— the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm. The minimum dimension may be waived for small scale devices.”

GIVEN under the Official Seal of the Minister for Health and Children,

30 March 2009

MARY HARNEY.

Minister for Health and Children.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation)

These regulations amend the European Communities (Active Implantable Medical Devices) Regulations, 1994 (

S.I. No. 253 of 1994

) to give effect to Commission Directive 2007/47/EC of 5 September 2007, which brought in a number of amendments to the earlier Directive with regard to the definitions conformity assessment and general reporting procedures.

1 OJ L 247 21.9.2007 p21

2 OJ L 189 20.7.1990 p.17

3 OJ L 169 12.7.1993 p.1

4 OJ L 311 28.11.2001 p.67. Directive as last amended by Regulation (EC) No. 1901/2006 (OJ L378 27.12.2006, p1)

5 OJ L 390 31.12.2004 p.24

6 OJ L 157 9.6.2006 p.24

8. Devices must be designed and manufactured in such a way as to remove or minimize as far as possible

— the risk of physical injury in connection with their physical, including dimensional, features,

— risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,

— risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,

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

— risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (1)and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure,

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

— excessive increase of leakage currents,

— ageing of the materials used,

— excess heat generated by the device,

— decreased accuracy of any measuring or control mechanism.

9. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I. ‘General requirements’, with particular attention being paid to

— the choice of materials used, particularly as regards toxicity aspects,

— mutual compatibility between the materials used and biological tissues, cells and body fluids, account being taken of the anticipated use of the device,

— compatibility of the devices with the substances they are intended to administer,

— the quality of the connections, particularly in respect of safety,

— the reliability of the source of energy,

— if appropriate, that they are leakproof,

— proper functioning of the programming and control systems, including software.

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.

10. 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 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 device and taking account of 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 the 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 device.

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 to the 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 to the device or not. The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.

11. The devices and, if appropriate, their component parts must be identified to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices and their component parts.

12. Devices must bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and year of manufacture); it must be possible to read this code, 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 operating or adjustment parameters, by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.

14. Every device must bear, legibly and indelibly, the following particulars, where appropriate in the form of generally recognized symbols

14.1. On the sterile pack

— the method of sterilization,

— an indication permitting this packaging to be recognized as such,

— the name and address of the manufacturer,

— a description of the device,

— if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,

— if the device is custom-made, the words ‘custom-made device’,

— a declaration that the implantable device is in a sterile condition,

— the month and year of manufacture,

— an indication of the time limit for implanting a device safely.

14.2. On the sales packaging

— the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,

— a description of the device,

— the purpose of the device,

— the relevant characteristics for its use,

— if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,

— if the device is custom-made, the words: ‘custom-made device’,

— a declaration that the implantable device is in a sterile condition,

— the month and year of manufacture,

— an indication of the time limit for implanting a device safely,

— the conditions for transporting and storing the device,

— in the case of a device within the meaning of Article 1(4a) of Directive 90/385/EEC as amended, an indication that the device contains a human blood derivative.

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

— the year of authorization to affix the CE mark,

— the details referred to in 14.1 and 14.2, with the exception of those referred to in the eighth and ninth indents,

— the performances referred to in section 2 and any undesirable side effects,

— information allowing the physician to select a suitable device and the corresponding software and accessories,

— information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures,

— information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,

— information regarding the risks of reciprocal interference in connection with the presence of the device during specific investigations or treatment,

— the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilization,

— 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.

The instruction leaflet must also include details allowing the physician to brief the patient on the contra-indications and the precautions to be taken.

These details should cover in particular

— information allowing the lifetime of the energy source to be established,

— precautions to be taken should changes occur in the device’s performance,

— 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, etc.,

— adequate information regarding the medicinal products which the device in question is designed to administer,

— date of issue or the latest revision of the instructions for use.

16. Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. ‘General requirements’, in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Schedule 7.

SCHEDULE 2

EC DECLARATION OF CONFORMITY

(Complete quality assurance system)

17. Schedules 1 to 9 of the Principal Regulations (corresponding to Annex I to IX of Directive 90/385/EEC) are deleted and substituted with the following

“SCHEDULE 1

ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

3

rd April

, 2009.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by

section 3

of the

European Communities Act, 1972

, (No. 27 of 1972) and for the purpose of giving full effect to Council Directive 2007/47/EC of 5 September 2007 amending Council Directive 90/385/EEC of 20 July 1990 (

S.I. No. 253 of 1994

) concerning active implantable medical devices, hereby make the following Regulations