IE
S.I. No. 110/2009 - European Communities (Medical Devices) (Amendment) Regulations 2009
Table of Provisions (30)
Statutory Text (30 Articles)
1. The notified body, its Director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications. Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of Directive 93/42/EEC as amended and, in particular, of this Schedule.
The notified body shall keep at the disposal of the national authorities the relevant documents assessing the subcontractor’s qualifications and the work carried out by the subcontractor under Directive 93/42/EEC as amended.
3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Schedules 2 to 6 and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. This presupposes the availability of sufficient scientific staff within the organisation who possess experience and knowledge sufficient to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of Directive 93/42/EEC as amended and, in particular, those set out in Schedule 1. It must also have access to the equipment necessary for the verifications required.
4. The notified body must have
— sound vocational training covering all the assessment and verification operations for which the body has been designated,
— satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
— the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.
5. The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.
6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.
7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis--vis the competent administrative authorities of the State in which their activities are carried out) pursuant to Directive 93/42/EEC as amended or any provision of national law putting it into effect.
SCHEDULE 12 CE MARKING OF CONFORMITY
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 (Medical Devices) Regulations, 1994 (
S.I. No. 252 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, p.21
{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 L 378, 27.12.2006, p.1)
(5) OJ L 390, 31.12.2004, p.24
(6) OJ L 157, 9.6.2006, p.24
8. Application to devices in Class IIa In line with Article 11 (2) of Directive 93/42/EEC as amended, this Schedule may apply to products in Class IIa, subject to the following
8.1. in derogation from Sections 1 and 2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Schedule 7 and meet the requirements of Directive 93/42/EEC as amended which apply to them;
8.2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted by the notified body are intended to confirm the conformity of the products in Class IIa with the technical documentation referred to in Section 3 of Schedule 7.
9. Application to devices referred to in Article 1(4a) of Directive 93/42/EEC as amended.
In the case of section 5, upon completing the manufacture of each batch of devices referred to in Article 1(4a) of Directive 93/42/EEC as amended, and in the case of verification under section 6, the manufacturer shall inform the notified body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC
SCHEDULE 5
EC DECLARATION OF CONFORMITY
(Production quality assurance)
10. Devices with a measuring function
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.
10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.
10.3. 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.
11. Protection against radiation
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. Intended radiation
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.
11.2.2. Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such emissions.
11.3. Unintended radiation
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. Instructions
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. Ionizing radiation
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 be varied and controlled taking into account the intended use.
11.5.2. Devices emitting ionizing 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 minimizing radiation exposure of the patient and user.
11.5.3. Devices emitting ionizing 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.
12. Requirements for medical devices connected to or equipped with an energy source
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.
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.
12.2. 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.
12.3. Devices where the safety of the patients depends on an external power supply must include an alarm system to signal any power failure.
12.4. 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 patient’s state of health.
12.5. Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment.
12.6. 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.
12.7. Protection against mechanical and thermal risks.
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.
12.7.2. 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 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.
12.7.4. 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 minimize all possible risks.
12.7.5. 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.
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.
12.8.2. 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.
12.9. 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 appropriate, the patient.
13. Information supplied by the manufacturer
13.1. 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.
13.2. 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.
13.3. 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’;
(
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 sterilization;
(
n
) in the case of a device within the meaning of Article 1(4a) of Directive 93/42/EEC as amended, 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.
13.5. 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.
13.6. 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 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 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.
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 re-used. 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, 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, 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.
SCHEDULE 2
EC DECLARATION OF CONFORMITY
(Full quality assurance system)
14. Regulation 3 (Application) of the Principal Regulations is amended by adding after Paragraph (6) a new Paragraph (7) with the following words
“(7) These Regulations shall not affect the application of the
Radiological Protection Act 1991
Ionising Radiation order (
S.I. No. 125 of 2000
) and European Communities (Medical Ionising Radiation Protection) Regulations (
S.I. No. 478 of 2002
) as amended.”
15. Regulation 4 (Classification) of the Principal Regulations is amended by deleting Paragraph (3) and substituting the following words
“(3) Where the Minister considers that—
(a) the application of the classification rules set out in Schedule 9 requires a decision with regard to the classification of a given device or category of devices; or
(b) a given device or family of devices should be classified by way of derogation from the provisions of Schedule 9 in another class; or
(c) the conformity of a device or family of devices should be established by way of derogation from the provisions of article 7,8, 9 or 10 of Directive 93/42/EEC as amended, by applying solely one of the given procedures chosen from among those referred to in that article; or
(d) a decision is required as to whether a particular product or product group falls within one of the definitions in Regulation 2 (Definitions);
and where the Minister considers that the classification rules set out in Schedule 9 require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Regulation 20, the Minister, may submit a duly substantiated request to the Commission of the European Union and ask it to take the necessary measures for adaptation of the classification rules.”
16. Regulation 5 (Essential Requirements) of the Principal Regulations is amended by deleting Paragraph 7 and substituting the following
“(7) The manufacturer of a custom-made device shall follow the procedure set out in Regulation 5 of the Principal Regulations and Schedule 8; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Schedule 8 which shall be available to the particular patient identified by name, an acronym or a numerical code and the manufacturer should ensure that the statement is supplied with the custom-made device so that it may be made available to the patient on request.”
17. Regulation 5 (Essential Requirements for devices) of the Principal Regulations is amended by adding after Paragraph (8) a new Paragraph (9)
“(9) Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Schedule 1 of these Regulations.”
18. The title of Regulation 11 of the Principal Regulations is amended by deleting the words
“Procedure for systems and procedure packs”
and substituting the words
“Particular procedure for systems and procedure packs and procedure for sterilisation”
19. Paragraph 3(a) of Regulation 11 of the Principal Regulations is deleted and the following paragraph substituted
“(a) Choose to follow one of the procedures referred to in Schedule 2 or 5, the application of which is limited to the aspects of the procedure relating to the obtaining of sterility, until the sterile package is opened or damaged.”
20. Paragraph (6) of Regulation 11 of the Principal Regulations is amended by deleting the words
“The declaration referred to in subarticles (1) and (3)(b) shall be kept available for the Minister or an authorised officer for a period of five years.”
and substituting the words
“The declarations referred to in paragraphs (1) and (3)(b) shall be kept at the disposal of the Competent Authority for a period of five years.”;
21. Paragraph 6 of Regulation 12 (General Provisions relating to conformity assessment procedures) of the Principal Regulations is amended by deleting the words
“A decision made by a notified body in accordance with Schedule 2 or Schedule 3 shall—”
and substituting the following words
“A decision made by a notified body in accordance with Schedules 2, 3, 5 and 6 shall—”
22. Paragraph 8 of Regulation 12 (General Provisions relating to conformity assessment procedures) of the Principal Regulations is amended by deleting the words
“Where a period of validity has been extended under subarticle (7), the notified body may, on application made by the manufacturer, grant a further extension of 5 years.”
and substituting the following words
“Where a period of validity has been extended under paragraph (7), the notified body may, on application made by the manufacturer, grant an extension for further periods of a maximum length of 5 years.”
23. Regulation 14 (Registration of persons placing devices on the market) of the Principal Regulations is amended by deleting paragraphs 3, 3(a), 3(b) and 3(c) and inserting the following
“(3) A manufacturer who places a device on the market under his or her own name but does not have a registered place of business in the state or another member state of the European Union, shall designate a single authorised representative in the state or another member state of the European Union.”
24. Regulation 14 (Registration of persons placing devices on the market) of the Principal Regulations is amended by adding a new paragraph 4 as follows
“(4) A person in the State who has been designated as an authorised representative by a manufacturer who does not have a registered place of business in the Community to place on the market a device referred to in subarticle (1) shall inform the Competent Authority of
(a) his or her registered place of business;
(b) the type of device; and
(c) shall furnish the Competent Authority with sufficient evidence that he or she is the authorised representative of the manufacturer.”
25. Regulation 14A of the Principal Regulations is amended by deleting all the words including the title and substituting the following:“Information relating to Class IIa, IIb and III devices
(14A) The manufacturer or the authorised representative of the manufacturer may supply to the Competent Authority for all medical devices of Class IIa IIb and III data allowing for the identification of such devices together with the label and the instructions for use when such devices are put into service in the State.”
26. Regulation 16 (Clinical investigations) of the Principal Regulations is amended by deleting all the paragraphs and substituting the following paragraphs
“(1) In the case of devices intended for clinical investigations to be conducted in Ireland, the manufacturer or the authorised representative shall follow the procedure referred to in Schedule 8 to these regulations and notify the Competent Authority by means of the statement mentioned in Section 2 of Schedule 8 to these regulations.
(2) In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the Competent Authority have notified the manufacturer within that period of a decision to the contrary based on considerations of public health or public policy.
However manufacturers may be authorised by the Competent Authority to commence the relevant clinical investigations before the expiry of the period of 60 days, in so far as the Ethics Committee has issued a favourable opinion on the programme of investigation, including its review of the clinical investigation plan.
(3) In the case of devices other than those referred to in paragraph 2 of this regulation, manufacturers may be authorised by the Competent Authority to commence clinical investigations immediately after the date of notification, provided that the Ethics Committee mentioned above has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.
(4) Clinical investigations shall be conducted in accordance with the provision of Schedule 10 to these regulations.
(5) Where a clinical investigation is refused or halted, the Competent Authority shall communicate such decision and the grounds thereof to all Member States and the Commission. Where a significant modification or temporary interruption of a clinical investigation has been called, the Competent Authority shall inform the Member States concerned about such actions and the grounds for the actions taken.
(6) The manufacturer or his or her authorised representative shall notify the Competent Authority and the competent authorities of the other Member States concerned of the end of the clinical investigation, with a justification in case of early termination.
(a) In the case of early termination of the clinical investigation on safety grounds, the notification referred to in regulation 16(6) above shall be communicated by the Competent Authority to all Member States and the Commission.
(b) The manufacturer or the authorised representative of the manufacturer shall keep the report referred to in Section 2.3.7 of Schedule 10 to these regulations at the disposal of the Competent Authority and the competent authorities of the other Member States concerned.
(7) The provisions of Regulations 16(1) and 16(2) above do not apply where the clinical investigations are conducted using devices which are authorised in accordance with Regulations 12(1) to (11) of these regulations to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. The relevant provisions of Schedule 10 to these regulations remain applicable.”
27. Regulation 17 (Notified Bodies) of the Principal Regulations is amended by deleting paragraphs 3, 3(a) and 3(b) and substituting the following
“(3) The Notified Body shall inform the Competent Authority about all CE Marking approvals issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of the Directive about CE Marking approvals suspended, withdrawn or refused and, on request, about CE Marking approvals issued. The notified body shall also make available, on request, all additional relevant information.”
28. Regulation 26 (Offences) of the Principal Regulations is amended by deleting paragraph 5 and substituting the following words
“(5) Proceedings for an offence under these Regulations may be instituted at any time within two years from the date on which the offence was committed.”
29. Schedules 1 to 12 of the Principal Regulations amended by Statutory Instrument 444 of 2001 (corresponding to Annex I to XII of Directive 93/42/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 93/42/EEC of 14 June 1993 (
S.I. No. 252 of 1994
) concerning medical devices, hereby make the following Regulations