DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998 on in vitro diagnostic medical devices

Posted on January 26, 2012. Filed under: Uncategorized |

1. This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as in vitro diagnostic medical devices in their own right. Both in vitro diagnostic medical devices and accessories shall hereinafter be termed devices.

2. For the purposes of this Directive, the following definitions shall apply:

(a) ‘medical device` means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

(b) ‘in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
– concerning a physiological or pathological state, or
– concerning a congenital abnormality, or
– to determine the safety and compatibility with potential recipients, or
– to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles` are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(c) ‘accessory` means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;

(d) ‘device for self-testing` means any device intended by the manufacturer to be able to be used by lay persons in a home environment;

(e) ‘device for performance evaluation` means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside his own premises;

(f) ‘manufacturer` means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as devices with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

(g) ‘authorised representative` means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;

(h) ‘intended purpose` means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials;

(i) ‘placing on the market` means the first making available in return for payment or free of charge of a device other than a device intended for performance evaluation with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(j) ‘putting into service` means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose.

3. For the purposes of this Directive, calibration and control materials refer to any substance, material or article intended by their manufacturer either to establish measurement relationships or to verify the performance characteristics of a device in conjunction with the intended use of that device.

4. For the purposes of this Directive, the removal, collection and use of tissues, cells and substances of human origin shall be governed, in relation to ethics, by the principles laid down in the Convention of the Council of Europe for the protection of human rights and dignity of the human being with regard to the application of biology and medicine and by any Member States regulations on this matter.

5. This Directive shall not apply to devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity. This does not affect the right of Member State to subject such activities to appropriate protection requirements.

6. This Directive shall not affect national laws which provide for the supply of devices by a medical prescription.

7. This Directive is a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC, which shall cease to apply to devices which have complied with this Directive.

Article 2 Placing on the market and putting into service


Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation.

Article 3 Essential requirements


Devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.

Article 4 Free movement


Article 5 Reference to standards


Article 6 Committee on Standards and Technical Regulations 

Article 7 Committee on Medical Devices 

Article 8 Safeguard clause 

Article 9 Conformity assessment procedures 

Article 10 Registration of manufacturers and devices 

Article 11 Vigilance procedure 

1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:

(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health;

(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.

2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.

3. After carrying out an assessment, if possible together with the manufacturer, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.

4. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a ‘new` product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market.

5. The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the procedure referred to in Article 7(2).

Article 12 European databank 

1. Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

(a) data relating to registration of manufacturers and devices in accordance with Article 10;

(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedure as laid down in Annexes III to VII;

(c) data obtained in accordance with the vigilance procedure as defined in Article 11.

2. Data shall be forwarded in a standardised format.

3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2).

Article 13 Particular health monitoring measures 

Article 14 Amendments to Annex II, and derogation clause 
Article 15 Notified bodies 

Article 16 CE marking 

Article 17 Wrongly affixed CE marking 

Article 18 Decisions in respect of refusal or restriction 

Article 19 Confidentiality 

Article 20 Cooperation between Member States 

Article 21 Amendment of directives 

1. In Directive 89/392/EEC, the second indent of Article 1(3), ‘machinery for medical use, used in direct contact with patients` shall be replaced by the following:

‘- medical devices,`.

2. Directive 93/42/EEC is hereby amended as follows:

(a) in Article 1(2):
– point (c) shall be replaced by the following:

‘(c) “in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

– concerning a physiological or pathological state, or
– concerning a congenital abnormality, or
– to determine the safety and compatibility with potential recipients, or
– to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. “Specimen receptacles” are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;`

– point (i) shall be replaced by the following:
‘(i) “putting into service” means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;`
– the following point shall be added:

‘(j) “authorised representative” means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;`

(b) Article 2 shall be replaced by the following:

‘Article 2
Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.`
(c) the following paragraph shall be added to Article 14(1):
‘For all medical devices of classes IIb and III, Member States may request to be informed of all data allowing for identification of such devices together with the label and the instructions for use when such devices are put into service within their territory.`

(d) the following Articles shall be inserted:

‘Article 14a

European databank
1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.
The databank shall contain the following:

(a) data relating to registration of manufacturers and devices in accordance with Article 14;

(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;

(c) data obtained in accordance with the vigilance procedure as defined in Article 10;

2. Data shall be forwarded in a standardised format.

3. The procedures implementing this Article shall be adopted in accordance with the procedure laid down in Article 7(2).

Article 14b

Particular health monitoring measures

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States giving the reasons for its decision. The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2).`

(e) the following paragraphs shall be added to Article 16:

‘5. The notified body shall inform the other notified bodies and the competent authority about all certificates suspended or withdrawn and, on request, about certificates issued or refused. It shall also make available, on request, all additional relevant information.

6. Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof. The Member State shall inform the other Member States and the Commission.

7. The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Member State to verify compliance with Annex XI requirements.`

(f) the following paragraph shall be added to Article 18:

‘Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.`
(g) in Article 22(4), the first subparagraph shall be replaced by the following:

‘4. Member States shall accept:

– devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and

– the aforementioned devices being put into service until 30 June 2001 at the latest.`

(h) Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2 shall be deleted;

(i) in Annex XI, section 3 the following sentence shall be inserted after the second sentence:
‘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 this Directive and, in particular, those set out in Annex I. 

Article 22 Implementation, transitional provisions 

Article 23 

Article 24 

ANNEX I
ESSENTIAL REQUIREMENTS

A. GENERAL REQUIREMENTS 

B. DESIGN AND MANUFACTURING REQUIREMENTS 



ANNEX II
LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) AND (3)
List A 
– Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
– reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.


List B 
– Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd,


– reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies,

– reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis,
– reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,

– reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia,

– reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,

– reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,

– reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,

– the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar. 

ANNEX III
EC DECLARATION OF CONFORMITY

ANNEX IV
EC DECLARATION OF CONFORMITY (FULL QUALITY ASSURANCE SYSTEM)

ANNEX V
EC TYPE-EXAMINATION

ANNEX VI
EC VERIFICATION


ANNEX VII
EC DECLARATION OF CONFORMITY (PRODUCTION QUALITY ASSURANCE)

ANNEX VIII
STATEMENT AND PROCEDURES CONCERNING DEVICES FOR PERFORMANCE EVALUATION

ANNEX IX
CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES

ANNEX X
CE MARKING OF CONFORMITY

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