A4-0031/96

Proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices (COM(95)0130 - C4-0152/95 - 95/0013(COD))

The proposal was approved with the following amendments:

(Amendment 1)

Recital 3

>Original text>

Whereas the harmonization of national legislations is the only means of removing these barriers to free trade and preventing new barriers; whereas this objective cannot be achieved in a satisfactory manner at another level by the individual Member States; whereas this Directive only lays down necessary and sufficient requirements for the free circulation of the in vitro diagnostic medical devices to which it is applicable;

>Text following EP vote>

Whereas the harmonization of national legislations is the means of removing these barriers to free trade and preventing new barriers; whereas this objective cannot be achieved in a satisfactory manner at another level by the individual Member States; whereas this Directive only lays down necessary and sufficient requirements for the free circulation, in the best possible safety conditions of the in vitro diagnostic medical devices to which it is applicable;

(Amendment 2)

Recital 5

>Original text>

Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive;

>Text following EP vote>

Whereas in vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection and attain the performance levels originally attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of health protection attained in the Member States is one of the essential objectives of this Directive;

(Amendment 3)

Recital 6

>Original text>

Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design and manufacture of relevant products must be confined to the provisions required to meet the essential requirements; whereas because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimize and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety.

>Text following EP vote>

Whereas, in accordance with the principles set out in the Council resolution of 7 May 1985 concerning a new approach to technical harmonization and standardization, rules regarding the design manufacture and packaging of relevant products must be confined to the provisions required to meet the essential requirements; whereas because they are essential, such requirements should replace the corresponding national provisions; whereas the essential requirements, including requirements to minimize and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety.

(Amendment 4)

Recital 9a (new)

>Text following EP vote>

Whereas mechanical laboratory equipment especially designed for in vitro diagnostic examinations falls within the scope of this Directive; whereas, therefore, in order to harmonize the relevant Directives, Directive 89/392/EEC1 as last amended by Directive 93/68/EEC2 should be appropriately amended to bring it into line with this Directive.

1 OJ L 183, 29.6.1989, p. 9.

2 OJ L 220, 30.8.1993, p. 1.

(Amendment 5)

Recital 15

>Original text>

Whereas the list of in vitro diagnostic medical devices to be subjected to third party conformity assessment needs updating, taking account of technological progress and of evolution in the domain of protection of health; whereas such updating measures must be taken in line with the procedure IIIa as laid down in Council Decision 87/373/EEC; whereas a system of adverse incident reporting (vigilance) constitutes a useful tool for the surveillance of the market, including the performance of new devices; whereas information obtained from vigilance as well as from external quality assessment schemes becomes useful for decision-making on classification of devices.

>Text following EP vote>

Whereas the list of in vitro diagnostic medical devices to be subjected to third party conformity assessment needs updating, taking account of technological progress and of evolution in the domain of protection of health; whereas such updating measures must be taken in line with the procedure IIIa as laid down in Council Decision 87/373/EEC; whereas a system of adverse incident reporting (vigilance) constitutes a useful tool for the surveillance of the market, the performance of new devices being included; whereas information obtained from vigilance as well as from external quality assessment schemes becomes useful for decision-making on classification of devices.

(Amendment 6)

Recital 18

>Original text>

Whereas the competent authorities in charge of market surveillance must be able, particularly in emergencies, to contact the manufacturer or his authorized representative established in the Community; whereas cooperation and exchange of information between Member States are necessary in view of uniform application of this Directive, in particular for the purpose of market surveillance

>Text following EP vote>

Whereas the competent authorities in charge of market surveillance must be able, particularly in emergencies, to contact the manufacturer or his authorized representative established in the Community, in order to take any protection measures that should prove necessary; whereas cooperation and exchange of information between Member States are necessary in view of uniform application of this Directive, in particular for the purpose of market surveillance.

(Amendment 7)

Recital 19

>Original text>

Whereas this Directive includes in vitro diagnostic medical devices incorporating substances derived from the human body, it does not affect national regulations relating to the ethics of use of such substances; whereas for the purpose of overall consistency between medical devices directives, Directive 93/42/EEC needs to be amended accordingly;

>Text following EP vote>

Deleted

(Amendment 8)

ARTICLE 1(1)

>Original text>

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.

>Text following EP vote>

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

(Amendment 10)

ARTICLE 1(2)(b), 1st subparagraph

>Original text>

(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 state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients. For the purpose of this Directive, a specimen receptacle, whether evacuated or not, specifically intended by its manufacturer to contain a specimen for the purpose of in vitro diagnostic examination is considered to be a device.

>Text following EP vote>

(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 state, pathological state or congenital abnormality or to determine the safety and compatibility with potential recipients. For the purpose of this Directive, a specimen receptacle, whether a vacuum-type or not, specifically intended by its manufacturer to contain a specimen for the purpose of in vitro diagnostic examination is considered to be a device.

(Amendment 11)

ARTICLE 1(2)(e)

>Original text>

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

>Text following EP vote>

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

(Amendment 12)

ARTICLE 1(2)(g)

>Original text>

(g) 'authorized representative' means the natural or legal person established within the Community who, being explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community in substitution for the manufacturer with regard to the latter's obligations in accordance with this Directive;

>Text following EP vote>

(g) 'authorized representative' means the natural or legal person established within the European Union who, being explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the European Union in substitution for the manufacturer with regard to the latter's obligations in accordance with this Directive;

(Amendment 14)

ARTICLE 2

>Original text>

Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly installed, maintained and used in accordance with their intended purpose.

>Text following EP vote>

Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly supplied, installed, maintained and used in accordance with their intended purpose.

(Amendment 15)

ARTICLE 3a (new)

>Text following EP vote>

Article 3a

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

(Amendment 16)

ARTICLE 4(2)

>Original text>

2. At trade fairs, exhibitions, demonstrations, Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.

>Text following EP vote>

2. At trade fairs, exhibitions, demonstrations or scientific and technical meetings, Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.

(Amendment 17)

ARTICLE 4(3)

>Original text>

3. Member States may require, when a device reaches the final user, information, as referred to in Annex 1, point 13, to be in their national language(s) or in other Community language(s) to the extent that it is needed for safe and correct use of the device. In the application of this provision Member States shall take into account the principle of proportionality and in particular whether information can be provided by recognized symbols or codes and whether the device is intended for use by trained professionals.

>Text following EP vote>

3. When a device reaches the final user, information, as referred to in Annex 1, point 13, shall be in the national language(s). In the application of this provision Member States shall examine whether information can be provided by recognized symbols or codes and whether the device is intended for use by trained professionals or by non-professional users as in the case of in vitro self-testing reagents.

(Amendment 18)

ARTICLE 7

>Original text>

1. The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC.

>Text following EP vote>

The Commission shall be assisted by an advisory committee made up of representatives of the Member States and chaired by the Commission representative.

>Original text>

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

>Text following EP vote>

In accordance with the provisions of the 'modus vivendi' of 20 December 19941 and the procedures relating to it, the representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, as justified by public health requirements, if necessary by taking a vote.

The Commission shall take the greatest possible account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account. The opinion shall be recorded in the minutes; in addition, each member of the Committee shall have the right to ask for his position to be recorded in the minutes.

1 OJ C 293, 8.11.1995, p. 1.

>Original text>

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

>Original text>

3. The Committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive.

(Amendment 20)

ARTICLE 9(11)

>Original text>

11. By derogation from paragraphs 1 to 3, the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 3 have not been carried out and the use of which is in the interest of protection of health.

>Text following EP vote>

11. By derogation from paragraphs 1 to 3, the competent authorities may, in agreement with the national authorities concerned, authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of specific devices for which the procedures referred to in paragraphs 1 to 3 have not been carried out and the use of which is in the interest of protection of health.

(Amendment 21)

ARTICLE 10, title and (1)

>Original text>

Registration of manufacturers

>Text following EP vote>

Registration of manufacturers and devices

>Original text>

1. Any manufacturer, who places devices on the market under his own name, shall notify the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business, the categories of devices as defined in terms of common characteristics of technology and/or analytes and of any significant change thereto. The abovementioned notification shall also include any new device as referred to in Article 11(4).

>Text following EP vote>

1. Any manufacturer, who places devices on the market under his own name, shall notify the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business, the categories of devices as defined in terms of common characteristics of technology and/or analytes and of any significant change thereto. The abovementioned notification shall also include any new device as referred to in Article 11(4).

>Text following EP vote>

As a transitional requirement pending the establishment of a European Union database accessible to the competent authorities of the Member States and containing data relating to all devices in circulation in the territory of the Union, such notification shall be made by the manufacturer to the competent authorities of each Member State concerned by such placing of devices on the market.

(Amendment 23)

ARTICLE 11(3)

>Original text>

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 relevant measures have been taken or are contemplated.

>Text following EP vote>

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 relevant measures, including possible withdrawal, have been taken or are contemplated.

(Amendment 24)

ARTICLE 11(4), introduction

>Original text>

4. Where, in the context of notification referred to in Article 10, a device notified, bearing a 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 with the device subsequent to its being placed on the market. For this purpose, a device is 'new' if:

>Text following EP vote>

4. Where, in the context of notification referred to in Article 10, a device notified, bearing a 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 lessons learned with experience with the device subsequent to its being placed on the market. For this purpose, a device is 'new' if:

(Amendment 25)

ARTICLE 11(5)

>Original text>

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

>Text following EP vote>

5. The Member States shall on request inform the other Member States of the details referred to in paragraphs 1 and 4. The procedures implementing the present Article shall be adopted in accordance with the procedure referred to in Article 7(2). After they have been placed on the market, the Member States shall continuously assess the quality and safety of all in vitro medical diagnostic devices.

(Amendment 26)

ARTICLE 11(5a) (new)

>Text following EP vote>

5a. In addition, the data provided by the manufacturers in accordance with Article 10 shall be stored in a European Union database accessible to the appropriate authorities to enable them to apply informed standards of vigilance. Such data is to be forwarded in a standardized format.

(Amendment 28)

ARTICLE 13(2)

>Original text>

2. Member States shall apply the criteria set out in Annex 9 for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria.

>Text following EP vote>

2. Member States shall apply the criteria set out in Annex 9 for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the criteria applicable in accordance with the said Annex 9.

(Amendment 29)

ARTICLE 16(2)

>Original text>

2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken.

>Text following EP vote>

2. In the event of a decision as referred to in paragraph 1, the manufacturer, or his authorized representative established in the European Union, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by public health requirements.

(Amendment 30)

ARTICLE 19(1)(a)

Article 1(2)(c) (Directive 93/42/EEC)

>Original text>

(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 state, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients.

>Text following EP vote>

(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 state, pathological state or congenital abnormality or to determine the safety and compatibility with potential recipients.

(Amendment 31)

ARTICLE 19(1)(aa) (new)

Article 1(2)(h) (Directive 93/42/EEC)

>Text following EP vote>

(aa) Article 1(2)(h) shall read as follows:

"(h) placing on the market means making available for the first time, in return for payment or free of charge, a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new of fully refurbished.

>Text following EP vote>

Nothing in this Directive shall be deemed to imply that 'refurbished' includes the repair or maintenance of medical devices in accordance with the manufacturer's instructions.¨

(Amendment 32)

ARTICLE 19(1)(ab) (new)

Article 1(2)(ia) (new) (Directive 93/42/EEC)

>Text following EP vote>

(ab) In Article 1(2), the following point (ia) shall be added:

"(ia) authorized representative means the natural or legal person as established within the European Union who, being explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the European Union in substitution for the manufacturer with regard to the latter's obligations in accordance with this Directive.¨

(Amendment 33)

ARTICLE 19(1)(b)

Article 1(5)(f) (Directive 93/42/EEC)

>Original text>

(f) transplants or tissues or cells of human origin, unless a device is manufactured utilizing tissues or substances derived from such tissues which are non viable or rendered non viable. In this case, the Directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin, as well as any regulations relating to the ethics governing distribution of given types of devices of such origin.

>Text following EP vote>

(f) transplants or tissues or cells of human origin, unless a medical device is manufactured utilizing cells or tissue of human origin and having undergone a process of transformation which removes the cellular organization or the characteristic structure of the tissue of origin and renders them non viable. In this case, the Directive shall not affect national regulations relating to the ethics of the collection of tissues or substances of human origin, as well as any regulations relating to the ethics governing distribution of given types of devices of such origin.

(Amendment 34)

ARTICLE 19(1)(ba) (new)

Article 2 (Directive 93/42/EEC)

>Text following EP vote>

(ba) Article 2 shall read as follows:

'Article 2

Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they comply with the requirements laid down in this Directive when properly supplied, installed, maintained and used in accordance with their intended purpose.¨

(Amendment 35)

ARTICLE 19(1)(bb) (new)

Article 4(4) (Directive 93/42/EEC)

>Text following EP vote>

(bb) Article 4(4) shall read as follows:

"4. Member States shall require, when a device reaches the final user, information, as referred to in Annex I, point 13, to be in their national language(s).¨

(Amendment 36)

Article 19(1)(c)

Annex I (8.2), 1st subparagraph (Directive 93/42/EEC)

>Original text>

'8.2. Where a device is manufactured utilizing human tissues or substances derived from human tissues, the use of such tissues or substances must be subject to the relevant validated selection and screening procedures, including traceability as appropriate in relation to the inherent risk.

>Text following EP vote>

'8.2. Where a medical device is manufactured utilizing human tissues or cells or substances derived from human tissues, as described in Article 1(5)(f) above, the use thereof must be subject to the relevant validated selection and screening procedures, including traceability as appropriate in relation to the inherent risk.

(Amendment 37)

ARTICLE 19(1)(d)

Annex I (13.3)(n) (Directive 93/42/EEC)

>Original text>

(n) in the case of devices incorporating tissues of human origin or substances derived from such tissues, a statement indicating that the device incorporates tissue or substances derived from tissue of human origin as appropriate;

>Text following EP vote>

(n) in the case of medical devices which, during manufacture, utilize cells or tissues of human origin or substances derived from such tissues, a statement indicating that the medical device contains substances or cells of human origin;

(Amendment 38)

ARTICLE 19(1)(e)

Annex II (3.2)(c) and Annex III (3), third-last indent

(Directive 93/42/EEC)

>Original text>

- in the case of devices incorporating tissues of human or animal origin, information on the selection and origin;

>Text following EP vote>

- in the case of medical devices manufactured using substances derived from cells or tissues of human or animal origin, information on the selection and origin;

(Amendment 39)

ARTICLE 19(1)(f)

Annex IX (III) (4.5), last subparagraph (Directive 93/42/EEC)

>Original text>

All devices manufactured utilizing human tissues or substances derived from such tissues are in class III.

>Text following EP vote>

All medical devices which during their manufacture utilize cells or tissues of human origin or substances produced therefrom are in class III.

(Amendment 40)

ARTICLE 19(2)

>Original text>

2. In Directive 89/392/EEC, the text of Article 1(3), second indent 'machinery for medical use, used in direct contact with patients¨ is replaced by the following text:

>Text following EP vote>

Deleted

>Original text>

'- medical devices¨

(Amendment 41)

Annex 1(1)

>Original text>

1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety and health of users and, where applicable, other persons, and the safety of property. Any risks, which may be associated with their use, must be acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

>Text following EP vote>

1. The devices must be designed, manufactured and packaged in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety and health of users and, where applicable, other persons, and the safety of property. Any risks, which may be associated with their use, must be acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

(Amendment 42)

Annex 1(2), 2nd subparagraph, 1st indent

>Original text>

- eliminate or reduce risks as far as possible (inherently safe design and construction);

>Text following EP vote>

- eliminate or reduce risks as far as possible (inherently safe design, construction, and packaging);

(Amendment 43)

Annex 1(3)

>Original text>

3. The devices must be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1(2)(b), as specified by the manufacturer, taking account of the generally acknowledged state of the art. They must achieve the performances in particular in terms of analytical sensitivity, specificity, accuracy, repeatability, reproducibility and limits of detection stated by the manufacturer.

>Text following EP vote>

3. The devices must be designed and manufactured in such a way that they are suitable for the purposes referred to in Article 1(2)(b), as specified by the manufacturer, taking account of the generally acknowledged state of knowledge. They must achieve the performances in particular in terms of analytical sensitivity, specificity, accuracy, repeatability, reproducibility and limits of detection stated by the manufacturer.

>Original text>

The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of higher order.

>Text following EP vote>

The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of the highest order.

(Amendment 44)

Annex 1(6.1) and (6.2)

>Original text>

6.1. The devices must be designed and manufactured in such a way as to achieve the characteristics and performances referred to in Section I on the 'General Requirements¨. Attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.

>Text following EP vote>

6.1. The devices must be designed, manufactured and packaged in such a way as to achieve the characteristics and performances referred to in Section I on the 'General Requirements¨. Attention must be paid to the possibility of impairment of analytical performance due to incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms) intended to be used with the device, taking account of its intended purpose.

>Original text>

6.2. The devices must be designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by leakage products, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products.

>Text following EP vote>

6.2. The devices must be designed, manufactured and packed in such a way as to reduce to the minimum the risk posed by product leakage, contaminants and residues to the persons involved in the transport, storage and use of the devices, taking account of the intended purpose of the products.

(Amendment 46)

Annex 1(7.1)

>Original text>

7.1. The devices must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or other persons. The design must allow easy handling and, where necessary, reduce as far as possible contamination of and leakage from the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.

>Text following EP vote>

7.1. The devices must be designed in such a way as to eliminate or reduce to the minimum all risk of infection to the user or other persons provided the instructions of the manufacturer of the in vitro diagnostic medical device are followed faithfully. The design must allow easy handling and, where necessary, reduce as far as possible contamination of and leakage from the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen. The manufacturing processes must be appropriate for these purposes.

(Amendment 47)

Annex 1(7.2)

>Original text>

7.2. Where a device incorporates biological substances, the risks of infection must be reduced as far as possible by selecting appropriate donors, appropriate substances and using appropriate inactivation, conservation, test and control procedures.

>Text following EP vote>

7.2. Where a device incorporates biological substances, all risk of infection to the user or other persons must be eradicated or reduced to the minimum by selecting appropriate donors, appropriate substances and using appropriate inactivation, conservation, test and control procedures and provided that the instructions of the manufacturer of the in vitro diagnostic medical device are followed faithfully.

(Amendment 48)

Annex 1(7.5)

>Original text>

7. 5 Packaging systems for devices other than those referred to in section 7.3 must keep the product without deterioration at the level of cleanliness, if any, as indicated by the manufacturer and, if the devices are to be sterilized prior to use, reduce as far as possible the risk of microbial contamination.

>Text following EP vote>

7. 5 Packaging systems for devices other than those referred to in section 7.3 must keep the product without deterioration at the level of cleanliness, if any, as indicated by the manufacturer and, if the devices are to be sterilized prior to use, reduce to the minimum the risk of microbial contamination.

>Original text>

Steps shall be taken to reduce microbial contamination during selection and handling of raw materials, manufacture, storage and distribution where the performance of the device can be adversely affected by such contamination.

>Text following EP vote>

Steps shall be taken to reduce microbial contamination to the maximum extent possible during selection and handling of raw materials, manufacture, packaging, storage and distribution where the performance of the device can be adversely affected by such contamination.

(Amendment 49)

Annex 1(8.3) and (8.4)

>Original text>

8.3. Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of fire or explosion during normal use. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion.

>Text following EP vote>

8.3. Devices must be designed, manufactured and packaged in such a way as to reduce as far as possible the risks of fire or explosion during normal use. Particular attention must be paid to devices whose intended use includes exposure to or use in association with flammable substances or substances which could cause combustion.

>Original text>

8.4. Devices must be designed and manufactured in such a way as to facilitate the management of safe waste disposal.

>Text following EP vote>

8.4. Devices must be designed, manufactured and packaged in such a way as to facilitate the management of safe waste disposal.

(Amendment 50)

Annex 1(12), introduction and (1)

>Original text>

Devices for self-testing must be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user.

>Text following EP vote>

Devices for self-testing must be designed, manufactured and packaged in such a way that they perform appropriately for their intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in users' technique and environment. The information and instructions provided by the manufacturer should be easily understood and applied by the user.

>Original text>

12. 1 Devices for self-testing must be designed and manufactured in such a way as to reduce as far as practicable the risk of user's error in handling and in interpretation of the result.

>Text following EP vote>

12. 1 Devices for self-testing must be designed, manufactured and packaged in such a way as to reduce as far as practicable the risk of user's error in handling and in interpretation of the result.

(Amendment 54)

Annex 1(13.7)(s), second indent

>Original text>

- specific particulars may be omitted provided that the other information supplied by the manufacturer is sufficient to enable the user to use the device and to understand the result(s) produced by the device;

>Text following EP vote>

- specific particulars may be omitted only on condition that the other information supplied by the manufacturer is sufficient to enable the user to know how to use the device and to understand the result(s) produced by the device;

(Amendment 55)

Annex 2(1)

>Original text>

1. Reagents and reagent products for blood grouping (A B O system and Rh./D)

>Text following EP vote>

1. Reagents and reagent products for blood grouping (A B O system and Rh./D) and HLA tissue compatibility

(Amendment 56)

Annex 2(2)

>Original text>

2. Reagents and reagent products for the detection in human specimens of markers of HIV infection, Hepatitis B and C.

>Text following EP vote>

2. Reagents and reagent products for the detection in human specimens of markers of HIV infection, Hepatitis B and C, Rubella and toxoplasma parasitosis.

(Amendment 57)

Annex 2(2a) (new)

>Text following EP vote>

2a. In vitro diagnostic reagents for own use.

(Amendment 71)

Annex 2(2b) (new)

>Text following EP vote>

2b. Reagents and reagent products of biological origin for the diagnosis of genetic diseases, the detection and dosage of tumorous markers and the dosage of hormones.

(Amendment 58)

Annex 7(3.2), 3rd subparagraph (d)

>Original text>

(d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment.

>Text following EP vote>

(d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the equipment used; the calibration of this equipment must be such as to guarantee adequate traceability.

Legislative resolution embodying Parliament's opinion on the proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices (COM(95)0130 - C4-0152/95 - 95/0013(COD))

(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to Parliament and the Council, COM(95)0130 - 95/0013(COD) ((OJ C 172, 7.7.1995, p. 21.)),

- having regard to Articles 189b(2) and 100a of the EC Treaty pursuant to which the Commission submitted the proposal to Parliament (C4-0152/95),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on Economic and Monetary Affairs and Industrial Policy and the opinions of the Committee on Budgets and the Committee on the Environment, Public Health and Consumer Protection (A4-0031/96),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts in accordance with Article 189b(2) of the EC Treaty;

4. Should the Council intend to depart from the text approved by Parliament, calls on the Council to notify Parliament and requests that the conciliation procedure be initiated;

5. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

6. Instructs its President to forward this opinion to the Council and Commission.