Opinion on the proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices ()

(96/C 18/02)

On 29 September 1995 the Council decided to consult the Economic and Social Committee, under Article 100a of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Protection of the Environment, Public Health and Consumer Affairs, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 19 September 1995. The Rapporteur was Mr Fuchs.

At its 329th Plenary Session (meeting of 25 October 1995), the Economic and Social Committee unanimously adopted the following Opinion.

The Economic and Social Committee endorses the Commission proposal subject to the following considerations and comments.

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1. Introduction

1.1. As part of the programme to complete the internal market, the rules for placing medical devices on the market are being harmonized throughout the Community to protect patients, users and third parties. Most medical devices are covered already by the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC).

1.2. The present draft Directive supplements the existing legislation. It covers in vitro diagnostic medical devices which, in view of their special nature, need specific provisions.

1.3. The proposal is based on Article 100a of the Treaty and applies the principles of the new approach to technical harmonization. It lays down the essential requirements which devices placed on the market must meet, and the conformity assessment procedures with which manufacturers must comply. It refers to standards to be established by the CEN/CENELEC for the technical formulation of these requirements.

1.4. At the administrative level, the task of implementation is reserved for the Member States, who will be responsible for monitoring the market in cooperation with the authorities in other Member States, appointing the certification bodies (notified bodies) and monitoring the activities of such bodies.

2. General comments

2.1. By way of introduction, the Committee vigorously endorses the proposal that, at the administrative level, the implementation of the in vitro diagnostic medical devices Directive should remain in the hands of the Member States. The Committee sees this as a further indication that the concept of subsidiarity has been correctly understood by the Commission. The impact of the new approach to harmonization is discernible.

2.1.1. The Committee agrees with the definition of 'in vitro diagnostic medical devices' as, essentially, reagents, instruments and equipment for examining tissues or substances from the human body for medical purposes.

2.1.2. In contrast to procedures which take place on or in the human body, in vitro diagnostic devices are used outside the human body for medical examination of samples taken from the patient and can be utilized to diagnose illnesses, monitor patients' state of health, check the progress of courses of treatment and a whole series of other medical applications. Users of these devices are mainly medical laboratories, doctors, pathologists and medical scientists, although some of them are intended to be used by the patients themselves (e.g. pregnancy tests).

2.1.3. Calibrators and control material used in combination with in vitro diagnostic medical devices, such as reagents and equipment, are also considered to be in vitro diagnostic devices. The same applies to laboratory equipment specifically intended for use in medical laboratories conducting in vitro examinations.

2.1.4. The Committee notes however that the proposal 'does not apply to devices, in particular reagents, manufactured by laboratories for their own needs without any transaction with other users'. The Committee would point out that the manufacturer of special diagnostic reagents by medical laboratories themselves occurs only in exceptional cases. It may, however, be quite useful for laboratories to produce their own simple reagents, such as particular reagent solutions, using basic chemicals. Such a course of action does not give rise to any reservations on grounds of safety, bearing in mind the technical expertise of the laboratory staff. The inclusion within the Directive of reagents produced by laboratories would also give rise to problems of differentiation since neither the provisions governing product quality assurance in manufacture, nor those in respect of characteristics, could properly be applied to such products.

2.2. Disparities of legislation

2.2.1. The Committee appreciates the care which has gone into preparing the draft Directive. Before starting the harmonization work, the Commission conducted a study in 1991 to compare and analyze several Member States' legislation on this subject. The study revealed big differences between the requirements imposed on the devices by the national regulatory systems, particularly with regard to labelling, authorization or registration procedures and production control.

2.2.2. The current disparities between national regulatory systems, plus any disparities which would arise following the adoption of further national legislation in the absence of European harmonization, create barriers to the free movement of these devices in the Community, making it virtually impossible to establish any equivalence between the various national provisions in terms of health protection. From an economic point of view, there is a danger that the lack of harmonized legislation could hamper the development of this industry in the Community.

2.2.3. The Committee is pleased that more than four years of hearings and consultations took place before the Directive was finally drafted and this has arguably helped to ensure that the draft Directive is a balanced and well-thought-out proposal.

2.3. Essential requirements

2.3.1. In the interests of patients and users, the Committee welcomes the aim of ensuring that devices placed on the market comply with the essential requirements set out in Annex 1 to ensure a high level of health and safety protection. Devices must be designed and manufactured to achieve the performances stated by the manufacturer and to be able to be used for the intended medical purpose, taking account of the generally recognized state of the art. The essential requirements are also designed to protect users and third parties in particular against the risks posed by the physical and chemical properties of the devices and against the biological, mechanical, thermal, electrical and radiation risks posed by any energy source with which they are equipped. This objective is likewise endorsed by the Committee.

2.3.2. The Committee shares the view that devices for self-testing must be designed to take into account the skills and means available to users. Particular attention must be paid to the clarity of the information and instructions accompanying the devices.

2.3.3. The draft Directive stipulates that in vitro diagnostic medical devices have to be suitable for the intended purpose, taking account of the acknowledged state of the art. The performance parameters which have to be met in this respect relate exclusively to analytical characteristics. The Committee notes that the draft Directive does not yet provide for examination of the diagnostic value of in vitro diagnostic medical devices, a value which is roughly equivalent to, for example, the proof of effectiveness in the case of medicinal products. As a consequence, free rein is also given to the marketing of in vitro diagnostic medical devices which can make no contribution towards an effective medical diagnosis.

2.4. Conformity assessment

The Committee notes that the conformity assessment procedures cover a very wide range of devices and highly different circumstances and conditions. Given this complexity, the Commission proposals are acceptable. Looking at the detail of the proposal the Committee notes that:

2.4.1. The proposal is aligned on the wording for conformity assessment procedures in Directive 93/42/EEC, taking account of the specific nature of in vitro diagnostic devices and of the manufacture thereof. For devices placed on the market solely on the manufacturer's responsibility, manufacturers must follow the principles of quality assurance and provide technical documentation containing proof that they have tested the performance of the devices. This helps to ensure that the results are valid and the devices safe to apply.

2.4.2. Devices for self-testing are of special importance. Here the intervention of a notified body is necessary. This body must concentrate on verification and on the performance of the devices under the conditions in which they would normally be used, taking account of the intended user. The Committee is pleased that this procedure is likely to avoid the unnecessary extension of controls. It is important in this respect that self-testing devices should be classified differently from products used by qualified health professionals in the home of the patient.

2.4.3. The intervention of a notified body is also necessary in respect of the certification of the design and manufacturer of various categories of products listed in Annex 2, such as a test to determine blood groups or detect HIV infection; in this context Council Decision No 90/683/EEC stipulates that manufacturers may choose between various procedures. The Committee considers it important that, under this method, the manufacturer has room for manoeuvre and retains responsibility for selecting the appropriate procedure, depending on the particular problems and devices.

2.4.4. The proposal allows amendments of the list of devices in Annex 2, with the assistance of a regulatory committee, for those cases in which devices for new uses cannot provide sufficient guarantee of the reliability of their performance. The Committee believes that this also satisfies concerns about protecting the consumer and user. The Committee nevertheless considers that notification must remain the rule. Amending Annex 2 with the assistance of a regulatory committee must be something done only in quite exceptional circumstances.

2.5. Monitoring

2.5.1. The Committee attaches particular importance to monitoring. The proposal provides for mechanisms to monitor the market, notably via vigilance procedures, and for measures to protect the public interest. Monitoring is possible because all manufacturers are required to inform the competent authorities of the Member State where they have their registered place of business of the categories of devices which they market. The proposal also specifies that notification is required for new devices. The vigilance procedure implies that manufacturers will have to give notification of any malfunction of the devices which could affect patients' and users' health. The Committee also welcomes the provision that, as part of the monitoring process, account must be taken of notifications of malfunctions of the devices passed on by the medical profession, medical establishments and, in particular, the organizers of external quality assessment programmes. The Committee considers that, on the strength of these measures, adequate attention has been paid to the need for vigilance, protection of the public interest and subsidiarity.

2.6. Special arrangements

2.6.1. The proposal makes special arrangements for in vitro diagnostic medical devices intended for medical use of which the precise performance has yet to be verified and confirmed. The status of these devices must be indicated on the label and the manufacturer must follow a special conformity procedure. The Committee likewise welcomes this proposal.

3. Specific comments

3.1. The Committee is aware that the Commission proposal focuses on rules for placing in vitro diagnostic devices on the market. Implementation of the Directive and user monitoring remain in the hands of the Member States. Systematic monitoring of the accuracy of the analyses carried out is particularly important in connection with the use of in vitro diagnostic medical devices. Inaccurate analyses have called into question the comparability of measurements; this in turn has resulted in unnecessary duplication of analyses, with the attendant strain on patients and additional costs to the social security system.

3.1.1. Accurate findings from analyses can be achieved only if the correct calibrators, which are available from a number of manufacturers, are used. Users monitor the accuracy of their findings by carrying out analyses on control materials, which are also available on the market ('internal' quality assurance). It is thus quite logical for calibrators and control materials for 'internal' quality assurance to fall within the scope of the Directive.

3.1.2. The accuracy of analyses carried out in medical laboratories may also be effectively checked by 'external' quality assurance measures, which also involves the use of control materials. These materials are distributed on a centralized basis by the organizers and then analyzed in the individual laboratories. The Committee notes that control materials for external quality assurance are expressly excluded from the scope of the draft Directive. This should be reviewed, at least in respect of stable control materials, which are frequently in no way different from those used for internal monitoring. In the Committee's view, the Directive should embrace all control materials, irrespective of the way in which they are used in medical laboratories. Exceptions may be made in the case of preparations using fresh blood, which can only be conserved for limited periods.

3.1.3. Bearing in mind the importance of calibrators and control materials, it is stipulated in Annex 1 ('Essential requirements') that the traceability of these materials must be assured through reference measurement procedures and reference materials of higher order. The level of stringency of this traceability is however not specified. Furthermore, no provisions whatsoever are laid down with regarded to the body which is to be responsible for determining the reference measurement procedures and reference materials. In the Committee's view the provisions should be further tightened through the establishment of a standard by the European standards bodies CEN/CENELEC, in order to take account more effectively of the traceability requirement.

3.1.4. In the Committee's view, it is important for users to continue to participate in the work of the working parties concerned in any future further development of the Directive on in vitro diagnostic medical devices.

3.2. The 'essential requirements' laid down in Annex 1 stipulates, inter alia, that 'each device must be accompanied by the information needed to use it properly, taking account of the training and knowledge of the potential users and to identify the manufacturer'. The Committee considers that - particularly for self-testing devices - the 'instructions for use' should be in the language of the target country, so that they could be understood by the users. Instructions for use in the principal languages of the EU are adequate only for devices normally operated by particularly qualified specialists.

3.3. The draft Directive stipulates that the manufacturer of groups of reagents and reagent products particularly those listed in Annex 2, shall, in order to affix the CE-marking, be able to choose solely between the procedure relating to the EC declaration of conformity set out in Annex 4, or the procedure relating to EC type examination set out in Annex 5. The Committee notes that this applies only to reagents or reagent products which could have serious consequences for third persons if they do not function properly, e.g. products used in connection with blood transfusions.

3.4. The German version of the draft Directive under review (COM(95) 130 final - 95/0013 COD) contains a translation error which distorts the meaning of the text, in Annex 1, Section II, point 13.7 (page 51). The English text reads as follows: 'the reference intervals for the quantities being determined'. The German translation should accordingly be amended to read as follows: 'die Referenzintervalle fuer die zu bestimmende Messgroesse' rather than 'die Zeitabstaende fuer die Bestimmung der Mengen' (the intervals for determining the quantities).

Done at Brussels, 25 October 1995.

The President

of the Economic and Social Committee

Carlos FERRER

() OJ No C 130, 7. 7. 1995, p. 21.