- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
eliminate or reduce risks as far as possible (inherently safe design and construction),
where appropriate take adequate protection measures in relation to risks that cannot be eliminated,
inform users of the residual risks due to any shortcomings of the protection measures adopted.
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 a higher order.
Steps must be taken to reduce as far as possible 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.
the risk of injury linked to their physical features (in particular aspects of volume × pressure, dimension and, where appropriate, ergonomic features),
risks linked to reasonably foreseeable external influences, such as magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature or variations in pressure or acceleration or accidental penetration of substances into the device.
Devices must be designed and manufactured in such a way as to provide an adequate level of intrinsic immunity of electromagnetic disturbance to enable them to operate as intended.
designed and manufactured in such a way as to ensure that the characteristics and the quantity of radiation emitted can be controlled and/or adjusted,
fitted with visual displays and/or audible warnings of such emissions.
Where there are risks due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances, then appropriate protection means must be incorporated.
Any guards or other means included with the device to provide protection, in particular against moving parts, must be secure and must not interfere with access for the normal operation of the device, or restrict routine maintenance of the device as intended by the manufacturer.
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.
ensure that the device is easy to use by the intended lay user at all stages of the procedure, and
reduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results.
This information comprises the data on the label and in the instructions for use.
As far as practicable and appropriate, the information needed to use the device safely and properly must be set out on the device itself and/or, where appropriate, on the sales packaging. If individual full labelling of each unit is not practicable, the information must be set out on the packaging and/or in the instructions for use supplied with one or more devices.
Instructions for use must accompany or be included in the packaging of one or more devices.
In duly justified and exceptional cases no such instructions for use are needed for a device if it can be used properly and safely without them.
[X1The decision whether to translate the instructions for use and the label into one or more languages of the European Union shall be left to the Member States, except that, for devices for self-testing, the instructions for use and the label must include a translation into the official language(s) of the Member State in which the device for self-testing reaches its final user.]
Editorial Information
The provisions of the aforementioned Directives on the safety data sheet shall apply, unless all relevant information as appropriate is already made available by the instructions for use.
the name or trade name and address of the manufacturer. For devices imported into the Community with a view to their distribution in the Community, the label, the outer packaging, or the instructions for use shall contain in addition the name and address of the authorised representative of the manufacturer;
the details strictly necessary for the user to uniquely identify the device and the contents of the packaging;
where appropriate, the word ‘STERILE’ or a statement indicating any special microbiological state or state of cleanliness;
the batch code, preceded by the word ‘LOT’, or the serial number;
if necessary, an indication of the date by which the device or part of it should be used, in safety, without degradation of performance, expressed as the year, the month and, where relevant, the day, in that order;
in case of devices for performance evaluation, the words ‘for performance evaluation only’;
where appropriate, a statement indicating the in vitro use of the device;
any particular storage and/or handling conditions;
where applicable, any particular operating instructions;
appropriate warnings and/or precautions to take;
if the device is intended for self-testing, that fact must be clearly stated.
the details referred to in section 8.4 with the exception of points (d) and (e);
composition of the reagent product by nature and amount or concentration of the active ingredient(s) of the reagent(s) or kit as well as a statement, where appropriate, that the device contains other ingredients which might influence the measurement;
the storage conditions and shelf life following the first opening of the primary container, together with the storage conditions and stability of working reagents;
the performances referred to in section 3 of part A;
an indication of any special equipment required including information necessary for the identification of that special equipment for proper use;
the type of specimen to be used, any special conditions of collection, pre-treatment and, if necessary, storage conditions and instructions for the preparation of the patient;
a detailed description of the procedure to be followed in using the device;
the measurement procedure to be followed with the device including as appropriate:
the principle of the method,
the specific analytical performance characteristics (e.g. sensitivity, specificity, accuracy, repeatability, reproducibility, limits of detection and measurement range, including information needed for the control of known relevant interferences), limitations of the method and information about the use of available reference measurement procedures and materials by the user,
the details of any further procedure or handling needed before the device can be used (for example, reconstitution, incubation, dilution, instrument checks, etc.),
the indication whether any particular training is required;
the mathematical approach upon which the calculation of the analytical result is made;
measures to be taken in the event of changes in the analytical performance of the device;
information appropriate to users on:
internal quality control including specific validation procedures,
the traceability of the calibration of the device;
the reference intervals for the quantities being determined, including a description of the appropriate reference population;
if the device must be used in combination with or 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 and proper combination;
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 device operates properly and safely; information about safe waste disposal;
details of any further treatment or handling needed before the device can be used (for example, sterilisation, final assembly, etc.);
the necessary instructions in the event of damage to the protective packaging and details of appropriate methods of resterilisation or decontamination;
if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and resterilisation or decontamination, and any restriction on the number of reuses;
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.;
precautions to be taken against any special, unusual risks related to the use or disposal of the device including special protective measures; where the device includes substances of human or animal origin, attention must be drawn to their potential infectious nature;
specifications for devices for self-testing:
the results need to be expressed and presented in a way that is readily understood by a lay person; information needs to be provided with advice to the user on action to be taken (in case of positive, negative or indeterminate result) and on the possibility of false positive or false negative result,
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,
the information provided must include a statement clearly directing that the user should not take any decision of medical relevance without first consulting his or her medical practitioner,
the information must also specify that when the device for self-testing is used for the monitoring of an existing disease, the patient should only adapt the treatment if he has received the appropriate training to do so;
date of issue or latest revision of the instructions for use.
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[F1,]
[F2variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation.]
Textual Amendments
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.
a general description of the product, including any variants planned,
the documentation of the quality system,
design information, including the determination of the characteristics of the basic materials, characteristics and limitation of the performance of the devices, methods of manufacture and, in the case of instruments, design drawings, diagrams of components, sub-assemblies, circuits, etc.,
in the case of devices containing tissues of human origin or substances derived from such tissue, information on the origin of such material and on the conditions in which it was collected,
the descriptions and explanations necessary to understand the abovementioned characteristics, drawings and diagrams and the operation of the product,
the results of the risk analysis and, where appropriate, a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,
in the case of sterile products or products with a special microbiological state or state of cleanliness, a description of the procedures used,
the results of the design calculations and of the inspections carried out, etc.,
if the device is to be combined with other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when combined with any such device(s) having the characteristics specified by the manufacturer,
the test reports,
adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available), with information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used; such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references,
the labels and instructions for use,
the results of stability studies.
The system shall address:
the organisational structure and responsibilities,
the manufacturing processes and systematic quality control of production,
the means to monitor the performance of the quality system.
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 other persons or to a serious deterioration in his or their state of health;
any technical or medical reason connected with the characteristics or the performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.
It shall include:
test reports including, where appropriate, results of studies carried out with lay persons,
data showing the handling suitability of the device in view of its intended purpose for self-testing,
the information to be provided with the device on its label and its instructions for use.
The manufacturer shall affix the CE marking in accordance with Article 16 and shall draw up a declaration of conformity covering the devices concerned.
The application must include:
the name and address of the manufacturer and any additional manufacturing site covered by the quality system,
adequate information on the device or device category covered by the procedure,
a written declaration that no such application has been lodged with any other notified body for the same device-related quality system,
the documentation on the quality system,
an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,
an undertaking by the manufacturer to keep the approved quality system adequate and efficacious,
an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex III, section 5.
It shall include in particular an adequate description of:
the manufacturer's quality objectives;
the organisation of the business and in particular:
the organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of design and manufacture of the devices is concerned,
the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of devices which fail to conform;
the procedures for monitoring and verifying the design of the devices and in particular:
a general description of the device, including any variants planned,
all documentation referred to in Annex III, section 3, indents 3 to 13,
in the case of devices for self-testing, the information referred to in Annex III, section 6.1,
the techniques used to control and verify the design and the processes and systematic measures which will be used when the devices are being designed;
the inspection and quality assurance techniques at the manufacturing stage and in particular:
the processes and procedures which will be used, particularly as regards sterilisation,
the procedures in relation to purchasing,
the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
the appropriate tests and trials which will 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 to trace back the calibration.
The manufacturer shall carry out the required controls and tests according to the latest state of the art. The controls and tests shall cover the manufacturing process including the characterisation of the raw material and the individual devices or each batch of devices manufactured.
In testing the devices covered by Annex II, List A, the manufacturer shall take into account the most recent available information, in particular as regards the biological complexity and variability of the specimens to be tested with the in vitro device concerned.
The assessment team must have experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.
The decision shall be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.
the documentation on the quality system,
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculation, tests, etc.,
the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
The application shall include:
the name and the address of the manufacturer and the name and address of the authorised representative if the application is lodged by the representative,
the documentation described in section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the ‘type’, with the requirements of this Directive. The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary,
a written declaration that no application has been lodged with any other notified body for the same type.
a general description of the type, including any variants planned,
all documentation referred to in Annex III, section 3, indents 3 to 13,
in the case of devices for self testing, the information referred to in Annex III, section 6.1.
Other notified bodies may obtain a copy of the EC type-examination certificates and/or the supplements thereto. The annexes to the certificates must be available to the other notified bodies on reasoned application, after the manufacturer has been informed.
In as far as the conduct of examinations and tests on a statistical basis is not appropriate, examinations and tests may be carried out on a random basis provided that such procedure in conjunction with the measures taken in accordance with section 2.2 ensures an equivalent level of conformity.
If the batch is rejected the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.
The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.
The manufacturer must affix the CE marking in accordance with Article 16 and draw up a declaration of conformity covering the devices concerned.
The application must include:
the technical documentation on the types approved and a copy of the EC type-examination certificates.
All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records.
It must include in particular an adequate description of:
the manufacturer's quality objectives;
the organisation of the business and in particular:
the organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of manufacture of the devices is concerned,
the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of devices which fail to conform;
the inspection and quality assurance techniques at the manufacturing stage and in particular:
the processes and procedures which will be used, particularly as regards sterilisation,
the procedures in relation to purchasing,
the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
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 to trace back the calibration.
The assessment team must have past experience of assessments of the technology concerned. The assessment procedure must include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.
The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
The notified body must assess the changes proposed and verify whether after these changes the quality system still meets the requirements referred to in section 3.2. It must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.
The provision of Annex IV, section 5, shall apply.
data allowing identification of the device in question,
an evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned,
the list of laboratories or other institutions taking part in the evaluation study,
the starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved,
a statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
The manufacturer shall take all the measures necessary for the manufacturing process to ensure that the products manufactured conform to the documentation mentioned in the first paragraph.
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 the Directive. 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 this Directive.
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.
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 5 mm. This minimum dimension may be waived for small-scale devices.
OJ L 39, 15.2.1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ L 357, 7.12.1989, p. 28).
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). Directive as last amended by Commission Directive 97/69/EC (OJ L 343, 13.12.1997, p. 19).
Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 187, 16.7.1988, p. 14). Directive as last amended by Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15).
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