Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas measures should be adopted in the context of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;
Whereas the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices are different; whereas the certification and inspection procedures for such devices differ from one Member State to another; whereas such disparities constitute.barriers to trade within the Community;
Whereas the national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonized in order to guarantee the free movement of such devices within the internal market;
Whereas the harmonized provisions must be distinguished from the measures adopted by the Member States to manage the funding of public health and sickness insurance schemes relating directly or indirectly to such devices; whereas, therefore, the provisions do not affect the ability of the Member States to implement the abovementioned measures provided Community law is complied with;
Whereas 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;
Whereas certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary
medicinal products (4); whereas, in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65j65jEEC; whereas if, however, such a device is placed on the market in such a way that the device and the ~QlcinaL ~ form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by ~ Dire9=ive 65j6~jEEC; whereas a distinction must be drawn between the abovementioned '~evices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of Directive 65j65jEEC; whereas in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive; whereas, in this context, the safety, quality and usefulness of the substances must be verified by analogy Jo.
with the appropriate methods specified in Council Directive 75j318jEEC of 20 May 1975 7' on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (5); -; ---------
Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to 'minimizing' or 'reducing' risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;
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 (6), rules regarding the design and manufacture of medical devices 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 should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety;
Whereas Council Directive 90j385jEEC of 20 June 1990 on the approximation of the laws of the Mem6er States relating to active implantable medical devices (7) is the first case of application of the new approacn to the field of medical devices; whereas in the interest of uniform Community rules applicable to all medical devices, this Directive is based largely on the provisions of Directive 90j385jEEC; whereas for the same reasons Directive 90j385jEEC must be amended to insert the general provisions laid down in this Directive;
Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices; whereas this Directive should contain specific rules on this subject with regard to Council Directive 89j336jEEC of 3 May 1989 on the approximation of the laws of the Member States reiatTngto electromagnetic compatibility (8);
.-- ----- -
Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not affect the authorization required by Council Directive 80j836jEuratom of 15 July 1980 amending the Directives laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation (9), nor application of Council Direct~j466jEuratom ~tember 1~4 laying down basic measures for the radiation pr6tectl~-of person~~medical ~ation ~~t (10);
~s Council Directive 89j391jEEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (11) and the specific directives on the same subject should continue to apply;
Whereas, in order to demonstrate conformity with the essential requirements and to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; whereas such harmonized European standards are drawn up by privatelaw bodies and should retain their status as non-mandatory texts; whereas, to this end,
the European Committee for Standardization ~CENLand the European Committee for Electrotechnical Standardization (Cenelec) are recognized as the competent bodies for the adoption of harmonized standards in accordance with the general guidelines on cooperation between the Commission and these two bodies signed on 13 November 1984;
Whereas, for the purpose of this Directive, a harmonized ~rd is a technical specification (European standard or harmoffiation document) adopted,~andate from the Commission, by either or both of these bodies in accordance with Council Directive 83j189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations (12), and pursuant to the abovementioned general guidelines; whereas with regard to possible amendment of the harmonized standards, the Commission should be assisted by the Committee set up pursuant to Directive 83j189jEEC; whereas the measures to be taken must be defined in line with procedure I, as laid down in Council Decision 87j373jEEC (13); whereas, for specific fields, what already exists in the form of E.J.ropean Pharmacopo~a .!:no~nographs * should be incorporated within the framework of ~his Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovementioned harmonized standards;
Whereas, in Decision 90j683jEEC of 13 December 1990 concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives (14), the Council has laid down harmonized conformity assessment procedures; whereas the application of these modules to medical devices e.nables t~e re~bility of manufacturers and no~bodies to be determined uring c~'assessment procedures on the basis of the type of devices concerned;
Vvh e s the e arrSadded to these rilOdUreS are justified by the nature of the verification required for medical devices;
Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of th€"manutacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the · intervention of a notified body should be compulsory at th'eProduction stage; whereas, & fcrraevlces failing within Classes IIb and III which constltutea1iigh risk potential, lJ!) inspection by a notified body is requlreCfWltfl regaratOthe design and manufacture of the aevrces; whereas Class III IS se~r tFie most critical devices for which explicit prior authorization witKregard to conformity is required for them to bep~~et;
Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in J -¥ emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose; -
Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose;
Whereas, in the fight against AIDS and in the light of the conclusions of the Council J adopted on 16 May 1989 regarding future activities on AIDS prevention and control at .J[ Community level (15), medical devices used for protection against the HIV virus must -If" afford a high level of protection; whereas the design and manufacture of such products should be verified by a notified body;
Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers
conferred on the Commission the decisions to be taken with regard to the proper classification or reclassification of the devices or, where appropriate, the adjustment of the classification rules themselves; whereas since these issues are closely connected with the protection of health, it is appropriate that these decisions should come under procedure IlIa, as provided for in Directive 87/373/EEC;
c:::-------- ..--- .....
Whereas the confirmation of complicance with the essential requirements may mean that 'J .
clinical investigations have to be carried out under the responsibility of the manufacturer; C /Z.O whereas, for the purpose of carrying out the clinical investigations, appropriate means have to be specified for the protection of public health and public order; "-
Whereas the protection of health and the associated controls may be made more effective by means of medical device vigilance systems which are integrated at Community level;
Whereas this Directive covers the medical devices referred to in Council Directive ~ on the approximation of the laws of the Member States on ~ 'tfinical mercu - - la s maximum reading thermome.!§rs (16); whereas the }"\ '~ntioned Directive mus ereforebe repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine (17) must be amended, -- ~
HAS ADOPTED THIS DIRECTIVE:
1. This Directive shall apply to medical devices and their accessories. For the purposes of -* this Directive, ac ssor' s shall be treatecLas medical devices in their own right. Both medical devices nd accessories shall ~einafter 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, whe~bination, 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 of 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) 'accessolY' means an article which whilst not being a device is intended specifically by
its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
(c) 'device used for in vitro diagnosis' means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;
(d) 'custom-made device' means any device specifically made in accordance with a duly qua~oner's written prescription which gives, under his responsibility, speCific design characteristics and is intended for the sole use of a particular patient.
The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custommade devices;
(e) 'device intended for clinical investigation' means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
(f) ~ 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 a device 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) '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 and/or in promotional materials;
(h) '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 clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
(i) 'putting into service' means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product.
If, however, such a device is placed on the market in such a way that the device and the 2 f medicinal product form a single integral product which is intended exclusively for use in f ~ the given combination and which is not reusable, that single product shall be governed by IV Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.
4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.
5. This Directive does not apply to:
(a) in vitro diagnostic devices;
(b) active implantable devices covered by Directive 90/385/EEC;
(c) medicinal products covered by Directive 65/65/EEC;
(d) cosmetic products covered by Directive 76/768/EEC (18);
(e) human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells;
(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin;
(g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product.
7. This Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336jEEC.
8. This Directive does not affect the application of Directive 80/836/Euratom, nor of Directive 84/466/Euratom.
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 put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.
The 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.
Free movement, devices intended for special purposes
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.
2. Member States shall not create any obstacle to:
- devices intended for clinical investigation being made available to medical practitioners or authorized persons for that purpose if they meet the conditions laid down in Article 15 and in Annex VIII,
- custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, lIb and III devices shall be accompanied by the statement referred to in Annex VIII.
These devices shall not bear the CE marking.
3. At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a
- an investigation plan statin~~ in particular the purpose! scientific! technical or medical grounds, scope and number of devices concerned!
- the opinion of the ethics committee concerned and details of the aspects covered by its opinion!
- the name of the medical practitioner or other authorized person and of the Institution responsible for the investigations!
- the place! starting date and scheduled duration for the investigations!
- a statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that! with regard to these aspects!
every precaution has been taken to protect the health and safety of the patient.
3. The manufacturer must also undertake to keep available for the competent national authorities:
3.1. for custom-made devices, documentation allowing an understanding of the design! manufacture and performances of the product! including the expected performances! so as to allow assessment of conformity with the requirements of this Directive.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;
3.2. for devices intended for clinical investigations! the documentation must contain:
- a general description of the product,
- design drawings! methods of manufacture envisaged! in particular as regards sterilization! and diagrams of components! sub-assemblies, circuits! etc.!
- the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product!
- the results of the risk analysis and 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 this Directive if the standards referred to in Article 5 have not been applied!
- the results of the design calculations! and of the inspections and technical tests carried out! ete.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.
The manufacturer must authorize the assessment! or audit where necessary! of the effectiveness of these measures.
4. The information contained in the declarations concerned by this Annex should be kept for a period of time of at least five years.
ANNEX IX *
CLASSIFICATION CRITERIA 1. DEFINITIONS 1. Definitions for the classification rules
Transient Normally intended for continuous use for less than 60 minutes.
Normally intended for continuous use for not more than 30 days.
Long term Normally intended for continuous use for more than 30 days.
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A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body.
Any natural opening in the body, as well as the external !;urface of the eyeball, or any permanent artificial opening, such as a stoma.
Surgically invasive device
An invasive device which penetrates inside the body throu~lh the surface of the body, with the aid or in the context of a surgical operation.
For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as sur~Jically invasive devices.
Any device which is intende(j:
- to be totally introduced into the human body or,
- to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.
1.3. Reusable surgical instrument
Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out.
1.4. Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices.
1.5. Active therapeutical device
Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.
1.6. Active device for diagnosis
Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating
physiological conditions, states of health, illnesses or congenital deformities.
1.7. Central circulatory system
For the purposes of this Directive, 'central circulatory system' means the following vessels:
arteriae pulmonales, aorta ascendens, arteriae cor-onariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachicephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.
1.8. Central neNOUS system
For the purposes of this Directive, 'central neNOUS system' means brain, meninges and spinal cord.
II. IMPLEMENTING RULES 2. Implementing rules
2.1. Application of the classification rules shall be ~Joverned by the intended purpose of the devices.
2.2. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.
2.3. Software, which drives a device or influences the use of a device, falls automatically in the same class.
2.4. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of Ule most critical specified use.
2.5. If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the hl~Jher classification shall apply.
III. CLASSIFICATION 1. Nonninvasive devices
1.1. Rule 1
All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies.
1.2. Rule 2
All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa:
- if they may be connected to an active medical device in Class IIa or a higher class,
- if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues,
in all other cases they are in Class I.
1.3. Rule 3
All non-invasive devices intended for modifying the bioloqical or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class lIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class IIa.
1.4. Rule 4
All non-invasive devices which come into contact with injured skin:
.. are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
- are in Class lIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,
- are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.
2. Invasive devices
2.1. Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device:
- are in Class I if they are intended for transient use,
- are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,
- are in Class lIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and.
are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.
2.2. Rule 6
All surgically invasive devices intended for transient use are in Class IIa unless they are:
- intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
- reusable surgical instruments, in which case they are in Class I,
- intended to supply enet"gy in the form of ionizing radiation in which case they are in Class lIb,
- intended to have a biological effect or to be wholly or mainly absorbed in which case they are in Class lIb,
- intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking pccount of the mode of application, in which they are in Class lIb.
2.3. Rule 7
All surgically invasive devices intended for short-term use are in Class IIa unless they are intended:
- either specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
- or specifically for use in direct contact with the central nervous system, in which case they are in Class III,
- or to supply energy in the form of ionizing radiation in which case they are in Class lIb,
- or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III,
- or to undergo chemical change in the body, except if the devices are placed in the teeth,
or to administer medicines, in which case they are in Class IIb.
2.4. Rule 8
All implantable devices and long..term surgically invasive devices are in Class IIb unless they are intended:
- to be placed in the teeth, in which case they are in Class IIa,
- to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,
- to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,
- or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III.
3. Additional rules applicable to active devices
3.1. Rule 9
All active therapeutic devices intended to administer or exchange energy are in Class IIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are in Class IIb.
All active devices intended to control or monitor the performance of active therapeutic devices in Class IIb, or intended directly to influence the performance of such devices are in Class IIb.
3.2. Rule 10
Active devices intended for diagnosis are in Class IIa:
- if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum,
- if they are intended to image in vivo distribution of radiopharmaceuticals,
- if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which case they are in Class IIb.
Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class IIb.
All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner:
- that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.
3.3. Rule 12
All other active devices are in Class I.
4. Special Rules 4.1. Rule 13
All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 65j65jEEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III.
4.2. Rule 14
All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class lIb, unless they are implantable or long term invasive devices, in which case they are in Class III.
4.3. Rule 15
All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class lIb.
All devices intended specifically to be used for disinfecting medical devices are in Class IIa.
This rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.
4.4. Rule 16
Non-active devices specifically intended for recording of X-ray diagnostic images are in Class IIa.
4.5. Rule 17
All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class III except where such devices are intended to come into contact with intact skin only.
5. Rule 18
By derogation from other rules, blood bags are in Class lIb.
CLINICAL EVALUATION 1. General provisions
1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I under the normal conditions of use of the device and the evaluation of the undesirable side-effects must be based on clinical data in particular in the case of implantable devices and devices in Class III. Taking account of any relevant harmonized standards, where appropriate, the adequacy of the clinical data must be based on:
1.1.1. either a compilation of the relevant scientific literature currently available on the intended purpose of the device and the techniques employed as well as, if appropriate, a written report containing a critical evaluation of this compilation;
1.1.2. or the results of all the clinical investigations made, including those carried out in conformity with Section 2.
1.2. All the data must remain confidential, in accordance with the provisions of Article 20.
2. Clinical investigations
The objectives of clinical investigation are:
- to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and
- to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.
2.2. Ethical considerations
Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the 41st World Medical Assembly in Hong Kong in 1989. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.
2.3.1. Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer's claims for the device; these investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions.
2.3.2. The procedures used to perform the investigations must be appropriate to the device under examination.
2.3.3. Clinical investigations must be performed in circumstances similar to the normal conditions of use of the device.
2.3.4. All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined.
2.3.5. All adverse incidents such as those speCified in Article 10 must be fully recorded and notified to the competent authority.
2.3.6. The investigations must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment.
The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device.
2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation.
CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIED BODIES 1. The notified body, its Director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
2. The notified body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.
Should the notified body subcontract specific tasks connected with the establishment and verification of the facts, it must first ensure that the subcontractor meets the provisions of the Directive and, in particular, of this Annex. 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.
3. The notified body must be able to carry out all the tasks assigned to such bodies by one of Annexes II to VI and for which it has been notified, whether these tasks are carried out by the body itself or on its responsibility. In particular, it must have the necessary staff and possess the facilities needed to perform properly the technical and administrative tasks entailed in assessment and verification. It must also have access to the equipment necessary for the verifications required.
4. The notified body must have:
- sound vocational training covering all the assessment and verification operations for which the body has been designated,
- satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections,
- the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.
5. The impartiality of the notified body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.
6. The body must take out civil liability insurance, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.
7. The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-a-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to this Directive or any provision of national law putting it into effect.
CE MARKING OF CON FORMI1Y The CE conformity marking shall consist of the initials 'CE' taking the following form:
- If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
- The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
This minimum dimension may be waived for small-scale devices.
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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
OJ L 169, 12.71993, p. 1-43 (E~ DA, D~ EL, E~ FR, 17; N( PT) Finnish special edition: Chapter 13 Volume 24 P. 0085 Swedish special edition: Chapter 13 Volume 24 P. 0085 Special edition in Czech Chapter 13 Volume 012 P. 82 - 124 Special edition in Estonian Chapter 13 Volume 012 P. 82 - 124 Special edition in Hungarian Chapter 13 Volume 012 P. 82 - 124 Special edition in Lithuanian Chapter 13 Volume 012 P. 82 - 124 Special edition in Latvian Chapter 13 Volume 012 P. 82 - 124 Special edition in Maltese Chapter 13 Volume 012 P. 82 - 124 Special edition in Polish Chapter 13 Volume 012 P. 82 - 124 Special edition in Slovakian Chapter 13 Volume 012 P. 82 - 124 Special edition in Slovenian Chapter 13 Volume 012 P. 82 - 124
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I> The official languages, Icelandic, Norwegian Dates
of document: 14/06/1993 of notification: 00/00/0000 of effect: 00/00/0000; Entry into force Date !lotif.
end of validity: 31/12/2008; See 31984L0539 of transposition: 01/07/1994; At the latest Adoption See Art 22 of transposition: 01/01/1995; Application See Art 22
1>. EUROVOC descriptor:
medical and surgical instruments harmonisation of standards radiobiology public health occupational safety radiation protection
I> Directory code:
13.30.99.00 Industrial policy and internal market / Internal market: approximation