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An outline of the CE marking procedure
An outline
of the CE marking
procedure C Schoenmakers
(Received
he transitional period for the Medical Devices Directive 93/42/EEC (MDD) [l] is due to come to an end on 14 June 1998. Thereafter all medical devices sold and used within the European Union must comply with the requirements set out in the said directive and must also be provided with the CE marking. The transitional period for the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) [2] expired in 1995. The many questions of manufacturers and traders of how to proceed with regard to these directives have led us to draw up a clear description of the entire CE conformity assessment procedures. This paper gives a short overview of these procedures.
The CE marking procedure The procedure begins with the question as to which directive applies to the product in question. Once it is established that a certain product qualifies as a medical device (product identification), the product is then classified. (No such classification procedure applies in the case of the AIMDD). A conformity assessment procedure is then set up for each class. These assessment procedures prescribe certain formalities, and if the device complies with all of the stipulations set out in the directives, the CE marking can then be applied. Class I devices must be registered with the
SWBC Amsterdam. Netherlands.
Technical
& Legal Advisors,
Amsterdamseweg
RBM
498, Amstelveen,
1998 ; 20 : 58-60 0 Elsevier,
Paris
13/03/98;revised
15/04/98;accepted
18/04/98)
Competent Authority of the Member State where the device is put on the market. n Product
identification
During the phase of product identification one seeks to establish which of the directives applies to the product in question. In the case of the MDD two factors play a part. The product must be a medical device in the sense set out in the directive and must also be intended to be used as such by the manufacturer. The New Approach directives - and thus also the directives which apply to medical devices are formulated in a very general way. As a result, the sphere of application is extremely broad, to the point that it is sometimes difficult to determine a limit. Although an electric toothbrush is effectively used to prevent disease, in this case dental cavities, the directive sees this as a toiletry article. Instruments used to apply tattoos include needles that pierce the skin. However, in this case the function is cosmetic, and the same applies to the camouflage of birthmarks, etc. In a certain sense the auditory signal at a pedestrian crossing serves to alleviate or compensate for a handicap for the partially sighted but the device does not come under the directive. In this case there must be a direct link between the patient and the device. When it comes to active implantable devices, the situation is
postbus
2091,
1180 EB Amstelveen,
The
CE marking
somewhat simpler. Again, in this case the device must comply with the definition set out in the directive, and the requirement regarding the intended use also applies. However, the exceptions are limited. The device must be active, in other words the device must be activated by some source of electrical energy or a source of energy other than that generated by the human body or by gravity. In addition to this, the device must also be implantable, in other words it must be designed to be entirely or partially implanted in its operative mode in the human body and to stay there. n Product
classification
According to the MDD, products are divided into four different classes: classes I, IIa, IIb and III. Products are classified on the basis of 18 classification rules. The answers to the following questions play a part in determining the final classification: is the device intended to be used on a temporary, short-term or long-term basis?; Is the device invasive or non-invasive (this may or may not require a surgical procedure)?; Is the device an implantable device?; Can the product be defined as reusable surgical material?; Is the device an active medical device?; Is the device an active therapeutic device?; Is the device an instrument used for diagnosis?; Does the device come into contact with any of the vital organs? A number of product groups are excluded from this classification. These include custom-made devices, devices used to carry out clinical examination and systems and treatment kits. The first two groups are not provided with the CE marking. W The conformity procedure
assessment
Depending on the class to which the device is assigned, there then follows a certain procedure with associated formalities. For most classes there are a number of procedures with the choice being left relatively open. These procedures are described in Appendices II-VII to the MDD and Appendices II-VI to the AIMDD.
of medical
devices
The simplest procedure is described in Appendix VII to the MDD. This Appendix applies to the products in class I. The procedure in question includes such elements as the essential safety requirements, European harmonised standards, the risk analysis, the technical documentation, the setting up of a systematic procedure and the Declaration of Conformity. In principle, the manufacturer can complete this procedure independently, in which case the product is said to be self certified. When it comes to the devices in classes IIa, IIb, and III and the active implantable devices, the formalities are more extensive. A type examination may be required to show that a selected device is representative of the whole production run. Naturally, this is particularly important in the case of mass produced devices. Furthermore, quality systems which apply not only to the product but also to the production process may also be required. In the case of sterile devices it is not so much imperative to know whether the product subject to inspection was sterile, the company in question must be able to show that the production process is of such a quality that the possibility of there being a non-sterile product falls below a certain value. A notified body must be appointed for all of these devices. The essential requirements and harmonised standards Appendices I to the MDD and the AIMDD list the essential safety requirements with which medical devices must comply. Roughly speaking, there exist three different groups of requirements: general requirements, requirements pertaining to the design and construction, and requirements pertaining to the information to be supplied by the manufacturer. Most of these requirements are formulated in a very general way and give little indication as to how the manufacturer can comply with these requirements in practice. European harmonised standards are far more practical for the manufacturer since these standards also describe test procedures and limit values. RBM
1998 ; 20 : 58-60
The risk analysis The risk analysis is a compulsory element of all procedures. A special standard has been drawn up to cover this point: EN 1441 Medical Devices: Risk Analysis. This is a helpful instrument when establishing and assessing the risks related to a medical device. Think, for example, of the dangers related to (incorrect) use, malfunction, the energy transmitted via the device, toxicity, infection, etc. The Technical File
Documentation
The Technical Documentation File must make it possible for an inspectorate to assess whether the device conforms to the stipulations set out in the directive. For this reason the Technical Documentation File must include at least the following components: an extensive description of the product, technical drawings, the production techniques, design calculations, the results of the risk analysis, the results of the inspections carried out, labelling, and the directions for use. If applicable, the dossier should also include information about the sterilisation process used, clinical data and any other similar data. The dossier must be written in the language of the Member State in question or in one of the other languages of the Community. The Declaration of Conformity and the application of the CE Marking The CE Marking consists of the letters CE which are marked on the device in question, or if this is not possible on account of the size or function of the device on the accompanying instructions for use and/or on the packaging. However, the marking does not give a clear indication of which of the directives the product complies with. In the Declaration of Conformity the manufacturer (or the manufacturer’s authorised representative established within the Community) declares that the device in question complies
C Schoenmakers
with all of the requirements out in the directive. Registration authority
with
set
a competent
Before the device can be put onto the market the persons responsible, these being the manufacturer or the manufacturer’s authorised representative established within the Community, must register with the Competent Authority of the Member State in question. Class I devices must also be registered with the said Competent Authority. Furthermore, any incidents which may occur after the device has been put onto the market must be reported to the same Competent Authority.
Conclusion This paper is meant outline the procedure
to briefly to be fol-
lowed for the CE marking of medical devices. It would be too involved to include a discussion of all of the exceptions and special cases here. n
REFERENCES 1 European Economic Community. Council Directive of20 ]une 1990 on the approximation of the laws of the Member States relating to active implantable medical devices 90/385/EEC. Brussels: EEC; 1992 2 European Economic Community. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Brussels: EEC; 1993 3 Schoenmakers CCW. CE Marking for Medical Devices. IEEE Press; 1997 4 Veldkamp M. CE Marking, the new legislation for products. SWBC Organization for the European Conformity of Products; 1996
RBM
1998 ; 20 : 58-60
of the CE marking
procedure C Schoenmakers
(Received
he transitional period for the Medical Devices Directive 93/42/EEC (MDD) [l] is due to come to an end on 14 June 1998. Thereafter all medical devices sold and used within the European Union must comply with the requirements set out in the said directive and must also be provided with the CE marking. The transitional period for the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) [2] expired in 1995. The many questions of manufacturers and traders of how to proceed with regard to these directives have led us to draw up a clear description of the entire CE conformity assessment procedures. This paper gives a short overview of these procedures.
The CE marking procedure The procedure begins with the question as to which directive applies to the product in question. Once it is established that a certain product qualifies as a medical device (product identification), the product is then classified. (No such classification procedure applies in the case of the AIMDD). A conformity assessment procedure is then set up for each class. These assessment procedures prescribe certain formalities, and if the device complies with all of the stipulations set out in the directives, the CE marking can then be applied. Class I devices must be registered with the
SWBC Amsterdam. Netherlands.
Technical
& Legal Advisors,
Amsterdamseweg
RBM
498, Amstelveen,
1998 ; 20 : 58-60 0 Elsevier,
Paris
13/03/98;revised
15/04/98;accepted
18/04/98)
Competent Authority of the Member State where the device is put on the market. n Product
identification
During the phase of product identification one seeks to establish which of the directives applies to the product in question. In the case of the MDD two factors play a part. The product must be a medical device in the sense set out in the directive and must also be intended to be used as such by the manufacturer. The New Approach directives - and thus also the directives which apply to medical devices are formulated in a very general way. As a result, the sphere of application is extremely broad, to the point that it is sometimes difficult to determine a limit. Although an electric toothbrush is effectively used to prevent disease, in this case dental cavities, the directive sees this as a toiletry article. Instruments used to apply tattoos include needles that pierce the skin. However, in this case the function is cosmetic, and the same applies to the camouflage of birthmarks, etc. In a certain sense the auditory signal at a pedestrian crossing serves to alleviate or compensate for a handicap for the partially sighted but the device does not come under the directive. In this case there must be a direct link between the patient and the device. When it comes to active implantable devices, the situation is
postbus
2091,
1180 EB Amstelveen,
The
CE marking
somewhat simpler. Again, in this case the device must comply with the definition set out in the directive, and the requirement regarding the intended use also applies. However, the exceptions are limited. The device must be active, in other words the device must be activated by some source of electrical energy or a source of energy other than that generated by the human body or by gravity. In addition to this, the device must also be implantable, in other words it must be designed to be entirely or partially implanted in its operative mode in the human body and to stay there. n Product
classification
According to the MDD, products are divided into four different classes: classes I, IIa, IIb and III. Products are classified on the basis of 18 classification rules. The answers to the following questions play a part in determining the final classification: is the device intended to be used on a temporary, short-term or long-term basis?; Is the device invasive or non-invasive (this may or may not require a surgical procedure)?; Is the device an implantable device?; Can the product be defined as reusable surgical material?; Is the device an active medical device?; Is the device an active therapeutic device?; Is the device an instrument used for diagnosis?; Does the device come into contact with any of the vital organs? A number of product groups are excluded from this classification. These include custom-made devices, devices used to carry out clinical examination and systems and treatment kits. The first two groups are not provided with the CE marking. W The conformity procedure
assessment
Depending on the class to which the device is assigned, there then follows a certain procedure with associated formalities. For most classes there are a number of procedures with the choice being left relatively open. These procedures are described in Appendices II-VII to the MDD and Appendices II-VI to the AIMDD.
of medical
devices
The simplest procedure is described in Appendix VII to the MDD. This Appendix applies to the products in class I. The procedure in question includes such elements as the essential safety requirements, European harmonised standards, the risk analysis, the technical documentation, the setting up of a systematic procedure and the Declaration of Conformity. In principle, the manufacturer can complete this procedure independently, in which case the product is said to be self certified. When it comes to the devices in classes IIa, IIb, and III and the active implantable devices, the formalities are more extensive. A type examination may be required to show that a selected device is representative of the whole production run. Naturally, this is particularly important in the case of mass produced devices. Furthermore, quality systems which apply not only to the product but also to the production process may also be required. In the case of sterile devices it is not so much imperative to know whether the product subject to inspection was sterile, the company in question must be able to show that the production process is of such a quality that the possibility of there being a non-sterile product falls below a certain value. A notified body must be appointed for all of these devices. The essential requirements and harmonised standards Appendices I to the MDD and the AIMDD list the essential safety requirements with which medical devices must comply. Roughly speaking, there exist three different groups of requirements: general requirements, requirements pertaining to the design and construction, and requirements pertaining to the information to be supplied by the manufacturer. Most of these requirements are formulated in a very general way and give little indication as to how the manufacturer can comply with these requirements in practice. European harmonised standards are far more practical for the manufacturer since these standards also describe test procedures and limit values. RBM
1998 ; 20 : 58-60
The risk analysis The risk analysis is a compulsory element of all procedures. A special standard has been drawn up to cover this point: EN 1441 Medical Devices: Risk Analysis. This is a helpful instrument when establishing and assessing the risks related to a medical device. Think, for example, of the dangers related to (incorrect) use, malfunction, the energy transmitted via the device, toxicity, infection, etc. The Technical File
Documentation
The Technical Documentation File must make it possible for an inspectorate to assess whether the device conforms to the stipulations set out in the directive. For this reason the Technical Documentation File must include at least the following components: an extensive description of the product, technical drawings, the production techniques, design calculations, the results of the risk analysis, the results of the inspections carried out, labelling, and the directions for use. If applicable, the dossier should also include information about the sterilisation process used, clinical data and any other similar data. The dossier must be written in the language of the Member State in question or in one of the other languages of the Community. The Declaration of Conformity and the application of the CE Marking The CE Marking consists of the letters CE which are marked on the device in question, or if this is not possible on account of the size or function of the device on the accompanying instructions for use and/or on the packaging. However, the marking does not give a clear indication of which of the directives the product complies with. In the Declaration of Conformity the manufacturer (or the manufacturer’s authorised representative established within the Community) declares that the device in question complies
C Schoenmakers
with all of the requirements out in the directive. Registration authority
with
set
a competent
Before the device can be put onto the market the persons responsible, these being the manufacturer or the manufacturer’s authorised representative established within the Community, must register with the Competent Authority of the Member State in question. Class I devices must also be registered with the said Competent Authority. Furthermore, any incidents which may occur after the device has been put onto the market must be reported to the same Competent Authority.
Conclusion This paper is meant outline the procedure
to briefly to be fol-
lowed for the CE marking of medical devices. It would be too involved to include a discussion of all of the exceptions and special cases here. n
REFERENCES 1 European Economic Community. Council Directive of20 ]une 1990 on the approximation of the laws of the Member States relating to active implantable medical devices 90/385/EEC. Brussels: EEC; 1992 2 European Economic Community. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Brussels: EEC; 1993 3 Schoenmakers CCW. CE Marking for Medical Devices. IEEE Press; 1997 4 Veldkamp M. CE Marking, the new legislation for products. SWBC Organization for the European Conformity of Products; 1996
RBM
1998 ; 20 : 58-60