Journal of Tissue Viability 1999 Vol 9 No 1 11

CE marking- what does it really mean?

Dave Bentley

Group Regulatory Manager, Huntleigh Technology PLC

Compliance with the Medical Devices Directive (93/42/EEC) became compulsory for all medical devices placed on the European market in June 1998. Under the directive, manufacturers are required to fulfil a number of require­ments leading to the placing of the CE mark on their devices. However, many questions still remain. Not all manu­facturers are aware of their responsibilities and not all purchasers are aware of the true meaning of the CE mark. It is vital to understand the purpose of the regulations, the definition of 'medical device', the importance of comply­ing with the manufacturer's intended purpose and instructions, the role of quality systems and clinical investigations in the compliance process, and the decisions which may be made by the manufacturer. It is also important to realise that whilst the directive, if correctly applied and enforced, brings benefits to the medical industry and patients, it is not a substitute for professional judgement in the purchasing process.

Introduction The Medical Devices Directive (MDD) and (more gener­ally) CE marking is beginning to bring the world of regula­tory affairs to the attention of the real world! As the Medical Devices Agency (MDA) 1, purchasing authorities2 and medical device manufacturers spread their message or messages to the world, a short explanation of the reality may help.

Manufacturers, suppliers, and, to a certain extent, regulatory authorities, have put a great deal of work into complying with the new rules. Although CE marking to the MDD is not the global panacea that some may claim, it should, and if properly enforced will, provide reassurance to the customers of responsible medical device manufacturers.

Whether you are manufacturing, selling or purchasing, it is important to understand the origin of the regulations, and the guarantees provided by compliance.

New approach directives The MDD3 is one of a group of European directives termed 'New Approach'. These directives, which are required, by law, to be implemented in each of the member states of the European Union, are intended to remove barriers to trade. It is important to understand the thought processes behind the directives in order to appreciate some of the decisions that have been and will be made.

When the decision to remove internal barriers was suggested, there was considerable discussion about the rela­tive safety and quality of products from different parts of Europe. The answer to these problems was to provide a basic minimum level of safety which could be applied across the EU.

In 'New Approach' directives, this minimum level is speci­fied in the Essential Requirements, and is normally Annex I of each directive. In some directives, the requirements are fairly simple (and short); in others, such as the MDD, they are more complex. Compliance with relevant harmonized European Standards gives a presumption of conformity with the Essential Requirements4 (see below). The direc­tives also specify procedures to assess compliance (gener­ally involving product testing and/or quality assurance requirements) based on the level of risk for that product group5.

TheCEmark The other notable aspect of all 'New Approach' directives is that demonstration of conformity involves placing of a CE mark on the product. Apart from some subtle differ­ences, one CE mark looks very much like another. For full details of compliance, reference to the declaration of conformity, which always precedes a CE mark, is required. The declaration will refer, amongst other things, to the directive or directives to which compliance is being claimed6.

Received 15 August 1998; revised 10 September 1998; accepted 8 October 1998 © Tissue Viability Society

12 Journal of Tissue Viability 1999 Vol 9 No 1

MEDICAL DEVICE

'Article, ... alone or in combination, including the software' 'Intend by the manufacturer to be used for human beings for ... • diagnosis, prevention, monitoring, treatment or alleviation of

disease, injury or handicap? • compensation for injury or handicap • Investigation, replacement or modification of the anatomy or

of a physiological process • control of conception'

ACCESSORY

'Intended by the manufacturer to be used with a device to enable it to perform its intended function'

Figure 1 Definition of a medical device3

Scope of the Medical Devices Directive Is a surgeon's glove a medical device, or personal protective equipment? Is a short flat wooden stick a medical device or a toy ... or even just part of a lollipop? By comparing defi­nitions from a range of directives (Figure 1), manufacturers have to sort out such earth-shattering problems. Often, these are just amusing to regulatory affairs managers (Does a ramp compensate for not being able to get up steps? Is preg­nancy an injury or handicap?), but sometimes they have substantial commercial effects on manufacturers by intro­ducing a slope to our playing field.

For example, being used in a hospital does not tum a bed into a medical device. We have to look at the intended performance of the equipment. The advertised ability to achieve the Trendelenburg position is involved in the treat­ment of disease and makes the product a medical device. In addition, the design of hospital beds to accept such items as fracture frames and intravenous drip poles is arguably intending them to be used in combination, to treat, alleviate etc.

Generally, hospital mattresses do not carry any claims of a medical nature. There has been a lot of discussion over whether a standard hospital mattress is an accessory, and hence under the scope of the MDD. Since it is 'to be used with a device (the hospital bed) to enable it to perform its intended function', it would appear to be within the scope. However, the opinion of the MDA (personal communica­tion), that a standard hospital mattress is not an accessory, and neither is a bed side rail, since they do not themselves have a medical function, is an interesting interpretation of the English language. It should be noted that anti-decubitus mattresses are clearly medical devices, and are therefore subject to this increased regulatory regime. It's all about the claims made for the product.

If a walking stick is used for people who are old, lazy or Charlie Chaplin impersonators, it is not a medical device. If, however, it is specifically intended by the manufacturer to compensate for an injury or handicap, it becomes a medical device.

Timing All 'New Approach' directives incorporate a transitiOn period. This is to allow all parties to prepare themselves mentally and physically for the change. During this time, manufacturers can choose to apply either the individual country rules which previously existed, or the new directive requirements. After the transition period, the directive is compulsory. The transition period for the MDD ended on 14 June 1998.

It should be noted that there has been much discussion concerning the definition of 'placing on the market and putting into service' (the point at which the regulations apply). The European Commission Guidelines7 say that if a non-CE marked product was in the supply chain before 13 June 1998 it can be first put into service at any time until 2001. Not all member states agree.

Criminal law Offences under the implementations of the MDD in member states are punishable by fines and imprisonment. Most of the obligations referred to below are obligations on the 'manufac­turer'. However, the manufacturer is not necessarily the person who makes the device (Figure 2). The definition of manufac­turer appears to be a fairly obvious and correct description of the right person to blame for any problems, but it needs to be considered in relation to the real world. Consider:

• pressure-reducing cushions used under the patient's heels, i.e. outside their intended purpose

• replacement of the deck material on a hospital bed with­out reference to the original 'manufacturer' in order to improve drainage/airflow, i.e. a new intended purpose, and possibly a change in mechanical properties

• use of a pump and mattress combination (or hoist and sling combination) which was not 'intended' by the orig­inal manufacturer

In all three cases, my advice is to check with the original equipment manufacturer. If you take the product(s) outside of the original intended purpose you could be the 'manufac­turer'. Your lawyers and insurers are likely to have a view on this.

Whilst for in-house (hospital-based) manufacture, the MDA will only impose the MDD if those items are transferred to other hospitals (placed on the market)8, they expect hospi­tals to follow levels of control similar to the MDD in order to satisfy their legal obligations when manufacturing items for internal hospital use.

MANUFACTURER

The one who ... 'assembles, packages, processes, fully refurbishes and/or labels ... or assigns their intended purpose ... placed on the market under his own name'

Figure 2 Definition of manufacturer3

The basic directive requirements Whether you're a manufacturer yourself, or merely prepar­ing to question manufacturers about their compliance, the following information is important.

The general principle of the directive is that all medical devices should meet some basic requirements, and that, depending on the type of device, compliance with these requirements should be demonstrated by using one of vari­ous compliance routes.

For all devices, the manufacturer must hold the relevant 'technical documentation' showing conformance with the requirements, and operate the conformity assessment proce­dures dictated by the class of product. Once these two tasks have been performed, the declaration of conformity can be made and the CE mark placed on the product (Figure 3).

Classification The process of classification involves using the rules speci­fied in Annex IX of the directive. There are four classes of product - I, Ila, lib and III - with class I being low-risk devices and class III high-risk devices requiring the greatest involvement (eg quality system assessment, product evalua­tion) from independent third parties, known as 'Notified Bodies'. The rules which place devices into the different classes include whether they are diagnostic, therapeutic, invasive, administering energy etc. Pressure-reducing mattresses, alternating-pressure mattresses, hoists, bath­lifters, hospital beds, trolleys, stretchers, pressure-reducing seating cushions and couches are generally considered to be class I, whereas traction machines, ultrasonic Doppler fetal and vascular flow monitors and intermittent compression devices are class Ila. It is the administration of energy to the body which places them in class Ila.

Classification is not a straightforward issue, and there have already been sets of Commission Guidelines (which were not necessarily very helpful) in an attempt to produce the desired level playing field. Much like whether a product is a medical device, its classification relates to the intended use. Claims of control of the patient micro-environment, for example, could in certain circumstances raise a product to class Ila.

Conformity assessment route As we have already mentioned, the classification of the device governs the conformity assessment route which needs to be followed. These routes include quality system and product approvals options, the most common of which are noted here.

For class I products (excluding those supplied sterile or which have a measuring function), the only legal require­ment is for the manufacturer to register with the MDA, and to self-declare compliance. No Notified Body involvement is required. However, it is difficult to see how a manufac­turer can ensure that all products meet the specification in the technical documentation (see below) without operating some kind of quality system.

Journal of Tissue Viability 1999 Vol 9 No 1 13

Is it a medical device?

I I I

Design to Classify product meet requirements of

Annex I

I & I Choose and Compile and

follow conformity hold technical assessment route documentation

I I I I

Make declaration of conformity

I CE mark

Figure 3 Manufacturers' responsibilities

For class Ila and above, some Notified Body involvement is necessary. There are options of quality system and product testing which the manufacturer can elect to have certified by a Notified Body. The most commonly used quality standards include:

• IS09001, EN46001 and Annex II, referring to full qual­ity systems

• IS09002, EN46002 and Annex V, referring to production quality systems

• IS09003, EN46003 and Annex VI (rarely used), referring to end-of-line testing

Some verification by an independent body is required for all higher-risk products (classes Ila, lib, III). The identity of the Notified Body involved is indicated by a four-digit number accompanying the CE mark. The higher the class, the higher the involvement.

Technical documentation Whatever conformity assessment route is chosen, manufac­turers are required to demonstrate compliance with the requirements for all medical devices. This information is controlled, and available for inspection by the relevant authorities, in the technical file. Typically a technical file will contain:

• a description of the product and reference to full details of how to make it (drawings, bills of material, build instructions etc)

• a risk assessment • a checklist of how the manufacturer has ensured that all

the essential requirements are met • the product labels, user manual, training manual, adver­

tising and sales literature, which form the product claims that have to be justified

• supporting data for the risk analysis and essential require­ment checklist, including clinical papers, user evaluation

14 Journal of Tissue Viability 1999 Vol 9 No 1

results, safety test results, electromagnetic compatibility reports, flammability test results etc.

• justification of the classification decision (which, for class Ila and above, is agreed with the Notified Body)

Probably the most important part of the technical file is the risk analysis. This is normally performed by a team of people from within the manufacturing organization and/or external parties where further specialist knowledge is required (eg infection control). The process of risk analysis 'Would generally follow EN14419, and basically includes the following steps.

• Identification of characteristics which might affect the safety of the product. This will include all aspects of design, use and reasonable abuse.

• Identification of possible hazards associated with each characteristic. For existing products, much of this comes from experience and the rest from educated guessing of what may happen.

• Assessment of the level of risk for each hazard. This is a combination of how likely the event is to occur and how serious the harm may be if it does occur.

• Decision on acceptability. This last step is the most important. Since no product is totally safe, a decision is made on which level of safety is acceptable, bearing in mind the benefits to the patient.

Taking as an example the incident of a patient smoking on a pressure-reducing mattress, one possible hazard is that the patient is injured by a fire caused by dropping a cigarette or match. In establishing the risk associated with this hazard we need to consider the smoking policy in the establishment concerned, the flammability levels of materials used in the mattress, the presence of other materials on the mattress (sheets, pillows, clothes), the cognitive ability of the patient, the mobility of the patient, the presence of trained or untrained carers, historical incidents etc.

The manufacturer is required, when reducing risks to an acceptable level, to first try to design out the problem, second guard against it, and third warn about it. When making decisions about which of these are possible, the patient benefits are important. Material choice depends on a number of factors of different importance levels. Flammability is just one of these; the main purpose of the mattress is to prevent pressure sores. Finally, we decide whether the achieved level of safety is acceptable. All the above information is combined with some type of testing to a recognized standard, and possibly a warning, to give an acceptable level.

The same principle of risk assessment is applied to electri­cal safety, biocompatibility, infection control etc.

Essential requirements In addition to the risk analysis, we are required to demon­strate compliance with the essential requirements. In prac­tice, the end results in terms of testing and evaluation are the same as those from the risk analysis, but this does act as a

useful reminder of areas for consideration, and adds a requirement for proof of clinical/medical claims.

The simplest way to satisfy this requirement is to construct a table listing the requirement and the methods used to comply with it. Generally, harmonized European standards or international standards will be used if available. It is worth noting three important points.

• There are no compulsory standards. Manufacturers can choose which standards they feel are most appropriate.

• If the manufacturer chooses a harmonized European stan­dard, he has a presumption of conformity with the requirements that it covers.

• The policy of many customers to ask which standards a product complies with could in theory result in a very detailed and convoluted explanation which is technically correct and practically sensible, but which may not be readily understood.

There is not always a suitable standard available, and often there does not need to be. In these circumstances, we would use alternative methods to show compliance.

The clinical claims for an alternating-pressure mattress, for example, may be supported by a combination of relevant clinical papers and laboratory tests, possibly including inter­face pressure measurements. A full EN54010 clinical inves­tigation is not performed if it is not required. The MDA have issued guidance11 which states that 'Only in a minority of cases will a specifically designed clinical investigation be necessary in order to demonstrate device safety and perfor­mance as required by the directive'. Hence the CE mark is neither proof nor guarantee that a sophisticated clinical investigation underpins performance claims.

The MDA interpretation of the MDD requirements, shown above, relates to Annex X of the directive. This annex describes the procedure that must be followed to establish clinical safety and performance. Basically, if the essential requirements cannot be met using historical data, scientific data and other previously published material, the informa­tion needs to be established via an EN540 clinical investiga­tion, approved by the MDA.

Declaration of conformity In order to declare that the relevant compliance route and technical documentation have been adequately completed, the manufacturer must make a declaration of conformity to the directive. This is normally a single sheet bearing the signature of the managing director or equivalent. The newly CE-marked product can now be legally placed on the European market.

Post-marketing requirements The directive's requirements do not end with the CE mark. Manufacturers are required to adopt a vigilance procedure, which reviews experience and information from the field,

and to report any adverse incidents (which led to or may have led to death or serious injury) to the relevant competent authority. It is as a result of such an incident that the pre-CE mark work is most likely to be called into question.

Conclusion The manufacturer's responsibilities under the Medical Devices Directive are many. Correct and responsible use of the regulations will enable them to produce a safe and effec­tive product. However, products from different manufactur­ers are likely to be of different qualities, to claim different levels of performance, and to have different levels of supporting data. It is important to understand the claims being made, to work within the performance limits defined by the manufacturer, and to continue to use professional judgement in the purchasing decision.

Address for correspondence D Bentley, Huntleigh Technology PLC, 310-312 Dallow Road, Luton, Bedfordshire, LU1 lTD, UK. Tel: 01582 745751.

References Medical Devices Agency, British Standards Institution and Association of British Health Care Industries. Products You Can Have Confidence In: MDA/CE/Revision 2. December 1997.

2 Pre-Purchase Questionnaire: Form PPQ 1198. NHS Supplies,

Journal of Tissue Viability 1999 Vol 9 No 1 15

Scottish Healthcare Supplies, Northern Ireland Central Services Agency, Welsh Health Supplies, Association of British Healthcare Industries.

3 Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. Council of the European Communities, 1993.

4 Article 5. In: Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. Council of the European Communities, 1993.

5 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE confor­mity marking, which are intended to be used in the technical harmonization directives.

6 Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electro­magnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

7 Final Draft Communication of the Commission on the Application of the Transitional Provisions of Directive 93/42/EEC Relating to Medical Devices. European Commission DGIII, 5 June 1998.

8 Medical Devices Agency. Activities of healthcare establishments (in house manufacture) in the UK. Directives Bulletin 1996; 18A.

9 EN 1441: 1997. Medical Devices; Risk Analysis. October 1997. 10 EN540: 1993. Clinical Investigation of Medical Devices for

Human Subjects. June 1993. 11 Guidance Notes for Manufacturers of Class I Medical Devices.

Medical Devices Agency.