A Comparative Analysis of Medical Device Regulations in the EU and the USA

Bachelor Thesis, 2012

74 Pages, Grade: First



List of Figures

List of Tables

List of Abbreviations

1. Introduction
1.1 Research Question
1.2 Plan of Research

2. Economics of Health Care
2.1 Principles of Economics
2.2 Regulating Markets

3. European Medical Device Regulations
3.1 General Regulatory Framework
3.2 Conformity Assessment Procedure
3.3 Placing Products on the Market
3.4 Case Study - Poly Implant Prothèse

4. Medical Device Regulations in the United States
4.1 Analysis of current Regulatory Framework
4.2 Premarketing Requirements
4.3 Device Production and Quality Management
4.4 Case Study - Medtronic Infuse Bone Graft

5. Conclusion and Recommendations
5.1 Comparison
5.2 Recommendation
5.3 Critical Acclaim
5.4 Outlook and Forecast

Publication Bibliography

Appendix I

Appendix II

List of Figures

Figure 1: Figure 1: Plan of Research

Figure 2: The Circular Flow

Figure 3: Four Types of Goods

Figure 4: Flow Chart adjusted for the Medical device market

Figure 5: Path of Conformity Assessment

Figure 6 Stages of clinical evaluation

Figure 7: Overview of Medical Device Control Steps

List of Tables

Table 1: Top 10 countries by sales revenue 2009

Table 2: European medical device classification

Table 3: Recommendations for the EU framework

Table 4: Recommendations for the U.S. framework

Table 5: Comparison of the EU and the U.S. framework

Table 6: Recommendations for the European regulation system

Table 7: Recommendations for the U.S. regulation system

List of Abbreviations

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1. Introduction

1.1 Research Question

Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU).

Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001).

Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.

In 2009, José Manuel Barroso, President of the European Commission, said:

“Smart regulation should protect the consumer; deliver effectively on public policy objectives without strangling economic operators…” (Eucomed 2011).

According to the World Health Organization (WHO), 65% of all countries have an authority responsible for implementing and enforcing medical device specific product regulations (Banta, p. 18).

The main reason for comparing the U.S. and European regulatory systems is the importance of these markets for the global medical device industry. Nineteen of the largest thirty medical device manufacturers are headquartered in the U.S. and nine in Europe. Together these companies are accountable for 86% of the global sales revenue, leaving 14% for the remaining of the approximately 27,000 manufacturers (Banta, p. 15). Regarding the sales revenue (Table 1) the U.S. market counts for 40.7% and the European countries listed for 22.9% which underlines the importance of these two single markets.

Table 1: Top 10 countries by Sales Revenue, 2009 (Banta, p.15)

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Recent events brought European medical device regulations into the public focus when news broke that the French breast implant company Poly Implant Prothèse (PIP) used unapproved industrial-grade silicone in their products that were implanted approximately 400,000 times worldwide. Breast implants are regulated as Class III products in Europe and are therefore subject to the strictest pre-market controls. The fact that PIP managed to circumvent regulatory oversight in the post-market phase unsettled trust in the regulatory system (United Kingdom Department of Health 2012, p. 18). Likewise, the U.S. has had its own recent challenges with its medical device regulatory system. Medtronic Inc. got his Infuse Bone Graft approved in 2002 which enables bone growth by incorporating a synthetic recreation of the protein naturally responsible for that. The product got approved only for three special types of surgery; however it is estimated that it has been used in ways not approved by the FDA in 85% of the cases. As long as doctors see a benefit in using a device a certain way they are free to use an approved product anyway they want but manufacturers are not allowed to promote any different use that the intended one. Infuse patients experienced uncontrolled bone growth after the surgery which resulted in permanent injuries or death (Harris 2012).

1.2 Plan of Research

The main objective of this study is to provide a descriptive analysis of the regulatory framework in the two markets, to identify the failures and successes of each and to make recommendations for improvement. The U.S. and European Union have well-established regulatory systems which vary in some significant aspects. While the U.S. Congress established a government authority in the Food and Drug Administration (FDA) to oversee medical devices, the European system does not actively involve a governmental agency and its approach is more towards de-regulation and self-control by manufacturers. The comparison of the systems concludes in the determination of a new set of regulations that maximizes the benefits for all stakeholders.

After the introduction the second chapter will focus on principles and economics, reasons for market failures and will give an explanation why governmental regulation is needed in the field of health care, especially medical devices. Followed is that by a brief introduction in European health care history, an explanation of the general regulatory framework and the detailed description of the steps required to get market approval for a device. After examining the mechanisms of the conformity assessment procedure the post-market phase will be described briefly. The chapter ends with a case study on the recent breast implant scandal and will point out existing gaps in the current framework.

After analyzing the European regulatory system the focus will switch to the U.S. and its procedures in Chapter 4. Starting with an introduction of the legal background it will analyze the differences between the pre-market notification and the pre-market approval process. This is followed by describing procedures concerning the device production and quality management and will continue with a short outlook on the post market phase. The chapter will close with the description of a recent case of regulatory failure.

The final chapter will summarize and compare the two systems and then give recommendations about how the two systems can be improved to overcome some of the failures identified in the case studies. The thesis will end with a critical acclaim and an outlook on future developments in the field of medical device regulations and further study opportunities.

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2. Economics of Health Care

British economist Adam Smith argued in his 1776 book An Inquiry Into the Nature and Cause of the Wealth of Nations that markets are efficient by themselves and need no intervention to function perfectly. He argued famously that participants in a market (households, firms) are motivated by self-interest and that they interact as if they were guided by an invisible hand, which transforms their self-interest into desirable market outcomes and general economic well-being. Price reflects the value and the cost of a good and is the instrument that is used by the invisible hand to guide the economic activities. Smith argued that the invisible hand will lead markets to allocate resources efficiently but this is not always true. Stieglitz argues that a market will only be sufficient if a set of conditions are fulfilled, such as perfect competition, no externalities, and perfect information (Stiglitz 2010, p. 2; Smith 2009). Economists speak of market failure if a market fails to allocate resources efficiently. In this case, it is sometimes necessary that the government intervene to improve the market outcomes (Mankiw, Taylor 2011, p. 11). Health care systems are largely characterized by a number of regulations involving the financing, the delivery of health care and the approval of pharmaceuticals and medical devices (Nuscheler 2005, p. 2).The introduction of regulatory rules is always impacting the competition and therefore it is important to analyze the reasons for regulation and its outcome.

The following sections of this chapter will therefore give a general overview of how economies work, subsequently give an explanation of several causes of market failure and will then demonstrate how regulations influence the markets with a focus on the medical device industry.

2.1 Principles of Economics

An economy consists of a number of participants who are engaged in activities such as working, manufacturing, buying, and selling. The word economy describes all economic activities that take place in a country or a region (Mankiw, Taylor 2011, p. 27). The circular-flow model (Figure 2) visualizes the market players and actions of an economy. In this model, the two decision makers are households and firms and will later be modifies for the medical device industry, demonstrating the impact of the government as an additional decision maker (see Chapter 2.2).

The firms use the factors of production (labor, land and capital) to produce goods and services.

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They interact on two markets: 1) the markets where the households sell and the firms buy, and 2) the market for goods and services where the firms sell the goods produced and the households buy them. The circular-flow diagram shows in a simplified way how an economy works and how the decision makers interact with each other.


By definition, a market is a group of buyers and sellers of a particular good or service. The supplier is the one producing and selling a good to the buyer who is in demand for it. Markets can have any form; they can be very organized such as the metal market, or less so as in the case of the coffee shop market. Each seller sets a price for his products and each buyer evaluates how much he is willing to pay for that particular product (Mankiw, Taylor 2011, p. 68).

As mentioned earlier, Adam Smith assumed that markets are efficient by themselves through an invisible hand that perfectly allocates supply and demand. This premise assumes that markets are perfectly competitive which means that 2 conditions are in place: 1) all goods on the market are homogenous and as a result the buyers have no reason to prefer one over the other; and 2) the buyers and sellers are so numerous that a single one cannot influence the market with its own strategy. This leads to the conclusion that all market participants have to accept the price determined on the market as no single entity has enough market power to set the price. An example is the wheat market where thousands of farmers are in competition and one single seller cannot influence the global wheat price (Mankiw, Taylor 2011, p. 70; Niedbal 2005, pp. 168 f.).

In reality, not all conditions for a perfectly competitive market are always fulfilled. Economists speak in this case of market failure. For example, sometimes there is only one firm producing a certain good and that seller can set the price. This seller is called a monopoly. An example is for this is the water supply in a certain region where all residents can only buy this service from one company (Stiglitz 2010, p. 11; Mankiw, Taylor 2012, p. 377).

There are some markets that are neither perfectly competitive nor a monopoly. One of them is called oligopoly, where few sellers are offering the same product in the same market and do not compete aggressively (Mankiw, Taylor 2011, p. 877). An often used example are airlines who service the same route and who rather both keep their high prices and avoid rigorous competition than aiming to become the monopolist. Another example is the imperfect competition where many sellers offer slightly different products and are therefore able to set an own price for their product (Stiglitz 2010, p. 2).

Regulations are designed by the government to address market failures. This is the case for the medical device market; several factors contribute to the fact that it is not efficient by itself.


Goods can be divided into four categories by asking two questions:

1) Is the good or service excludable? Can people be prevented from using it?
2) Is the good rival? Does one person’s Use of the good diminish other people’s Use of it?

The diagram below shows the four goods and examples for each of them.

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Most goods and services in the economy are private goods, which are both excludable and are not joint in consumption. Since private goods are not an influence for health care regulations there will be not further focus on them (Ravenhill 2011, p. 71).

Public Goods are neither rival nor excludable which means that one person’s use does not exclude another one from using it as well and that people cannot be prevented from using it at all. One could argue that in health economics, foundational research is a public good as everybody can use the findings without reducing the ability of another person to use it and nobody can be excluded (Mankiw, Taylor 2011, pp. 222 f.). In reality, this is not entirely true as innovations (such as new medical devices) based on new findings are usually patentable and therefore the knowledge might be accessible but not usable for everybody (Reimers 2009, pp. 62f.; Ujlaky 2005, p. 116).

In the case that a good is excludable but not rival, economists speak of a natural monopoly. There are several examples of monopolies in the medical device market which are caused by the regulatory framework and therefore do not count as natural monopolies[1] but the ambulance is an example from health economics. It would be no problem for an ambulance not to come and save people, yet this service is not rival and there is no reason why an ambulance should do so (Lauterbach 2010, p. 121).

The last group of goods is common resources which are rival but not exclusive. For common resources and public goods externalities arise since these goods clearly have a value but no price attached. Because one might not identify the value correct the allocation of resources might be inefficient and the government has to intervene to raise the economic well-being (Mankiw, Taylor 2011, p. 223).


By definition, an externality arises when a person engages in an activity that influences the well-being of a bystander (a third party) who neither pays nor receives any compensation for that effect (Mankiw, Taylor 2011, p. 198). If the impact for the third party is beneficial, economists talk about a positive externality. If it has a damaging impact, it is called a negative impact. An example for a positive externality from health care economics is the spread of communicable diseases. Getting a vaccination does not just prevent the patient itself from being infected, but it also reduces the general contagion risk. A psychic negative external effect would be the sickness of a child that affects a mother in such way that her own health is in danger as well (Reimers 2009, pp. 61).

When sellers and buyers decide how much they supply and demand, they are guided by their self-interest (invisible hand) and do not take the external effects of their actions into account. The market equilibrium is therefore not efficient when externalities occur. Each government implements regulations to limit the effect of externalities, such as zoning restrictions or environmental regulations (Stiglitz 2010, p. 3). Taking smoking as an example, which does not just affect the smoker but also individuals in the direct environment, the government puts high taxes on cigarettes as the smoker does not internalize the negative external effects himself (Nuscheler 2005, pp. 3).

Asymmetric Information

Another reason for market failure is the asymmetry of information. The term simply describes the case that one person or group knows more than another. This plays an especially important role in health economics since most of the times one person (the doctor), called agent, is performing a task (selecting the pharmaceutical or the medical device) on behalf of another person called principal (Reimers 2009, pp. 65).

Moral Hazard describes the case when the principal cannot control or monitor the agent’s actions and therefore the agent tends to engage in dishonest or undesirable behavior (Schölmerich 2005, p. 2). An example from health economics is the behavior of a person with health insurance (agent) and his insurance company (principal). The agent has more information about his own health and lifestyle than the insurer. Knowing that in the case of a damage (injury, disease) he will be covered by the insurance, the agent might engage in dangerous actions (bungee jumping) or live a knowingly unhealthy lifestyle (smoking, drinking alcohol). Since the principal cannot control the actions of the agent, and the agent knows that he is not fully responsible for the consequences of his actions, Moral Hazard leads to opportunistic behavior (Lauterbach 2010, pp. 130; Reimers 2009, pp. 65).

Another type of asymmetric information is the adverse selection problem. This problem occurs when one party has more or different information about the good or service that is transacted than the other party. In this scenario, the ‘selection’ of the good may be ‘adverse’ from the standpoint of the other party to the transaction (Mankiw, Taylor 2011, p. 468). Adverse selection can occur in the private health insurance market when the buyer knows more about his own health status than the insurer. A person with a pre-existing condition is more likely to proactively seek insurance than a healthy person; and insurers knowingly inflate insurance premiums based on this assumption. Consequently, healthy buyers might not be willing to pay that price and may be discouraged from getting health insurance at all (Lauterbach 2010, p. 128; Barry et al. 2002, p. 48).

Irrational Behavior

In economic theory, it is assumed that humans always act rationally; they maximize profits if they are the manager of a firm and they maximize utility if they are the customers. In reality, people are not always the rational and calculating Homo economicus; but rather are impulsive, emotional and short-sighted (Rogall 2006, pp. 58). Smoking is an example of such irrational behavior. Assuming most people are aware of the fact that 1) smoking endangers their health and may lead to cancer and 2) governments place high taxes on cigarettes and try to prevent people from smoking, there is no rational explanation why people would smoke. Still, even though people are aware of the health risks and the addictive effect, millions of people smoke regularly. Since the cost in case of a disease caused by regular smoking will be paid by the health insurance, the irrational individual will not recognize the mistakes in his behavior and most likely, based on the Moral Hazard theorem, feel the incentive to take advantage of an excessive amount of insurance benefits.

Adam Smith believed that the invisible hand would allocate supply and demand efficiently and in that sense maximize the surplus for society welfare (Mankiw, Taylor 2011, p. 10). Taking into account what is known after this chapter about market failure, goods, externalities, asymmetric information and irrational behavior, it must be concluded that markets by themselves are not efficient. The health care market, including medical devices, is just one of many examples that show the need of governmental intervention to improve the market outcome by establishing regulations.

2.2 Regulating Markets

Having explained the reasons for market failures in the previous section it is clear why competitive markets do not always achieve an efficient outcome (Nuscheler 2005, p. 3).

Depending on the reasons that cause the market failures, different types of regulations apply to mitigate their extent which will be explained in the following.

To decrease the occurrence of externalities, governments regulate a variety of markets in different ways. In order to reduce and repair the damage of environmental pollution, governments have established laws, treaties, and taxes. These can affect households (owners of diesel cars must pay higher auto taxes in most countries due to the environmental impact), firms (production sites with high emissions are strongly monitored by the government and have to pay high taxes on their products), and countries (the Kyoto protocol dictates how much emission each country is allowed to produce) (European Parliament 19/04/2012; United Nations 1998).

To maintain competition on markets and to ensure that monopolies do not abuse their market position there are several laws and restrictions e.g. against anti-competitive practices, cartels, price fixing etc. There are also a large number of regulations that aim to protect the consumer. When it comes to protecting people, it is often a combination of protection from externalities, missing information, and irrational behavior. This can be demonstrated by the example of health care insurance system in Germany: people often underestimate their own health care costs and it could be assumed they would take insufficient care if the responsibility is left to them. Therefore the government enforces a 15.5% tax on the gross income of all citizens in order to fund a government-run health insurance program. Due to missing information (cost of certain diseases are unknown, 85.92% of their healthcare expenditure occur after their 65th birthday[2] ), people would not save the money adequately for the case of sickness (Statistisches Bundesamt 2008). Knowing that, the government intervenes and regulates health care insurance by enforcing a payment. Once people are insured and aware that the full costs of their health care are covered, they start to act irrational. Knowing the danger of free climbing, snowboarding or boxing people will still tend to do them. Feeling that they deserve the best treatment since they are forced to pay, it is a great incentive for the insured person to expand the demand for health services to the saturation amount. The rising demand for health goods has an effect for all insurance payers, as the insurance companies will increase the premium due to higher cost (Reimers 2009, p. 67; Rüter et al. 2011, pp. 620).

The regulation of medical devices is necessary as consumers must be protected from defective or useless equipment and the existing information asymmetry. If the market would not be regulated, based on which criteria should a patient choose a device? It is hard to believe any non-medical professional can evaluate the effectiveness and safety of a medical device and can offer a suitable price for the product.

To ensure the manufacturer does not exploit its advantage of information, governments have established different systems of regulations. In this thesis, the conformity assessment procedures of the U.S. regulatory system with its governmental agency and the EU regulatory system with its competent authorities and Notified Bodies (NBs) will be under review.

3. European Medical Device Regulations

3.1 General Regulatory Framework

European countries established national regulations for medical devices during the early 20th century. In 1969, the European Council attempted to harmonize the individual actions of the Member States regarding technical regulation and established a general program. This was unsuccessful as the timetable for the countries to adapt the new directive was too strict for the amount of work that had to be done (Frank 2003, p. 16). In order to take out the pressure, the Council established a supplement to the initial program, this time without timetable. In 1985 the Council adopted a resolution regarding the technical harmonization which was supplemented by the ‘Global Approach’ in 1989 (Frank 2003, p. 17). The new approach was introduced to all Member States[3] during the 1990s and is complemented by the Medical Device Directive, which was introduced in 1993 (World Health Organization 2010, p. 17). Conformity assessment of medical device is conducted by the manufacturer, a notified body and the national competent authority (Frank 2003, p. 18).

Notified Bodies

Notified Bodies (NBs) are independent, mostly private organizations which are nominated and monitored by the Member States of the European Union. In the field of medical devices, it is the responsibility of the NBs to conduct the conformity assessments for medium and high risk products. The Member States have to ‘notify’ the European Commission and all other Member States about the identity of the NBs in their region and its official ID number. To be nominated, the NB must fulfill the requirements prescribed in the MDD, including availability of personnel and equipment, independence, confidentiality and required knowledge. The Member States are free to nominate NBs within their territory, but need to control and oversee the activities of it through continuous surveillance. If an NB fails to maintain its credentials, the Member State may withdraw the notification status (Frank 2003, pp. 47). The European Commission publishes a list of all NBs on their homepage and in their Official Journal (European Commission 2012b).

Manufacturers are free to choose any NB in the European community no matter where it is situated. Although all NBs must fulfill the MDD requirements in order to perform a conformity assessment procedure, they have different areas of expertise. The manufacturer may choose, depending on the type of device, the NB with the most extensive experience for their product type. Particularly in countries that had its own regulatory system before the EU harmonization in the 1990s and the establishment of Directive 90/385/EEC (i.e., Germany, the UK), authorities have experience with carrying out conformity assessments (Frank 2003, pp. 48). Once chosen, manufacturers usually stay with the same NB for all procedures but it is not a requirement to do so.

To assure that medical devices have the same quality no matter where it is manufactured and where the NB is situated it is necessary for the European Commission (EC) to review the effectiveness of the regulatory system on a regular basis.

Definition of a Medical Device

The European Medical Device Directive (MDD) Council Directive 93/42/EEC, set up in by the European Parliament commission in June 1993, defines in Article 1 that

‘medical device means any instrument, apparatus., appliance, software, material or other article, whether Used alone or in combination, including the software intended by its manufacturer to be Used specifically for diagnostic and/or therapeutic purposes and 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’ (European Parliament 14/06/1993, pp. 5).

Medical devices and medical accessories are products whose only intended purpose is a medical purpose. There is a broad range of products that are used to prevent diseases but are not considered medical devices according to the MDD definition. Those products do not fulfill the criteria of a medical purpose as they often have a cosmetic or toiletry purpose for example tooth brushes, contact lenses without corrective function or dental sticks (Frank 2003, pp. 29,85). It makes no difference whether the device is intended to be used alone or in combination with other products to fulfill the medical purpose. It is the device manufacturers’ responsibility to control the raw components and assure high quality as this can influence the performance of the end product (Frank 2003, pp. 32,40).

Medicinal Product

Medical devices should not be mistaken with medicinal products, which are regulated through the Medicinal Products Directive 2001/83/EC5 (MPD). A Medicinal Product is ‘any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be Used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis ’ (European Commission 21/03/2010, pp. 8).

The purpose of medical devices and medicinal products are both to treat, prevent and diagnose diseases. The difference between them is found in the intended purpose and their mode of action: medical devices fulfill their function by physical means, while medical products act on the body in a pharmacological, immunological or metabolic manner.

As technologies become more and more sophisticated, an increasing number of products are introduced to the market which combines the characteristics of medical devices and medical products. Drug-delivery products are one such example where the kit containing the insulin pen would be regulated by as a medical device under the MDD, while the insulin cartridges are medical products regulated through the MPD.

In order to determine the applicable directive, it is necessary for the manufacturer to define the intended purpose of the product and then to define the product’s primary mode of action; that is, the mode of action with the most significant therapeutic effect on the body. The primary mode of action is established through the manufacturers rational assessment of bench, animal and human data and this decision is later evaluated and approved by the NB (Frank 2003, pp. 32). There are about 4,000 CE-certified medicinal products on the EU market but more than 250,000 medical devices (Hansen 17/01/2012, p. 4). Examples for Medicinal Products are Spermicidal preparations or gases intended to be used in anesthesia and inhalation therapy (European Commission 21/03/2010, p. 9).

Special Devices

There are a number of devices that require special attention; some will be described in the following such as active implantable medical devices, in vitro diagnostic medical devices, human tissue, and medical devices incorporating human blood or human plasma.

The Active Implantable Medical Device Directive 90/385/EEC (AIMDD) defines an active implantable medical device as a device which relies on a source of electrical energy to function properly; and, which is intended to remain inside the body after the implantation procedure. According to the definition outlined in the AIMDD, the source of power must be other than gravity or the human body itself to be considered an “active” device. Examples of active implantable devices are implantable defibrillators, cardiac pacemakers or drug administration devices (European Commission 21/03/2010, pp. 13; Frank 2003, pp. 30).

According to the MD Directive 98/79/EC, an in vitro diagnostic medical device is any device used for in vitro analysis of human body samples (i.e., glucose and hepatitis tests). A broad variety of products fall into this category, most of which do not contact the patient but could lead to a misdiagnosis in the event of a malfunction. Such a misdiagnosis and could have a great impact of the users health if they fail to receive medical treatment, or receive unnecessary medical treatment, as a result of this misdiagnosis. This directive also regulates self-testing devices such as home pregnancy tests, which are used by the patient without professional assistance, and are thus referred to as “over-the-counter” or “OTC” products (Frank 2003, pp. 31).

Medical devices incorporating human blood and human plasma derivatives are considered a borderline case. Borderline cases are those cases where it is not clear whether a product falls under the MDD, the AIMDD, or the MPD. The European Commission is working on a decision whether to include products incorporating tissues of human origin into the MDD or to establish an independent directive. While such a decision is pending, the regulation of human tissues is in the responsibility of the Member States (Frank 2003, pp. 32,36). The term ‘human tissue’ relates to all parts of the human body such as bones, skin, veins, and cells with the exception of whole organs, blood and blood products. Although products derived from human blood or plasma would be a medicinal product since their function is not by physical means, it is currently assessed and authorized in accordance with the MDD and Member State law (European Commission 21/03/2010, pp. 14).


Table 2: European Medical Device Classification, own compilation based on

(European Commission 1/06/2010, pp. 17)

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According to the MDD, medical devices are grouped into 4 classes. The classification is ‘based on the vulnerability of the human body, taking account of the potential risks associated with the technical design and manufacture of the device’ (European Commission 1/06/2010, p. 4). The risk classes according to Article 9 MDD are: Class I for low risk medical devices, Class IIa and IIb for medium risk, and Class III for high risk devices. The rules to which class a device belongs depends on the degree of invasiveness and how much the use of the device affects the anatomy of the patient.

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According to the MDD, it is the manufacturer’s responsibility to determine the product class for the devices they bring into commercial distribution. If several rules could apply for a particular medical device, the manufacturer is required to apply the rule which results in the highest classification. In cases of doubt, the manufacturer should consult the NB for a formal opinion (Frank 2003, p. 44).

In only one specific incident the EC changed the classification for a product on request of citizens, who handed a petition to the EP. In 2003 breast implants were reclassified from Class IIb to Class III on requests submitted by France and the United Kingdom (European Commission 3/02/2003). The European Parliament ordered research on the matter evaluating studies which showed no evidence that breast implants pose a high risk to the health in general. However, the EP recognized that breast implants have a high risk of adverse events[4] and asked the EC to draft a change in regulations (Frank 2003, p. 44).

3.2 Conformity Assessment Procedure

Once the manufacturer believes the product is ready for the market, the process of conformity assessment by the NB can begin. In this process, the manufacturer must demonstrate that the requirements for products stated in the applicable directive are met. Under the MDD, these are referred to as the ‘Essential Requirements’. The conformity assessment process is performed by submitting the necessary laboratory, animal, and human testing to the NB in the form of a technical dossier (Hansen 17/01/2012, p. 7). A determination of what testing is required is performed based upon the risk assessment for the product which identified potential failure modes and critical quality, performance, and safety attributes; as well as any available international standards or guidance documents on the product type. Depending upon the device classification, this technical dossier can also include information about the quality system of the manufacturer, the actual design process of the subject device, the manufacturing process for the product and critical intermediates (Frank 2003, pp. 51).

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Articles in the Directives

There are several Articles in the Medical Device Directive, which differ according to the stage, type of assessment, and person monitoring. Conformity assessment procedures can be carried out for a design of a product or a full product, for type approval or full quality assurance and could be completed by a NB or the manufacturer himself depending upon the device type. The aim is to provide information about the product and to demonstrate the conformity with the Essential Requirements[5] (European Commission 15/01/2001). Once conformity is established, a written statement, the EC declaration of conformity, is prepared by the manufacturer stating that the medical device is produced in accordance with the applicable directive. The declaration must be kept for 5 years and has to be provided upon request by authorities. Since no format is given for the EC declaration, the European Confederation of Medical Suppliers Association (EUCOMED) has established guidelines available for all manufacturers. The EC declaration is the first step for manufacturer towards the market approval and is published before the NB enters the conformity procedure (Lindemans 2008; Frank 2003, p. 51).

For most medical devices the involvement of a NB is required except for some Class I devices. This device type represents the lowest risk to the patients and thus can be self-certified by the manufacturer according to the MDD (European Commission 1/06/2010, p. 5). Examples of these product types are tongue depressors and external bandages. Under this process, the manufacturer has the sole responsibility to ensure the device conforms with the Essential Requirements and must provide technical details and complete manufacturing documentation to authorities at any time (Frank 2003, p. 43).


The CE-marking (abbreviation of French Conformité Européenne, meaning European Conformity) is a products ‘passport’ as industrial goods with this certification are allowed to move freely within the Member States (Frank 2003, p. 52). CE marking is not exclusively for medical devices but also for a broad range of other products which require assessment prior entering the market (World Health Organization, p. 3).


[1] Example: If a new innovation is approved for market entry by the FDA it often has a monopoly as there is no similar product available. The Kyphon Balloon for Kyphoplasty produced by Medtronic to repair spinal fractures is the only product which got approved in the U.S. for this type of surgery and therefore has a monopoly (Gaitanis 2005).

[2] According to data collected in 2008, figures might change due do ageing population

[3] Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, Sweden, Switzerland, United Kingdom European Commission 2012a

[4] An adverse event is any harmful and undesirable experience associated with the use of a medical product or drug (Frank 2003, p. 58)

[5] The Essential Requirements Checklist can be found in the Medical Device Directive 93/42/EEC, Annex I.

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A Comparative Analysis of Medical Device Regulations in the EU and the USA
Berlin School of Economics and Law
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Ann-Marie Jahn (Author), 2012, A Comparative Analysis of Medical Device Regulations in the EU and the USA, Munich, GRIN Verlag, https://www.grin.com/document/197712


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