Dit artikel wordt geciteerd in 1 The Need for a Regulatory Framework for Healthcare Single-market regulation and innovation in europe medical devices industry Medicines and medical devices have been in existence for centuries. According to the literature, there is evidence that scalpels, slings, splints, crutches and other medical devices were used as long ago as BCE by the Egyptians. Neither drugs nor medical devices are ordinary consumer products.
In most instances, consumers are not in a position to make decisions about when to use them, which to use, how to use them single-market regulation and innovation in europe medical devices industry how to weigh potential benefits against risks as no medicine or device is completely safe. While the concept of ensuring their quality has evolved gradually over time, the modern health products regulation started only after breakthrough progress in the nineteenth century, especially in chemistry, physiology and pharmacology.
Historically, countries have tended to introduce regulation or tighten existing regulation only when forced to do so by a public outcry over an unexpected and unfortunate event. Inthe death of over Americans who had taken a cough mixture containing an antifreeze-type chemical facilitated the introduction of pre-market testing to their medicinal regulatory requirements. Later, in the s, with the thalidomide incident, a tranquilliser and sleeping pills that caused phocomelia in newly born children as a side effect,2xResulting in the shortening or absence of limbs.
In fact, however, regulation for medical devices started relatively late, triggered mainly by a major public concern in the s and s regarding the risk of micro-shock from an electrical current via devices connected to patients. During the s and s, demand for stronger regulatory legislation arose from serious effects caused by intrauterine contraceptive devices the Dalkon shield and the Copper-7 device and several brands of tampons.
Beginning in the s, countries with a strong medical single-market regulation and innovation in europe medical devices industry industry4xAmong them Canada, United States, Japan and the European Union. These countries nowadays account for close to eighty percent of the medical devices market share. World Health Organization. The United States is the largest market for both pharmaceuticals and medical devices, which are estimated to be The European pharmaceutical and medical devices market is the second largest, representing Cunningham, B.
Dolan, D. Kelly, C. The medical devices industry is highly fragmented, consisting of small niche markets with only a few products. The highest percentage of these is based in Germany, followed by the United Kingdom.
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The industry includes companies such as Siemens, Hewlett-Packard, Philips and, GE-Healthcare, which operate mainly in electrical-medical equipment, as well as companies such as Boston Scientific and Medtronic, which dominate the implantable single-market regulation and innovation in europe medical devices industry sector. In comparison, around 5, applications were filed in the same period in the pharmaceutical field, most of them by applicants from the United States, followed by Germany, France and Switzerland.
Medicinal products refer generally to any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals.
Official Journal of the European Communities No. A product is classified as single-market regulation and innovation in europe medical devices industry medicinal product on the basis of either its presentation and therapeutic purpose or the type of action exerted by the substance. Official Journal of the European Communities no. P of 9 February By contrast, medical devices overall refer flirten mit schüchternen mann any apparatus, software, material or other similar or related item intended to be used in the diagnosis, prevention, monitoring, treatment or alleviation of frauen kennenlernen internet disease or injury and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
L of 12 July The foregoing shows that the difference between medicinal products and medical devices lies substantially in the interpretation of the main concepts that define them, namely therapeutic effect and mechanism of action. Racchi, S. Govoni, A. Lucchelli, L. Capone, E. Both medical devices and pharmaceuticals or, more precisely, medicinal products share the common property of exerting a therapeutic effect, although they are different in regard to their mechanism of action.
Medicinal products achieve their principal intended action in or on human bodies by pharmacological, immunological or metabolic means. In contrast, a medical device does not achieve its principal intended action in the human body by pharmacological, immunological or metabolic means but may be assisted in its function by such means.
Differences such as these justify distinct regulatory regimes. Developing a new medicinal product or a new use of an existing drug takes a long time; safety and efficacy must be proven before it can be brought to market. This process is enormously expensive because of laboratory, animal and various human trials, as well as high costs of trials needed for regulatory approval. Barton, J. DiMasi, H.
Grabowski, R. By contrast, the dimension, complexity and function of medical devices vary significantly. Hurdles to proving safety and efficacy differ according to the risk level associated with the use of the medical device: more complex and more invasive devices generally require substantial clinical trials dating bonn germany assessment before approval for market launch is granted, whereas non-invasive and low-risk devices face minimal regulatory hurdles before they can be marketed.
Interestingly, most of the earlier comparative studies on medical device regulatory framework concluded that Europe has been granting faster access to medical technology e. In a report22xJ. Eucomed press release 28 January ; D. Billingsley, European are left to their own devices, BMJ ; d doi: Further, Hwang et al.
Hwang, E. Sokolov E. Academic literature suggests that, compared with the Japanese market, medical devices in the European Union are available around five years ahead. There are several components of the European regulatory framework that are common to the countries manufacturing the vast majority of medical devices in use today e.
These elements will now be explained further. The European Union regulatory himmlische partnervermittlung for medical devices is quite young; it is twenty-five years behind the regulation of medical devices in the United States and about twenty-five years behind the European regulation of pharmaceuticals. Yet some components of certain medical devices might be covered by pharmaceutical regulation.
Another key difference between these systems is that in the United States, the FDA oversees all regulation of devices. In bekanntschaften nagold, the European system confers significant authority on a governmental body and private bodies to oversee device evaluation, market approval and post-market surveillance.
For this reason, Chowdhury28xN. This approach is based on the concept of single-market regulation and innovation in europe medical devices industry minimum set of mandatory essential requirements for safety and performance for a product to be sold in the European Union. Products in compliance with harmonised standards benefit from a presumption of conformity and can therefore be marketed throughout the whole Single-market regulation and innovation in europe medical devices industry Union area.
The choice of a directive rather than a regulation as a legal instrument for the regulation of medical devices in Europe denotes that, unlike in the pharmaceutical sector, which is subject to regulations, medical devices have a lower level of harmonisation, since the provisions of the directives have to be written into national law of each Member State.
Over the past few years, the system has been subject to amendments and has been complemented by standards and several non-binding technical guidance documents, reflecting the consensus of stakeholders regarding the implementation of the directives. Each Member State has its own Competent Authority who acts on behalf of the government to ensure that the requirements of the Medical Device Directives are transposed into the national law of that country. Each Competent Authority is also responsible for the designation and supervision of the conformity assessment bodies, as well as for post-market surveillance, including the report of adverse incidents of medical devices.
Besides the responsibilities cited in rule-making, the Competent Authority also has responsibilities for the approval and monitoring of clinical trials.
Typically, these competences are delegated to bodies such us Ministries of Heath, for instance in Italy,31xMinistero della Salute — Direzione generale dei dispositivi medici e del servizio farmaceutico. Germany33xBunsdesinstitut für Artzneimittel und Medizinprodukte. Despite their single-market regulation and innovation in europe medical devices industry competencies limited to the jurisdiction of the country where these dating kaiserslautern germany have been created, Competent Authorities participate actively in rule-making activities e.
Conformity assessment bodies, or so-called notified bodies, are certification organisations tasked with the enforcement of rules; most of them are privately owned and run commercial organisations. Their primary function is to carry out tasks related to conformity assessment procedures set out in the applicable legislation, which are aimed at demonstrating that the device complies with the requirements of the directive. They are, furthermore, responsible for suspending or withdrawing conformity certificates when they find that single-market regulation and innovation in europe medical devices industry device no longer satisfies the essential requirements set forth in the directives.
Manufacturers seeking approval to place a medical device in the European Union market are free to choose any notified body operating within the European Union, since there is no territorial linkage between the manufacturing site and the location of the notified body. This means that the manufacturer shares a contractual relationship with the notified body in which the former chooses the latter to undertake assessment.
Critics have argued that a commercial relationship of this kind may compromise public interest.
Feldschreiber, T. Robinson, PIP and Hips. It is noteworthy that a substantial share of literature shows that although the assessment procedures are the same de jure, there are some variations de facto regarding how notified bodies implement them,36xI. Santos, G.
European Medical Device Regulation is a handicap for the innovation hotspot Germany
Gazelle, L. Rocha, J. These disharmonies have resulted in widely differing quality in the performance of existing notified bodies. Fundamental to the regulation of medical devices in the European Union is the use of a classification scheme to determine the level of control over a device.
The classification of the device dictates the appropriate conformity assessment procedure: the higher the classification, the greater the level of assessment required by the notified bodies. This graduation is justified by the fact that medical devices cover wide-ranging products and it is more feasible and economically appropriate to categorise them rather than to subject all to the same rigorous conformity assessment procedure. French-Mowat, B. Similar schemes are utilised in the United States and other developed countries; however, while the United States has three classes of devices, the European Union and Japan use a four-class scheme.
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More precisely, medical devices in Europe are divided nominatively into three classes, but class II is divided into IIa and IIb with different requirements for each, so that, in essence, the European Union has four classes. This classification system considers the extent of human vulnerability to a device, as well as criteria concerning the time of uninterrupted contact of the device with the body and the degree of invasiveness.
Class I medical devices pose low risks associated with their use; manufacturers of these devices may declare to the Competent Authority conformity to the marketing requirements without a need to involve a notified body in this declaration. However, they must maintain a prescribed set of technical documentation available for inspection.
When clinical trials are involved, the ethics committee must be consulted. After the opinion of an ethics committee has been declared, and at least sixty days before an investigation begins, manufacturers may begin the studies unless notified to the contrary.
What Is the European Union Medical Device Regulation?
An annex to the directive contains general requirements for clinical investigations, including requirements for preclinical safety evaluation and protection of human subjects. It should be noted that, although clinical data are required for high-risk devices, the evidence requirements are vague, not available to the public and non-binding for manufacturers.
Generally, clinical trial is unnecessary for a device that utilises an accepted technology to manage a medical condition for which the technology is an accepted indication of use. For instance, for manufacturers claiming similarity to an existing product, a comparative literature review typically suffices. Sorenson, M. This database stores information on manufacturers, data related to approvals and clinical studies and details on post-market events. Despite the good purpose, the utility of EUDAMED has been criticised because so far it has been accessible only to national and European Union authorities; but not to the public.
When determining whether devices comply with the essential requirements set forth in the directive, notified bodies are expected to rely on national voluntary standards adopted pursuant to the so-called harmonised standards.
A device that meets all the foregoing provisions of the relevant legislation is granted the conformity mark in one Member State. This mark means, among others, that the device can be freely marketed in all the other European Member States and the European Economic Area EEA without further controls and no further evaluations. Thus, if, for instance, a German notified knipoog flirten approves the device, then the manufacturer can market it immediately in France, Italy and any other European Union country.
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This is significantly different from the position for medicinal products, for which market approval is needed in each Member State unless the centralised approval through the European Medicine Agency EMA is available.
In the post-marketing phase, manufacturers are required to report all serious adverse events to the Competent Authorities; all that information is further collated into the EUDAMED database.
Single-market Regulation And Innovation In Europe Medical Devices Industry
The post-market surveillance comprises both active monitoring of medical devices during their use and the notification to Competent Authorities of those situations that led or have led to serious injury of a patient, user or other person, death of a patient, user or other person; severe deterioration of the state of health of a patient, user or other person; or significant damage of the device.
Reporting was voluntary from untilwhen it became mandatory for manufacturers to directly report adverse events.
Cathrin Nastevska Kommunikation Fraunhofer-Gesellschaft Patient safety is top priority in medicine and biomedical engineering.
Eikermann et al. Eikermann, C. Single-market regulation and innovation in europe medical devices industry, M. Perleth, C.
Wild, S. Sauerland, I. Gutierrez-Ibarluzea, S.
Single-market Regulation And Innovation In Europe Medical Devices Industry
Antoine, J. Demotes-Mainard, E. Furthermore, as evidenced before, the lack of uniformity in the designation and monitoring of notified bodies among the Competent Authorities has been identified by various scholars as one of the prime reasons for the widely differing quality in the performance of notified bodies. Such segmentation has undoubtedly led to different levels of health and safety protection and has created obstacles to the internal market.
At the same time, efforts towards harmonisation have been hampered by uncertainties due to regulatory gaps derived from new medical device technology that has been developed in the past years.
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Redberg explains: In the past years the number and complexity of medical devices has exploded … in contrast to most devices in the s, the newer products pose substantially greater risks — even life-threatening risks — to patients. These advances, however, challenge the legally single metzingen concepts of a medical device and the associated boundaries of regulation. Underlining the need to consolidate and simplify the regulatory framework, promote its uniform interpretation across Member States and fill in the regulatory gaps that emerged with regard to a number of new technologies, the Commission initiated in a fundamental revision of the three Medical Device Directives.