Single market regulation and innovation in europe medical devices industry

Transcript of the speech, exactly as it was delivered Introduction Good morning, and thank you for giving me the opportunity to speak to you today. UK medtech sector We all know the medtech sector plays a vital role in the operation of the NHS, and the health of our population more widely. As a government, and as ministers, we are deeply committed to helping you — and the wider life sciences sector — to flourish.

Single market regulation and innovation in europe medical devices industry

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This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. The European Union and Canada use a slightly different classification system.

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While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing.

The modern era of implantable medical devices may be considered to have started in the s with development of artificial hips. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.

This is observed in all aspects of life, maybe nowhere greater than in medical care, where perinatal mortality, communicable diseases, malnutrition, and other public health issues dominate in poor — and noncommunicable diseases in the richer — countries.

The access to cardiac surgery, a specialty highly dependent on medical devices and technology, can serve as an example of uneven access.

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In the US, more than 1, cardiac procedures per million of population are performed every year. In Africa, the number is Although the demand in Africa is probably lower due to the disease panorama and age composition, the numbers illustrate the enormous difference in treatment availability.

The majority of the global population has no access to cardiac surgery or other therapies that require advanced technology and implantable devices. Even in developed countries, penetration of new technology may be slow.

A disconnect between the technological and medical communities is common, making translation of scientific discoveries into practical medical devices and procedures slower than necessary. Issues related to intellectual property rights IPRs are another hurdle. Even after successful clinical testing, the ultimate financial result of investments may be questionable, since payments for products and services through reimbursement mechanisms are not guaranteed.

Single market regulation and innovation in europe medical devices industry

The cost of such studies is often the responsibility of device manufacturers. This article will attempt to give an overview of major barriers to implantable medical device innovation and indicate possibilities for lowering such hurdles. The following topics will be discussed herein in an attempt to give a comprehensive review: Medical practice patterns and education Although medical practice is changing rapidly, there is an inherent conservatism in medicine that favors the status quo.

For new procedures and technology to become standard of care, randomized studies and meta-analyses are required. Even when such studies are completed years may pass before a device or procedure is widely utilized. This constitutes a concern for device developers who invest huge resources to get a device to market.

The period of high-income potential for the new product may be short, making it less advantageous to be the first out with new technology. The process of introducing new technology in hospitals is often complicated and depends on consensus between physician and administration.

Comparing this situation to the market for consumer technology such as mobile phones, the mismatch becomes obvious and critical. This can be partly understood as a lack of focus on emerging markets by medical device companies and lack of infrastructure and expertise in the health care systems.

Device companies may be reluctant to supply lower priced products for the emerging market, being afraid of cannibalizing their own products and eroding profit margins.The medical devices industry is a major employer in Europe, employing , people in the EU Total sales amount to € billion The sector represents some 27, companies, of which 95% are Small and Medium-sized Enterprises (SMEs).

Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation. Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European Medical Device Regulation (MDR).

At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of .


At Bryant Rubber, we pride ourselves on being the industry leader in providing high quality, tight tolerance precision molded components. and Ireland. This high level of employment shows that the medical technology industry is an important player in the European economy.

In comparison, the US medical technology industry employs around , people7 while the European pharmaceutical industry employs , people8. The European Social Innovation Competition awards outstanding projects that develop and showcase social innovations and entrepreneurial ideas across Europe.

The European Commission is now accepting applications for its first-ever Young Leaders of Industry Forum that .

Medical devices - European Commission