Medical Devices as an Integral Facet of the European Union Health Care Sector - Essay Sample

Abstract

In Europe (EU) the new Medical Devices Regulation (MDR) entered into force in April 2017, it set in motion a three-year countdown for the stakeholders/industry to the new rules' full application in 2020. For stakeholders/ industry marketing devices in the EU that wish to continue to do so, there is a big workload to do in a relatively short time, so it is essential to be prepared as soon as possible. In light of this, the thesis examines the impact of the new MDR to legacy products; the key changes between the old and the new legislation with focus on the timelines and the impact on impact on industry stakeholders and the public.

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The study was qualitative in nature and used secondary data. It was found that there are many changes that have been introduced in the new MDR. Moreover, there are timelines that have been specified when these changes must be implemented. For some smaller manufacturers the new MDR becomes a burden and they will possible not be able to introduce all of their MD's to the EU market in time, this will possible be leading to a reduction of available MD's and state-of-the-art technology available for European citizens. The study concludes that all medical device manufactures should start preparing for the new changes and establish strategies that will help them meet the new changes.

Introduction

Medical devices form an integral facet of the European Union health care sector. Ranging from X-ray scanners to plasters, hip joints to dentures and in-vitro devices that help in identifying infections or monitoring diabetes, medical devices are essential in diagnosing, monitoring, preventing, and treating diseases (Hervey and McHale 2015). In addition, they contribute immeasurably towards the European country, providing over EUR100 billion in sales and 670, 0000 jobs (Behan, Pandit and Watson, 2017). Under the jurisdiction of the EU, a medical device is defined as;

"an apparatus, an instrument, material, appliance or any device that is used for medical purposes including diagnosis, monitoring, prevention, alleviation, or treatment of an illness."

In 5th April 2017, the EU introduced new medical device regulation (MDR) that made changes to the previous directives. The new regulations that will fully be effected on 25 May 2020 represent significant development aimed at strengthening the existing regulatory framework for medical devices and will replace the current directives that have been in place for over two decades (European law and publications EUR-Lex 2017). Whilst the new EU MDR aims at establishing a robust, transparent, and sustainable framework for medical devices manufacturers adhere to high levels of standards and safety, the regulations will have significant impact on legacy products; key changes, timelines, impact on industry stakeholders and the public. Statement of the Problem

The public relies on medical devices every day and expects them to be safe. They trust that the manufacturers and stakeholders take their responsibility to ensure that the medical devices on the market are safe and follow the latest scientific innovations and state of the art (Hervey and McHale 2015). The medical device branch is a fast-growing industry providing solutions in diagnosis, prevention, monitoring, treatment or alleviation of pain, injuries or handicaps, etc., in general medical care of the public.

In April 2017, the new Medical Device Regulation (MDR) was adopted and came into effect in May 2017. This regulation replaces two basic guidelines, the European Medical Devices Directive (MDD) 93/42/EEC and the European Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (European law and publications EUR-Lex 2017).

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (European law and publications EUR-Lex 2017).

At the same time the In Vitro Diagnostic Regulation (IVDR) was also adopted and came into force, the

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (European law and publications EUR-Lex 2017). The motivation or the implementation of these regulatory measures is in light of three conceptual issues in the European market; Firstly, the lack of digital single market and data specificity of the policy factors that are meant to hold the European market together. Instead, these policies only stipulate what entrepreneurs and businessmen have to while conducting business beyond the borders of Europe.

Secondly, the regulations on data have undergone significant adjustments in the recent past that have only contributed to layers of confusion and loss of clarity. Lastly, many of the data regulations in Europe lack independent specificity. Change was necessary to ensure that the specific ambitions and objectives of one regulation do not bombard with those of another.

If the objective to be the most competitive and the most dynamic knowledge-based was met, now the market strategy aspires to create a market in which consumers have unlimited access to digital goods and services throughout Europe, consisting of an unrestricted flow of digital data to enhance innovations and competition in the promotion of the growth of the European economy can be accomplished by 2020. The regulation runs on three primary forces; the economy, represented by the society which is the consumer, the environment, and access. Through these aspects, this regulation aims at changing the scope of the European market for the greater good of the economy.

Seeing as how the public relies on these devices for the improvement of the quality of life, policy makers have taken it upon themselves to ensure the safety of the consumer by holding the manufacturers responsible for their products. The developments in the market are meant to serve as a strategy to win back and retain public confidence in promotion of the new MDs.

However, the In Vitro Diagnostic Regulation (IVDR) will not be discussed in this master's thesis.

The new rules of the Medical Device Regulation (MDR) apply three years after entering into force. Therefore, the transitional period for MDR will end in spring 2020. Until this timeframe, the industry has to fulfil the entire obligation coming up with the new legislation (MDR).

Undoubtedly, some of the changes will be challenging for the industry, stakeholders and the public as of,

Challenges Facing the Medical Device Industry:

• Many MD's have to be handled in a very short time, which can be a serious problem for small and medium size companies
• Big investments have to be provided and planned to maintain all legacy products on the market
• Decisions have to be made about which MD's have to be abandoned, what will happen with these products, what is the impact to the public
• Lack of trained personal to handle the workload in relation to the new regulation
• In time Data Gap Analyses have to be performed to find out the lacking data

The new rules for the medical device classes and the fact that some MD's will switch to a higher class and therefore clinical trials have to be provided which takes some time to be planned and to be performed.

Challenges Facing the Stakeholders

• stakeholders have to be trained to handle all upcoming requests and to be prepared to provide qualified services
• the lack of MDR certified Notified Bodies (NB), which is indeed a limiting factor in sense of in time applications and approval of MD's

Challenges Facing the Public

• Some authorisation holders will possible not be able to maintain all their MD's on the market, what is the influence of these missing MD's?
• Will unmaintained MD's have a serious influence to the health care of the public?
• What will happen to unmaintained MD's?
• Is the health care being save in future in sense of MD's?

Indeed, the new medical device regulation has seeded countless questions such as the ones that are highlighted above which are of importance to the industry, manufacturers, stakeholders and the general public that expects safe and reliable MD's on the market. It is evident from the advancements in the field of medicine over time that medical devices are vital in the maintenance of health and come in a very broad spectrum. In addition to helping save lives on a daily basis, MDs significantly improve the quality of life for people with critical conditions involving sensitive organs such as the brain and the heart. With the introduction of new MDs in the market, there is growing concern among the public on their validity, authenticity, and possible effects. People have experience adverse effects with MDs in the past hence the increased level of caution.

It is these past experiences, which shaded MDs in bad light; they have led the EU policy developers to thoroughly push for the assessment of the new medical devices before their introduction into the market. The strategies used have not hindered the innovativeness of the industry. On the contrary, they have promoted the development of safe devices. Also, these efforts contribute towards transparency between the manufacturers, the government, and the most important effector of the market, the consumer whose confidence the policy makers target to win back. The regulations on the new MDs is bent on ensuring the protection of the consumer at all costs (European Commission, 2018). For instance, the manufacturers of these new devices will be required by policy to comply with the guidelines of the regulations or stop manufacturing MDs altogether. Additionally, they will be required to indicate the scope of the products used during manufacture that can cause adver...