The Medical Device Directive was first published on June 14th 1993 by the European Commission as a way to streamline the medical device market among its member states. The number of different pieces of legislation and legalities that could now be overruled so that the market in the territories of the member states was a free one was massive. The Medical Device Directive is long and complicated, especially if you have a limited amount of knowledge on medical devices or international treaties. However for the manufacturers and regulators, the directive simplifies, regulates and maintains standards among all the member states of the European Commission (EC).

To help manufacturers comply with all the points in the new directive, several articles were added which offer a clear definition of what a medical device actually is, and how countries should trade them.

The definition of a medical device is laid out in Article 1 which states that any instrument, apparatus, material, appliance or other articles is a medical device if it is used alone or in combination with something to perform one of the following functions. These might be to treat, diagnose or prevent a disease. Also included are devices used in the control of contraception. Prosthetic limbs and joints are also considered to be medical devices. When injuries and handicaps occur, the treatment, diagnosis and alleviation of them are medical devices.

You can see in the amount of detail in this definition that the medical device Directive is aimed at making members clear of what is and what is not a medical device.

Although the EC passed the directive as a collective, some individual states were not as enthusiastic as others. So that countries could not block some devices, Article 4 claims that no member state can place obstacles in the way of a device entering the market in their territory if the EC has passed it for use. however no device without the CE mark of conformity can be used an EC member state.

Manufacturers of devices who supply or make products in the territory of EC member states need training on the Medical Device Directive so that they can conform with the regulations. Regular training should be given so that any amendments or add-ons to the directive can be worked into production processes.

The American Food and Drug Administration is set to increase its medical device regulation over radiation-emitting machines used in healthcare. Over recent years there has been growing concern that there is not enough monitoring of the radiation equipment used on patients. There have also been episodes in the news when patients have been given extremely high doses of radiation by mistake and have only realised when their hair fell out. The concerns surround the use of radiation-emitting devices which are used during diagnosis as opposed to treatment, although therapeutic devices will also be looked at.

The FDA wants to cut the amount of radiation that patients are exposed to during their life through the medical device regulation. Three devices will be focused on intensely. The CT scan, where the scanner produces a 3D image of the body. Nuclear medicine studies where a radioactive product is injected into the body and studied by a doctor. And lastly, the fluoroscopy where a radiation emitting device projects an image of the body onto a monitor. The link between these machines is that they all produce ionizing radiation which can increase the risk of developing cancer over a patient’s lifetime. Women and children are most at risk and there are other health issues which arise when an accidental overdose of radiation is given including skin burns, hair loss at cataracts.

There has been much discussion about the regulation of these devices in the past. There have been reports of machines being incorrectly programmed so that they produce too much radiation, or the safety precautions have not been followed properly. The health problems mentioned above can be a result of this. Consumer groups and health watchdogs have found that there is only a small number of laws and regulations with the aim of protecting patients from these machines however they are poorly applied and weak. And, although the FDA has jurisdiction over radiation-emitting medical devices, they have allowed manufacturers to release a number of them onto the health market without testing their safety and efficiency.

The increased medical device regulation will help to reduce the number of patients being exposed to radiation during diagnosis and therapy or at least reduce the amount of radiation which is emitted during the tests.

Conformity is of paramount importance when it comes to the pharmaceutical industry and the medical device directive is something that manufacturers need to be aware of when producing medical devices and other pharmaceutical goods. Understanding what is expected of them during the manufacture of medical products is essential for manufacturers and it is something that can only really be accomplished through following things like the medical device directive and utilising the services of pharmaceutical consultancy firms.

Safety is paramount amongst the regulators of the medical device industry and this is why they came up with a set of manufacturing guidelines known as the medical device directive – and this is something which needs to be born in mind during every step of the manufacturing process. Ultimately, the responsibility for ensuring the safety of the manufacturing processes lies with the pharmaceutical company in question and the medical device directive needs to be viewed as a set of guidelines that will help them in facilitating these good manufacturing practices.

The medical device directive applies to all types of medical device but a lot of the emphasis is placed on the more high risk products that reach to market, such as life support machines. Class III medical devices or, more specifically those machines responsible for the prolonging of life, are considered the most high risk products during manufacturing and the medical device directive offers guidelines on how best to manufacture such apparatus.

It is clearly essential to comprehend that the medical device directive is just a set of guidelines which the regulatory bodies have formulated to help govern the production of medical devices and manufacturers should consider the use of pharmaceutical consultants to ensure that they are compliant in all areas. The pharmaceutical industry is clearly extremely large and needs to be regulated with great care and this is something that the medical device directive is concerned with helping to ensure.

The monitoring of the medical device field is understandably very stringent and issues of medical device regulation arise regardless of the type of product being manufactured. It is important to realise, however, that manufacturers may struggle to keep up to date with all the different legislation that permeates the pharmaceutical industry and using the services of pharma consulting companies is likely to be extremely beneficial.

The sheer size of the medical device industry means that it generates billions of pounds each year and, as a result of this, is fairly difficult to regulate. As such, it is important to seek out experts in the field of medical device regulation, who will be aware of all the factors that need to be taken into consideration when manufacturing medical devices – both big and small.

Of course, it is the safety of products that is at the core of medical device regulation and it is absolutely essential to make sure that manufacturing practices are compliant with all the latest legislation – regardless of whether you are making surgical gloves or dialysis machines.

The pharmaceutical industry is famed for the speed with which legislations change and this is largely due to how quickly technology develops amongst manufacturers – being up to speed on medical device regulation is, therefore, crucial. In addition to this, new materials are continually being developed and utilised in the production of medical devices and these materials need to be analysed to make sure that they are safe for the end user i.e. the patient.

Making sure that manufacturing practices are compliant with medical device regulation is clearly extremely important and having expert assistance is one of the best means of achieving this.

The US Government Accountability Office GAO has used pharmaceutical consultants to look into people working for the FDA and the results are a damning criticism that the Food and Drug Administration hires criminally convicted doctors to work for it in clinical trials. This is a damning indictment of the FDA who has even been found to be breaking their own rules when they fail to debar these personnel when they are discovered to hold a criminal record.

GAO officials have publicised their records which show that it takes the FDA an average of four years to debar convicted medical practitioners from working with them. This is despite the fact that the administration is required by law to disqualify doctors who have been found guilty of fraud or other crimes. In one case it took the FDA 11 years to disqualify a doctor who had been convicted of 53 charges including covering up a patient’s suicide during a clinical trial.

Other cases involve medical professionals who have committed fraud or prescribed medicines without a license. There are also major concerns over the fact that three doctors continue to work with the FDA even though they are known convicted criminals.

presenting false data at clinical trials was the dominant charge amongst the doctors. They made up statistics for non-existent participants, did not follow the research plan of the trial or failed to gain the informed consent of trial participants. And medical devices are one of the most contentious issues in this whole affair. Under present FDA rules, a doctor who has been convicted of a criminal offence is not prohibited from practicing in the medical device industry, which could be putting the lives of millions of people at risk, especially since inhalers used to treat asthma are thought of as a medical device.

Because the FDA is already breaking its own rules and laws governing it, there seems little reason to implement new regulations. Instead, they propose a wide reform of the whole health care system in America. There should be no room for a company executive to move into a senior role at the FDA, drug companies and the FDA should not think of each other as friends but the FDA needs to be seen as a regulatory body with the power to punish the companies; On top of this, doctors who have been found to break the law should be prosecuted and excluded from the health profession entirely.

The Food and Drug Administration has been heavily criticised by pharmaceutical consultants working for the US Government Accountability Office or GAO, for hiring doctors to supervise clinical trials who had been previously charged with criminal activity. This is a damning indictment of the FDA who has even been found to be breaking their own rules when they fail to debar these personnel when they are discovered to hold a criminal record.

GAO officials have publicised their records which show that it takes the FDA an average of four years to debar convicted medical practitioners from working with them. This is despite the fact that the administration is required by law to disqualify doctors who have been found guilty of fraud or other crimes. The FDA seems to be ignoring these laws to such an extent that one doctor worked at the FDA for 11 years even though he had been previously charged with 53 counts of criminal activity.

Prescribing medicine without a license, fraud and lying during clinical trials were other charges that doctors had been committed of. There are even three doctors who continue to work with the FDA despite knowledge that each of them have a criminal conviction.

One of the main charges that the doctors had been found guilty of was falsifying clinical trial data. They made up statistics for non-existent participants, did not follow the research plan of the trial or failed to gain the informed consent of trial participants. There is also a contentious issue over doctors who have been found to break the law over medical devices. At present there are no laws to prevent doctors barred from medicine to work in the medical device industry which means that they could be endangering the lives of millions of people, like asthma sufferers.

With the FDA already breaking rules and laws with no regard for the consequences, there seems little point in simply applying new regulations. Instead many critics are calling for a wide reform of the whole health care regulatory system. There should be no room for a company executive to move into a senior role at the FDA, drug companies and the FDA should not think of each other as friends but the FDA needs to be seen as a regulatory body with the power to punish the companies; On top of this, doctors who have been found to break the law should be prosecuted and excluded from the health profession entirely.