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.

Once again the risks of sexual enhancement products bought over the internet has been voiced by the US Food and Drug Administration after an investigation. A list of products designed to increase sexual performance was released by the FDA in 2004 because their ingredients were a risk to human health. FDA compliance was lacking as the manufacturers of these drugs were breaking federal law by refusing to fully disclose all of the ingredients in the sexually stimulating drugs.

Some of the ‘supplements’ included Actra-Rx, Actra-Sx, Libidus, Nasutra, Neophase, Vigor-25, Yilishen, Zimaxx, 4EVERON, and Liviro3.

These and the rest of the list are available to view on the FDA’s website. They are promoted as a pill to enhance sexual performance or treat erectile dysfunction. However, the ingredients in the drugs can have severe health effects on men who are already using other prescription drugs or indeed some herbal remedies.

The most recent product to be attacked by the FDA is Stiff Nights which is sold over the internet and in some retail outlets. The active ingredients are not listed on the website or on the packaging and it is listed as an all natural dietary supplement though this is far from the truth. The FDAs compliance regulations over the marketing of drugs is being breached by the company behind Stiff Night. It is illegal to withhold any ingredient information from your products because of the health risks posed when they interact with prescription drugs.

Men with conditions including heart disease, high cholesterol, high blood pressure and diabetes which are treated with prescription drugs are those most likely to be affected if they take sexual enhancement drugs and their prescription meds at the same time. Sulfoaildenafil is the main cause of this and it is the same ingredient that comes in the legal medicine Viagra. When this comes into contact with some nitrate drugs, a person’s blood pressure can dramatically fall to dangerous levels. Nitrates are commonly found in the medicines used to treat the above conditions and a side effect of them can be erectile dysfunction.

Because the product is advertised as ‘all natural’, many unsuspecting men are taking the drug without knowing that it could seriously damage their health. The FDA was warned about Stiff Nights following a customer complaint although the nature of the complaint remains undisclosed. After investigation the FDA deemed it necessary to produce their warning.

Very few people would say that pharmaceuticals affect our life in a major way. But it is a fact that most of us since our birth depend on pharmaceuticals in one-way or other. There is no age limit to who will use pharmaceuticals be it babies, teenagers or the elderly. The industry is governed by FDA Compliance which makes sure the medicines we take have been assessed for risk.

Pharmaceuticals play a vital role in our day-to-day living. So it is likely that we are concerned over the rising costs of medication. Even though pharmaceuticals might cause a strain on your finances, there is little to be done about it. In some circumstances, a person will have to spend money on certain drugs so that they can live a healthy life, no matter the cost. So the prices of drugs need to be watched and regulated so that pharmaceutical companies do not rip off patients. As of now many market leaders are found to price their monopoly drugs at a very high rate.

The research and development of new drugs is something that big pharmaceutical companies are involved with. A big amount of money is invested in the R & D branch of the industry. The miracle drug which can cure many ailments is something that every business is interested in finding. However once any drug has been developed it must be passed by the regulating authority, the FDA. FDA compliance governs the stages of research, development and manufacture that have been undergone for any new drug before being exposed to consumers. Only after it has been approved and given its quality assurance can a drug be sold to the public.

Animal and human tests are conducted on the drugs before they are given to the FDA for approval. During these tests the effectiveness of the drug will be confirmed and side effects will be examined and improved. All this research work is necessary so that the ultimate consumer gets nothing but the best.

The pharmaceutical industry is massively competitive and continues to be so as the medicines market grows. In order for companies to have a fair chance, the marketing of drugs is also regulated by the FDA.