CE Mark for medical devices – An option or a necessity?

Published on: 08 September 2018 Last Updated on: 12 May 2022

Ongoing evolution and revolution in medical, drug, and healing technologies have granted creative freedom in innovation and products in the market to make our lives safer and more comfortable. Yet the European Commission and European Union and the Member States maintain a balance between bringing new technologies onto the European market and the need to vete those technologies in advance for safety and efficacy, the two main elements of the risk analysis for medical devices, OTC drugs, and combination drug-devices. While patients may wish for an entirely open door to potentially healing and life-saving technologies, the Commission limits those technologies to account for effectiveness and risk per the various Medical Device Directives, the Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) Council Directive 93/42/EEC on Medical Devices (MDD) (1993) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998).

In addition, there is the consideration of a proper quality system in place to ensure that adverse events, impurities, and other key issues are taken into account by companies wishing to place medical products on the European Market.

What is a CE Marking?

A certification was required to ensure the safety, effectiveness, and quality of any medical product such as medical devices, before that’ product’s circulation in the market. Each country has it’s own regulations when it comes to importing the medical devices, such as overseas approval in Hong Kong where reference country approval can expedite the review process. This requirement led to the foundation of CE Marking in 1985. CE Marking or CE Mark is short for “Conformité Européene,” or in English “European Conformity.” The CE Mark is a kind of certification which indicates that a product lies within the health, safety, and environmental protection and quality standards as defined by EU directives. In simpler words, CE Mark is a sign that the manufacturer of the product claims that the product meets the appropriate regulatory requirements.

Why is CE Marking necessary?

CE Marking is the crucial ticket for your company’s medical device to the EU Market (read more on Medical Devices HQ) and to lend the opportunity for a greater success of the product.

The certification of safety is necessary for a medical product to ensure that there are no hazardous side-effects pertaining to health and the environment. Besides this, CE Marking is a legal obligation for placing a product in any market which comes under the legislation of the European Union.

Expansion into the global market is a key important factor for the commercialization of products for any manufacturer of medical devices. The European Union is too big and technologically advanced a market to be ignored. CE Marking is the crucial ticket for your company’s medical device to the EU Market and to lend the opportunity for a greater success of the product.

How to obtain CE Marking for your product?

To obtain CE Marking, it is of utmost importance that you observe each of the regulatory requirements specified by the European Union. This is for preparing your product strictly according to the predefined guidelines for CE Marking.

There are many complex imperative requirements in obtaining CE Mark for your product. Even after all the fishing and research, it happens quite often that your form for CE Marking faces some administrative setbacks.

It is important for a regulatory pathway for the medical product to be clearly delineated so you as a company have clear guidelines as to what needs to do, either via self-certification in the case of a Class 1 device or compliance with “Notified Body” (semi-governmental gatekeepers for medical products in the European Union) requirements.

Moreover, there are a number of overlapping EU directives and regulations involving many products, including the REACH Regulation, the Medical Device Directives cited above, the Biocidal Products Directive, and the Personal Protective Equipment Directive.

These are all important reasons for which is highly advisable to obtain professional assistance in drafting the form and other documents for the CE Marking of your product and especially for the key Technical File in the case of Class 1 devices. For example, while looking for CE Mark for medical devices in Israel, it is important for you to contact a legal person who will prepare or review a foolproof form and which, in turn, will ensure quicker delivery of the CE Mark for your product.

This CE Mark expert will make sure to categorize your product according to the set guidelines and do all the other Technical Documentation to show the compliance of your product with the regulatory requirements, along with the right Conformity Assessment Procedure. Hiring a professional law firm will ensure that, independent of the size of your business/ company, your form for CE Mark gets the necessary attention.

To sum it up

CE Mark, besides being an entry pass in the European market, is also a necessity for your medical device to flourish in any of the EU Member State markets. So, before submitting your form of CE Mark for Medical Devices in Israel, hire a professional to review your regulatory pathway into the EU first!

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Ways To Balance Your Life With Healthy Hearing

If you are looking for ways to maintain healthy hearing, there are several options to consider. These include eating a healthy diet, avoiding cigarette smoke, and keeping your ears clean. You can also take frequent breaks from listening, so your ears can get a rest. Here Are Five Prime Ways To Balance Your Life With Healthy Hearing 1. Eating healthy Eating healthy is the best way to keep your hearing health in top-notch condition. If you're looking for a quick and easy fix, consider making a habit of eating well and being physically active. This will improve your overall health and reduce your risk of chronic disease. Getting enough sleep is another smart move. While you're at it, don't forget to get your fill of vitamins and minerals. Boosting your Vitamin D intake will help you maintain good health and prevent otosclerosis. Omega-3 fatty acids in fish also aid in improving your acoustic performance. One of the best ways to make sure your ears are in tip-top shape is to include a wide range of food types in your diet. Some popular food choices include fish, fruit, vegetables, nuts, and legumes. A balanced diet will also help you manage your weight and avoid common health conditions. For example, if you're looking for the most important component of a well-rounded meal, try incorporating fresh ingredients into your recipe. Not only will you be healthier, but you'll also enjoy a more satisfying meal. Also, make sure to get your vitamins and minerals from a variety of sources. As a final point, you should make the time to try something new. Experiment with different foods to see what works for you. The most gratifying aspect of eating healthy is that it can lead to improved mood, more energy, and more social activities. Lastly, it's an opportunity to build a healthy habit you can enjoy for years to come. You'll never regret it. Get started by taking a look at the USDA's dietary guidelines. You might even be surprised by the quality of the recommendations you receive! 2. Exercising regularly If you want to keep your hearing healthy, then you must exercise regularly. Studies have shown that people who exercise have better hearing and a lower risk of developing presbycusis. Exercise increases blood circulation, which helps in keeping the brain and ears healthy. It also helps improve cardiovascular health and strengthens the immune system. Regular physical activity also reduces inflammation. Inflammation damages hair cells, capillaries, and nerve cells. By reducing inflammation, exercise also protects against age-related hearing loss. When mice were unable to exercise, they experienced worse damage to their ears than those who were active. Exercise can protect the ear from age-related inflammation and prevent presbycusis. Regular aerobic exercise and strength training can protect hearing in later life. The cochlea is the key component of hearing, and it is essential to maintain its health as one age. Many Americans are motivated to improve their physical and mental well-being, including their hearing. Exercise has many benefits for all parts of the body. A daily exercise routine can increase energy, improve sleep, and decrease stress. A study by the University of Florida found that exercise can slow age-related hearing loss. Exercise also reduced inflammation and increased the blood supply to the ear. Exercise is important for maintaining a healthy body weight, which is associated with hearing. Exercising for 20 minutes five times a week can reduce the risk of heart disease, diabetes, and other health conditions. For more information on how to exercise for healthy hearing, talk with a qualified personal trainer. Make sure you choose a form of exercise you enjoy. Choose a routine that fits your lifestyle and schedule. Exercise will protect your hearing for the rest of your life. 3. Taking listening breaks Taking listening breaks is one way to keep your hearing health in check. This could mean something as small as taking a nap during the day, or as big as switching out your hearing aids. Regardless of your circumstances, a little TLC now and then can make a world of difference in your quality of life. The fact of the matter is, a good old fashion nap is not always feasible during the work week. For that reason, it's important to take care of the ears on a regular basis. Luckily, many modern-day smartphones have apps that track your exposure to various noise sources. While it may be difficult to avoid all noise, reducing the amount of background noise is the most important step in the process. If you're stuck at the office, you can opt to try out eye yoga, or read a book on your Kindle or another portable reading device while taking a stroll along a park or other public space. Other activities to consider include attending a museum or visiting your local zoo. These activities are all great ways to get out and about while giving your brain a much-needed break. Another useful tip is to use headphones that are specifically designed for people with hearing loss. You can pick up a pair at your nearest electronics retailer or order a pair online. Using over-the-ear headphones is an excellent way to minimize your exposure to background noise. They also help ensure you get a better seal. Some of these devices even offer an optional earbud kit if you don't have one already. The best part is that a healthy ear is an invaluable asset that you can rely on for many years to come. So be sure to take the time to test out your hearing and reap the rewards! 4. Preventing water from entering your ear canal When you are swimming, you might get water trapped in your ear canal. This can cause discomfort and hearing loss. Fortunately, there are ways to prevent water from entering your ear canal. Before you start swimming, make sure you have some earplugs to use to block the entrance of the water. These are especially useful for swimmers. Swimming eardrops are also available. They contain alcohol and can help prevent water from entering your ear canal. After swimming, you may need to dry your ears. This is important because water can get into your ear canal any time you are underwater. If you can't keep the water out, you may experience a bacterial infection or fungal infection. If you have a bacterial or fungal infection, you should see a doctor. Your otolaryngologist can treat the infection with antibiotics. The doctor can also remove any remaining water from your ear. You can also try using hydrogen peroxide to clear out any debris in your ear. However, hydrogen peroxide should be avoided if you have an infected eardrum or tubes. Another way to remove water from your ear is to pull on your earlobe. You can do this by holding your earlobe with your thumb behind your ear. With your ear bent upwards, pull on the tip of your earlobe. You can also tilt your head to one side. That way, gravity will force the water out. Also, yawning or chewing will move the water to the outer ear. There are also swimming caps that can prevent water from entering your ear. You can also get custom-made swimmer plugs. Depending on your ear shape and size, your otolaryngologist can order one that will fit perfectly. 5. Cigarette smoking Smoking is associated with a higher risk of hearing loss. Cigarette smoke contains hundreds of toxic chemical compounds. The effects of cigarette smoking are primarily related to the number of cigarettes smoked and the total lifetime exposure to cigarette smoke. A large prospective cohort study of women in the United States has demonstrated a relationship between smoking and the risk of hearing loss. Compared with non-smokers, smokers are at increased risk of moderate to severe hearing loss. However, the mechanisms through which the adverse influence of cigarette smoke on hearing may occur are not fully understood. In order to better understand the mechanisms of the adverse influence of cigarette smoke, a study was conducted at the University of North Texas Hearing Clinic. This study evaluated the relationship between the level of cigarette smoke and auditory test measures, including central and peripheral auditory pathway measures. Behavioral and electrophysiologic test measures were administered to measure CO level. These measures were combined with other variables to predict the outcome measure. Using ordinary least squares estimation procedures, a predictive multiple linear regression model was selected to analyze the association between the auditory tests and the breath CO level. The results showed that the magnitude of the elevated risk was higher among past smokers than current smokers. For past smokers, the MVRR was 1.30 (1.09, 1.55). But the risk was reduced with a longer time since smoking cessation. Similarly, the MVRR was 1.21 for current smokers. There are many ways to quit smoking. Some of these include finding a quit program, medications, or individual counseling. You can also make your home and car smoke-free. Keeping your children away from the smoke reduces their chance of respiratory infections. Read Also: Seeking a Healthy Career: 10 Tempting Medical Careers to Check Out 8 Awesome Health Benefits Of Dark Chocolate Different Types Of Blood Circulation Exercise

The Health Benefits Of Swimming And Using Pools For Exercise

Swimming is one of the most popular fitness activities, which is especially pleasant during warm days. You can swim in the lake, sea, river, ocean and a swimming pool. Unfortunately, natural water reservoirs are not available for the whole year in each country, but a swimming pool exists almost in all cities and towns. In this article, we will review the benefits of swimming fitness and the benefits of health exercises in a swimming pool. We consider a swimming pool a good place for swimming, as you can work out there a whole year around, and the stability of fitness exercises is the main benefit of a swimming pool. 8 Health Benefits Of Swimming This article summarizes all information for average men or women without significant health disorders. In case of any, please visit your doctor before buying a ticket to a swimming pool. Below are the main benefits, but you can always find your reasons to exercise in cold water regularly. Possibility to exercise for all ages, gender, and physical abilities. There are no limitations for age or gender; everybody is welcome in the swimming pool. Even pregnant women can go for a swim; in the last trimester, swimming is recommended for moving a baby into the correct labor position. Also, swimming, and any other physical activity, help to maintain a constant weight. For people with physical disabilities, water gives them an opportunity to move freely without a wheelchair or crutches. Possibility to choose the exercise intensity. You can swim like a professional swimmer or slowly move your arms and legs. All activities in water help burn calories and engage all muscles to work. You can burn twice the amount of calories in one hour compared to walking at a moderate speed. This type of exercise is low-impact cardio; you can burn all calories and fat without significant heart load. The blood moves more efficiently, which means you also improve your heart muscles. Recommended for spine problems. Swimming exercises are the best healing method for many patients with back pain. Water supports all joints and the spine, relieving the pain; you can create new muscles to help you forget about spine pains. Surprisingly, you strengthen all muscles during swimming. Swimming is recommended for people with scoliosis as with the correct technique, your body stretches and obtains the correct and healthy position, creating new muscles. Healing of mental diseases increases Physical activities give endorphins which are happy hormones for our brain. Water, in addition to childhood for most people, is associated with fun and amusement. During swimming, you can also think calmly about all problems without interruptions. That is why you will be in an excellent mood after good swimming exercises. Improve body temperature regulations. The pool temperature is in the range of 78-82 F. There is a good way to fortify your body in winter in a swimming pool or in summer outdoors- your body adapts to the temperature below standard human temperature. Recommended for spine problems. Swimming exercises are the best healing method for many patients with back pain. Water supports all joints and the spine, relieving the pain; you can create new muscles to help you forget about spine pains. Surprisingly, you strengthen all muscles during swimming. Swimming is one of the beneficial exercises for scoliosis, as with the correct technique, your body stretches and obtains the correct and healthy position, creating new muscles. Strengthen the lungs. During swimming, you need to breathe rhythmically, making periodic arm and leg movements. Swimming trains the lungs as any other muscle. The warm and humid conditions are ideal for training people with asthma and other pulmonary diseases. The pool significantly increases their quality of life. Improve sleep habits. All exercise routines help to restart your internal clock and make it closer to your natural circadian rhythm. Swimming is an aerobic activity that helps to go to nap easier and sleep more deeply. In fact, there are endless benefits of swimming, but you already may understand that this activity is perfect for improving your health and mood. Unfortunately, natural reservoirs are not always available, so we recommend reading about the benefits of swimming pools. 5 Benefits Of Swimming Pools These benefits are related to commercial and residential pools. The only difference, residential pools should be cleaned by their owner (probably you); it may become additional exercise or pain. Unfortunately, for active swimming, the round residential pools are not suitable; it is recommended to have rectangular ones at least 15 m long. But you can give a good habit of swimming for kids, in this regard read bestway pool reviews. Almost all commercial pools are 25 m long and perfect for exercise. Anyway, the benefits are: Constant water and air temperature (for indoor pools) throughout the whole year. Clearwater without bacteria, algae, and other microorganisms. With proper cleaning and sanitation, the pool’s pH balance is safe for the human body. Also, the water is constantly filtered, and dangerous substances are accumulated in rivers or lakes. Safe swimming. The water in the pool is transparent and shallow; you immediately see all problems that happen with swimmers. Also, there are no streams that may be dangerous for kids, and people can’t swim well. Possibility to swim near the house. You can find the commercial pool nearby or buy your own. Easier ways to protect from unauthorized access without adults or professional supervision. We won’t say you should always choose pools, even in summer. But we just wanted to state that pools are for safe exercise, while rivers and lakes are for amusement and fun in summer only. Conclusion Swimming is a perfect exercise for people of all ages and physical conditions. Swimming pools allow regular exercise in a clean and safe environment all year around. No matter how you swim, freestyle, or butterfly, you will improve your health, build new muscles, and improve your lungs and heart. Also, you can improve coordination between various body parts and lose weight. Unfortunately, swimming is a demanding sport as you use your whole body to swim. Still, with hard work and regular training sessions, you can learn techniques of each swimming style and participate in competitions! Read Also: Renting A Villa In Malta With Private Pool All You Need To Know About Pool Maintenance Services

How to sleep better when you have cancer

Did you know that a poor sleeping schedule could increase your risk of cancer? It may be responsible for raising the risk of heart conditions, diabetes, and other major illnesses, as well as impair your immunity system. Experts have realized the importance of sleep in addressing these risks. They suggest that people should focus on improving the quality of their sleep to improve their lives. There are a large number of people who are already suffering from these conditions who may have trouble sleeping as a result. Do you have cancer? This guide can help you sleep better at night. How does cancer interfere with sleep? Cancer and cancer treatment can induce sleep problems even in people without a previous history of troubled sleep. You may be faced with excessive fatigue throughout the day from both your condition and treatment, which will impact your ability to get a full night's rest. Both could increase your risk of developing a sleep condition significantly. Sleep better for your better health habits during times of cancer. Cancer may cause both physical and emotional distress, which will affect your sleep. These can be very disruptive to your sleep patterns. The medication and treatment plans on offer for people with this condition will also cause sleep problems. Chemotherapy and radiation treatment will often carry side effects such as pain, night sweatband nausea, which will make it difficult to sleep at night. There are many secondary conditions that may cause other sleep complications that could arise from treatment. You may also face trouble sleeping from anemia and hypothyroidism. The most common sleep disorder among cancer patients is hypersomnia, which increases the urge to sleep throughout the day. Some symptoms of hypersomnia include having trouble staying awake, sleeping for more than 9 hours at a time and experiencing persistent sleepiness despite actually getting recommended amounts of sleep. It is linked with certain types of cancer, but may also be a result of treatment. About one-third of cancer patients experience the reverse condition, insomnia. Some of the symptoms of this include difficulty falling and staying asleep, feeling unrefreshed after a full period of sleep and regular early mornings. Most insomnia in cancer patients arises from chronic pain, but may also result from treatment. Cancer also increases the risk of disruptive sleep apnea and sleep-disordered breathing problems. It may be symptomized by poor concentration and memory levels, headaches, excessive sleepiness, chronic snoring, dry mouth, and sore throat, and decreased libido. How to sleep better when you have cancer Cancer can cause chronic pain, which will affect your sleep. You may also have a poor sleep schedule because of the treatment options which can take a toll on your body and mind. It is important that you maintain a healthy sleep routine to maximize your ability to get recommended amounts of rest every night. These are a few tips to help you sleep better when you are living with cancer. Restore balance to your sleep/wake rhythm You will be less likely to sleep if your circadian rhythm is compromised. Since it is affected by exposure to light, you can control your sleep/wake cycle by regulating your exposure to light. During the day, you should take in as much natural light as possible. At night, you should limit the amount of light to improve your ability to fall asleep. If you are facing increased fatigue from your treatment, you could consider healthy and energetic food options, as well as exercise, to build up your energy levels. This will help you stay up during the day and restore your natural rhythm for a better night. Maintain a sleep schedule You should limit your sleep to about the same length every night for consistency. Even on the weekends, you should only allow yourself at most one more hour in bed. This will help your brain build a positive association with your sleep environment, which will enable you to sleep and wake up within your schedule. You will be better able to get a good night's rest if you have an orderly schedule to help you out. Try out essential oils Essential oils are great for addressing chronic pain and managing other effects of cancer. You should incorporate these oils into your lifestyle because they can alleviate some of the effects of both your condition and treatment. Essential oils such as lavender can be applied topically as a form of aromatherapy to induce sleep. Other oils such as peppermint and tea tree oil offer anti-inflammatory effects. The pain reduction and effect on snoring will help you sleep without any disruptions. Limit blue light Blue light exposure can confuse your brain into tanking that it is still day time. It is emitted by phones, computers and other devices with a screen. It could affect your ability to fall asleep. You should make sure to have all these devices off at least 90minutes before bed to help you sleep better. Create a good sleeping environment Cancer patients need an uninterrupted night. However, this can be difficult because of the pain and other effects of treatment. You can improve your ability to get a full night’s rest by improving the level of comfort in your sleep environment. You could consider getting new mattresses, sheets and pillows to elevate your level of comfort. Visit bear mattress for a great selection of comfortable options. Aside from having comfortable sheets, warm pillows and a great mattress, you may also need to limit your exposure t light and noise to help you get to sleep. Some music could help you sleep better, but care must be taken to ensure it is not disruptive and accompanies your night. You could also consider natural and patterned sounds to help you fall asleep. Final word Sleep is restorative and beneficial for your health. It has been linked with an increased likelihood of successful cancer treatment; with people who sleep better likely to go into remission. Having as little as 6 hours or as much as 10 hours of sleep in a 24-hour period could negatively affect your ability to beat cancer. You need to develop and commit to a great sleeping schedule to increase you odds of survival. Sleep quality and hygiene could be just as integral to your survival as a good diet and treatment plan. Read Also: Can Breast Augmentation Cause Cancer? The Advantages And Disadvantages Of Non-Alcoholic Spirits

CE Mark for medical devices – An option or a necessity?

What is a CE Marking?

Why is CE Marking necessary?

How to obtain CE Marking for your product?

To sum it up

5 Types of Cancer Prominent in Women

5 Ways College Students Can Minimize Back to School Stress

Content Rally

Content Rally wrapped around an online publication where you can publish your own intellectuals. It is a publishing platform designed to make great stories by content creators. This is your era, your place to be online. So come forward share your views, thoughts and ideas via Content Rally.

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Ways To Balance Your Life With Healthy Hearing

The Health Benefits Of Swimming And Using Pools For Exercise

How to sleep better when you have cancer

CE Mark for medical devices – An option or a necessity?

What is a CE Marking?

Why is CE Marking necessary?

How to obtain CE Marking for your product?

To sum it up

Share this Article

5 Types of Cancer Prominent in Women

5 Ways College Students Can Minimize Back to School Stress

Content Rally wrapped around an online publication where you can publish your own intellectuals. It is a publishing platform designed to make great stories by content creators. This is your era, your place to be online. So come forward share your views, thoughts and ideas via Content Rally.

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Popular

Follow Us

Recent

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