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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3 Things to Know About Long-Term VOC Exposure

Volatile organic compounds, or VOCs, are one of the leading causes of air pollution. They pose an immediate environmental risk to the average individual. VOCs can be both natural and manufactured. They are dangerous because of their volatility, which means the toxins evaporate into the air at room temperature. VOCs are released into the indoor air that we breathe and can cause exposure. Beyond the danger of their short- and long-term effects, VOCs are particularly hazardous because most of the time, you cannot see or smell them. Learn the following about long-term exposure to VOCs and how you can reduce your risk. You Can Be Exposed Through Everyday Activity: Individuals can be exposed to VOCs in a variety of ways. Smoking cigarettes or being in the presence of secondhand smoke, using common household cleaners, working with commercial building and crafting chemicals, or using products that contain formaldehyde or benzene all increase your exposure to VOCs. There are two ways to be exposed to VOCs. First, you can become exposed by inhaling air that contains volatile compounds. In addition, you can become exposed when your skin comes into contact with products that contain and release VOCs. Formaldehyde is one of the largest contributors to environmental pollution via VOCs because of the significant amount of residential, commercial, and personal products that contain it. Long-Term Exposure Can Cause Serious Issues: The danger of VOC exposure varies depending on the amount of VOCs in the air, the length of time you have been exposed, and how often you are exposed to it. Short-range exposure can garner a variety of symptoms, including headaches, dizziness, irritation to the eyes, and memory issues. Being exposed to VOCs for longer periods can induce more serious symptoms. They can include consistent eyes, nose, and throat irritation; nausea; loss of coordination; prolonged periods of fatigue; damage to your liver, kidneys, and central nervous system; and in some cases, even cancer. It's Possible to Reduce Your Risk: To limit your risk of VOC exposure, it is advised to reduce the amount of time you spend breathing in air that contains VOCs. Likewise, limit the time you spend using chemicals that contain and release VOCs, such as household cleaners or commercial crafting supplies. Whenever possible, buy and use naturally sourced cleaning supplies, cosmetics, or other personal items. Taking measures to improve air quality can also help to reduce symptoms and any long-term damage. The installation of features such as air-cleaning ventilation systems can improve your air quality. These systems help take out the air that contains VOCs inside your home and replace it with preconditioned fresh air. Volatile organic compounds are an immediate threat and can cause harmful long-term symptoms. However, there are ways you can protect your health. Start by limiting your exposure to air that contains VOCs. In addition, install ventilation systems to replace contaminated air inside your home. It doesn't take a lot to make a difference, but it can save you from some serious health concerns in the long run. Read Also: Are X-Rays Dangerous? American Healthcare And Its Woes Can Vaping Really Help You Kick Your Smoking Habit? As The Years Go By: Top 3 Challenges Faced By The Aging Population

How to Solve Some Problems of The Vapes

There are many reasons for the short circuit of the atomizer. If it is short-circuited protection, there is no danger. If the mechanical mod may cause the battery to explode, the short circuit of the atomizer is not a particularly serious problem, but it still needs to be taken seriously. The cause of the atomizer short circuit and its solution. After cleaning the atomizer, it will be installed and used without causing a short circuit. This situation is very simple, just remember to wipe dry after cleaning the atomizer, it is best not to use it immediately. The bottom electrode is low, and the top of the electrode of the host is not touched, resulting in a short circuit. Try to slightly rotate the electrode screw on the bottom of the atomizer a little. Check if the heating wire lock screw is tightened and re-wire the wire if necessary. Check if the bottom electrode is too tight, screw it out, and replace it with another electrode screw if necessary. How to avoid short circuit of a mechanical mod? Always check the resistance and short circuit of the atomizer. Unlike general-purpose vapes, mechanical mods can be ignited even when the atomizer has been short-circuited. Here, the resistance of the short circuit refers to zero or near zero, but most tanks do not let the resistance be less than 1.5 ohms, which ensures that the battery is not overstressed. When using a new atomizer, be sure to check the atomizer resistance and confirm that there is no abnormality before screwing it onto the mechanical battery compartment. If you use an RBA, don't let the resistance be too low, because too low a resistance will make the battery pressure too high. It is best to control the resistance between 2.4 and 3.0 ohms at the beginning to ensure safety. Although the atomizer is not so easy to short-circuit, it is best to use a multimeter to test. The specific test method is this, remove the battery, connect the battery compartment and the atomizer, put one probe of the multimeter to the positive pole of the battery compartment, and the other probe touches the surface of the battery compartment. If the multimeter shows a non-zero resistance value, it means that there is a current, so there must be a short circuit. When testing the resistor with a multimeter, be aware that the multimeter's leads may also generate resistance. We have seen some very cheap multimeters with lead resistances even higher than 0.6 ohms. The lead resistance can be displayed by touching the two probes of the multimeter. This value needs to be subtracted when testing the atomizer to get the true resistance value. For example, if you measure the resistance of the atomizer to be 2 ohms, if the lead resistance is 0.6 ohms, then the true resistance is only 1.4 ohms. In short, the atomizer is short-circuited, don't worry, think about the above problems can be solved. After a period of use, the atomizer needs to be cleaned regularly. The inside of the atomizer will be stained with some non-volatile liquid condensate. If it accumulates too much, it will affect the atomization effect of the atomizer, which will lead to the taste odor. In addition, when replacing different flavors of smoke oil, it is also necessary to clean the atomizer beforehand to avoid affecting the taste experience. The daily cleaning frequency of the atomizer is recommended to be cleaned once a week. The following is the atomizer cleaning method 1. Hot water After the residual oil in the atomizer flows out, pour the appropriate amount of hot water, shake gently for 1-2 minutes, wait for the dirt inside to dissolve in the hot water, then slowly pour the water out to dry. Or use a hairdryer to quickly dry it. This method is simple and easy to clean, but there are still residual odors that affect the taste. 2. Vinegar The atomizer is placed in clear water mixed with vinegar and then cooked. After heating for about 10 minutes, then wash it with water and then dry it. Cleaning the atomizer with vinegar is still good. 3. Cola Soaking the atomizer in a cola drink takes about 24 hours. After taking out, the water is washed and finally blown dry. This method takes a long time and the effect is not very satisfactory. It is not recommended to use it frequently. 4. Vodka. Blow the atomizer, pour the appropriate amount of vodka, seal the atomizer mouth with your fingers, and gently shake for one to two minutes and then pour off. Rinse off with hot water and let it dry. This is a more effective method to substantially eliminate the dirt and taste of the inner wall of the atomizer. Read Also: Vaping Is Fighting The Deadly Consumption Of Nicotine 7 Things You Should Know About Owning A Vape

10 Health Problems Eased by Yoga

Yoga originated over 4,000 years ago as a spiritual practice. Over time, however, health and wellness experts have found that there are many physical benefits as well. Now, yoga is as much of physical practice as it is a spiritual one. While yoga is not a substitute for traditional healthcare, as a compliment, it can help ease symptoms associated with a variety of health problems. According to the National Center for Complementary and Integrative Health (NCCIH), people are increasingly using yoga to relieve pain, anxiety, stress, and to improve their overall health. So what are the health problems that yoga can help with? Put together by a Portland yoga studio, let’s take a look at 10 health conditions that researchers show yoga can ease. 10 Health Problems Eased by Yoga 1. Chronic Stress: Practicing yoga may be helpful in relieving chronic stress. A regular yoga practice can reduce your stress response and provide options for self-soothing and better management of stress. 2. Anxiety: A study in the Journal of Preventative Medicine shows that yoga can help reduce the symptoms of anxiety. When used alongside other treatment methods, it is helpful in reducing anxiety and helping patients manage their symptoms. 3. Heart Health: Practicing yoga has been shown in studies to reduce the risk of heart disease. When practiced as part of an overall healthy lifestyle, yoga can be used to improve heart health and reduce the risk of dangerous diseases. 4. Brain Health: Practicing yoga could be beneficial in improving brain health. Researchers report that people who practiced yoga for 14 years had thicker brain tissue in the areas responsible for memory and attention than their peers. 5. Chronic Back Pain: People who suffer from chronic back pain may find some relief through a regular yoga practice. Research shows that yoga can reduce back pain and improve mental health in people with chronic pain. Researchers note that yoga and other stretching exercises are both beneficial in this way. 6. Improve Balance: Yoga is a great way to improve balance. This is important, especially for older adults. Some studies suggest that a regular yoga practice can reduce the risk of falls in older adults. This is a promising option for older adults to get low-impact and meaningful exercise. 7. Thyroid Function: Research in Medical News Today suggests that stress can lead to improper thyroid function. Fortunately, practicing yoga can reduce stress, which in turn, helps improve thyroid function. Research is ongoing, but studies suggest yoga could potentially help ease medical conditions like hypo-and hyperthyroidism. 8. Diabetes: Research in the Journal of Clinical and Diagnostic Research shows that a regular yoga practice can reduce blood glucose (blood sugar) levels. For people with Type 2 diabetes, not only could they lower their glucose levels naturally, but they also may be slowing down progression of the disease. 9. Atrial Fibrillation: Atrial fibrillation is a heart condition where the upper chambers of the heart don’t contract as they should. This can cause symptoms like dizziness, palpitations, and shortness of breath. It also increases the risk of heart failure. Research shows, however, that practicing yoga at least twice weekly can improve symptoms. When added as part of a regular treatment plan, yoga can help improve heart function and manage stress. 10. Boost Immune System: Health conditions related to chronic stress account for 60 to 80 percent of all visits to primary care doctors. Several studies now show that practicing yoga can reduce stress, and as a result, also reduce the symptoms caused by it. Chronic stress and illness weaken the immune system, but a regular yoga practice could be the key to naturally averting some of these illnesses. As you can see, there are many benefits to practicing yoga. The next time you talk to your doctor, ask him or her about the possible benefits of adding yoga to your treatment plan. Is Yoga Enough Exercise? Yoga can be enough of an exercise, especially if you're looking to improve flexibility, balance, and strength. In fact, if you do it right, it helps build core muscles and tones the body while promoting relaxation. But if you have intense cardio or muscle-building goals, it might not be enough. In that case, coupling yoga with other cardio or muscle building exercises is the best way to go. Is 10 Minutes of Yoga Good? First, you must understand that building a yoga routine takes time. Therefore, you should begin with a ten-minute routine. So, yes, even if you only have 10 minutes, yoga can help you feel better, more flexible, and less stressed. It’s perfect for a midday break or to start your day on the right foot. Regular work in small doses adds up to big improvement. Yoga After Delivery? Yes, you can.... but....not right away! On the safe side we recommend waiting at least a few weeks after delivery to start yoga but it depends on the recovery. Post delivery yoga should focus on breathing & stretching lightly. Do not try to move your body too much! Yes, you won't be too flexible at that time (even if you do yoga beforehand). It is normal! Note: Please consult your doctor if your body is ready for physical activity & then only get back to regular yoga. What Yoga is Appropriate When Pregnant? Prenatal yoga is a type of yoga class that is specifically designed for pregnant women. Prenatal yoga classes are usually gentle and focus on breathing and relaxation techniques. If you’re pregnant, use our prenatal directory to find a prenatal yoga, then drop into a class. Finally: Can Yoga Help with Anxiety? Yes, yoga is great for anxiety! Yoga uses conscious breathing and movement to induce relaxation and calm the mind. Over time, this practice lowers stress hormones—making it an effective natural treatment for anxiety disorders. But both yoga and other forms of treatment are needed for optimal mental health benefits. However, over time, you must build consistency. You cannot do yoga occasionally for a month and expect a change. If you want to see some difference, whether physical or mental, you will have to keep going. Read Also: How To Live Stress-Free Effects of Anxiety on Heart Disease 5 Ways To Get Healthier In The New Year Some Famous People Who Have Battled with Depression 10 Tips on How to Ditch the Stress and Start Living a Peaceful Life

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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3 Things to Know About Long-Term VOC Exposure

How to Solve Some Problems of The Vapes

10 Health Problems Eased by Yoga

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.

Leave a Reply

Popular

Follow Us

Recent

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