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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Top Simple but Effective Ways To Get Your Eyebrows Thicker

Both women and girls always dream of having thicker, darker eyebrows. You can totally achieve your dream by growing your eyebrows through natural ways. Well-shaped eyebrows affect your appearance. A lot of people were treating their eyebrows in wrong ways due to threading, over plucking even waxing. Sometimes, eyebrow hair loss is the result of nutritional deficiencies, aging process as well as poor cosmetic application or even poor medical conditions such as eczema, alopecia areata or hypothyroidism. Such medical treatments as radiation, chemotherapy also trigger hair loss, including your eyebrow line. So basically thin eyebrows are just a result of hair loss. Fortunately, nowadays we invent a load of natural ways to thicker eyebrows. Let’s start with 5 amazing, natural ways to thicker eyebrows. Read also: Top 4 Natural Combination For You To Eliminate Blackheads (Infographics) How To Remove Acne Scars Naturally Tips To Lose Weight Naturally Castor oil grows thicker eyebrows: As we all know, the oil contains a load of rich nutrients for growing thicker eyebrows. Protein, fatty acids, vitamins and antioxidants, all of these compounds help foster the hair and nourish hair growth. Moreover, they are helpful in fighting any microorganisms, which hamper the eyebrow hair growing process. How to apply: Steep a cotton cloth in 100% pure castor oil and massage it gently on your eyebrows for 2 – 3 minutes. Let them absorb the oil for at least 30 minutes or leave it overnight. After 30 minutes or in the next morning, rinse it off with warm water and a mild cleanser. Keep doing this process daily, after a couple of weeks you will see the amazing results. Note: Do not use castor oil if it causes any burning or irritation. Coconut oil increases eyebrows hair’s density: Coconut oil is famous for its various proteins and nutrients such as vitamin E, iron. In order to grow more sensitive and more impressive eyebrows, coconut oil is the most preferable choice. On the other hand, coconut oil helps your eyebrows have a darker color. How to apply: Drop a little bit on your palm or your fingertips, apply the oil on your eyebrows. Gently massage it your eyebrows in order to increase blood circulation and help the hair to absorb the oil. Let it steep overnight. In the following morning, wash it off with lukewarm water. Repeat the process regularly in a few months and notice the changes of your eyebrows. Olive oil serves as a natural way: Similar to coconut oil, olive oil has become well known so far. Famous for being rich in vitamins, especially vitamin E, it can aid your eyebrow hair to grow thicker and faster. Furthermore, olive oil keeps your eyebrows dark-hued. How to apply: Put a few drops of olive oil on your palm, heat the oil by rubbing your hand together. Massage the warm oil on your eyebrows for about 5 minutes before going to sleep. Leave the oil overnight, in the next morning, wash it off with lukewarm water. On the other hand, if you don’t feel like directly applying the oil on your eyebrow hair, you can do it differently. Grab ½ teaspoon of olive oil and mix it with a little bit of honey. Heat the mixture with your hand by rubbing it then massage thoroughly on your eyebrow hair for a couple of minutes. Repeat the process by leaving it for 30 minutes and rinse off with lukewarm water. You can choose either of these two remedies once per day until you achieve the required results. Onion juice – a strong fighter: It may sound strange but it actually turns out very efficient. Onion juice provides sulfur, which boosts the making of collagen tissues. It is proved that collagen tissues are required for growing thicker eyebrows because it strengthens your eyebrow hair’s follicles. How to apply: Grind or smash an onion to extract the juice. Massage the juicy liquid on your eyebrows within 5 minutes. Permit it to dry itself then rinse off by using a mild cleanser along with cold water. Obey this treatment daily in a few weeks for the best result. Aloe vera sometimes presents as preferable choice: In addition to black eyes treatment, to grow thicker eyebrows, aloe vera is a good option. Aloe vera provides moisturizing properties as well as enzymes, both of which nourish the hair loss and help your hair to grow thicker and faster. Not only nourishing the hair, but aloe vera also soften the skin parts where you applied it. How to apply: - First, extract the gel and the flesh from an aloe vera leaf. Apply the gel on your eyebrows, let it absorb for 15 to 30 minutes till it dry. After that, rinse off the gel with lukewarm water. - Another choice is to buy the extracted gel in local drugs store. Mix the gel with coconut oil or use a few drops of honey to get the best result. After mixing, apply the mixture on your eyebrows then leave it for 30 minutes before washing off with warm water. Note: Strictly follow each one of these remedies every day in a couple of weeks. Read also: Top 5 Foods For Healthier And Thicker Hair

Try Out These Healthy Cake Options

Often cake lovers are asking about whether angel food cake is healthy or is carrot cake healthy. This is the self-evident thing which should come to every person’s mind who loves the sweet taste of cakes and also continuous about their fitness. So healthy cake exist or not? Be it weddings, anniversaries, baby showers, or farewells/graduations. Many of the brands are declaring the cake mix healthy, but is that really healthy? The list is endless. We have customized the flavor, which is perfect for Indian taste buds, and we also make fusion cakes. When it comes to healthy cakes, you can make them by using whole wheat or other grain flour. You can also consume palm sugar, jaggery, stevia, and fruit sugar to sweeten your cake. Avoid using sugar syrup. Try to use organic ingredients along with the Flourless cakes, which is also another option. Checkout Four Best Healthy Cake Options Here are some of the best healthy cake options you can send to your loved ones. Read on! 1. Healthy Multigrain Fiber Dry Cake Keeping yourself healthy doesn't always mean cutting things out of your diet; It also means including all the essential nutrients in your diet plan. So, the intake of multigrain fiber will be like a boost to your diet. This healthy multigrain fiber-rich healthy cake provides you with both health and taste. What more could a health lover ask for? Do you know that these multigrain fibers help in maintaining your weight, consequently reducing the risk of obesity? The cake also aids in digestion and lowers cholesterol levels. There is no doubt that brown moms will be most happy to see their kids serving this healthy dish. Why not send it as a birthday cake to your beloved? 2. Tea Cake Teacake is basically a no-frills, loaf-shaped cake with multiple possible flavors, which you can have with tea/coffee. They ideally have no icing or topping and are also served as warm slices. These healthy cakes are made from regular ingredients like butter, sweetener and flour, eggs, leavening agents, and flavorings of choice. But, traditionally, tea cake is from England and is a yeast-leavened sweet bread. 3. Sticky Cakes You must be searching for many healthy cake recipes but making a cake is not an easy task. While it can be baked using a variety of ingredients, some of our loved ones may be allergic to some of these food items, such as gluten and grains. Baking a cake without your favorite ingredients can seem a bit odd, but with others in mind and a few adjustments, you can make a delicious cake everyone will love equally. You can mix in sticky ingredients and chocolate. This is a great-looking and tasting cake! 4. Genoise Cake "Nothing expresses love for cake than a slice of Genoise cake. Beat some eggs, sugar, and flour, and let it rest, so it blooms with love and flavor. If you're not the kitchen type of person or the Genoise cake doesn't turn out the way you expected, then you can always find a wide range of genoise cakes in Chandigarh, Delhi, Bangalore, and all the major cities. Which cakes are healthy? So, we've cleared the air for you. Unlike any buttercream or fondant cakes, dry cakes are known as good for your body and health. Let's read about some health benefits of eating healthy cakes: A. Energy Source Sugar and flour are the two main ingredients of dry healthy cake recipes. These two ingredients are excellent sources of carbohydrates: Carbohydrates fuel the muscles, nervous system, and the entire body with energy. The fat present in the cake is also a good source of vitality. B. Strength Sweet confections like cakes supply proteins to the body. Cakes are baked with milk and eggs; Both are powerhouses of protein. Milk is rich in calcium which enhances the functioning of bones. Also, the dry cake is garnished with almonds and cashews, which strengthen the immune system, as nuts contain vitamins. C. Full Of Good Things Cakes are full of good things that provide enough vitamins to your body. For example, chocolate cake contains chocolate antioxidants. Vitamin-A carrot is found in carrot cake. Wherein Coffee and Walnut healthy Cake contain omega-3 oily walnuts. Some cake ingredients include what could have been more healthy ingredients found in diet foods. Related Resource: 8 Awesome Health Benefits Of Dark Chocolate D. Healthy Gut "Healthy Gut, Healthy You." Dry fruit cakes filled with fresh and ripe berries, cherries, apples, and pineapples are a storehouse of fiber. Foods with great fiber help keep the digestive system healthy. Dry, healthy carrot cakes also help in boosting digestion. Wrapping It Up: So, whenever your tastebuds crave cake, and your body warns you not to fall into the trap, you know how to silence the silence and order dry cake online. If you need more clarification about the market-available commercial-made cake ingredients, you can bake it at your home and enjoy the delicious taste of the healthy cake. Read Also: Which Edible is Right for You? 6 Delicious Cakes That You Must Try This Winter The Best Ways Cake Makers Can Pack Their Cakes

How To Encourage Your Teen Daughter To Seek Eating Disorder Treatment?

Over half of teen girls use behaviors to control their weight; according to NEDA, these behaviors can be risk factors for the development of an eating disorder. Eating disorders among young girls are quite common. If you are the parent of a teenage daughter who may have an eating disorder and feel she needs help, it can be a lonely experience. Teenagers who fear gaining weight can be adamant about not seeking the treatment they need. There are a few ways you, as a parent, can encourage your daughter to seek the best eating disorder treatment without forcing her into an uncomfortable situation. Different Ways To Conduct Eating Disorder Treatment There are multiple ways you can opt for eating the disorder treatment in your favor Work out the plans that can work well for you. Do not make your choices in grey that can have the potential to grow your appetite in the right direction. Identify the ways that can work well in your favor. 1. Approach Her Privately First Those who struggle with an eating disorder often feel shame and guilt about the issue. When beginning the conversation, one or both parents can speak to their daughter privately about the issue and why eating disorder treatment could be a positive step to recovery. 2. Let Her Know She's Not Alone Even though eating disorders are common among young ladies, many adolescents can feel alone in their eating disorders. DoSomething.org states 95 percent of those with an eating disorder are between the ages of 12 and 25. By showing your teen daughter statistical information about how many teens have dealt with eating disorders, sought eating disorder treatment, and recovered, she may feel encouraged to move forward in her recovery. 3. Try To Avoid Simplifying The Issue: If not fully understood, it can be easy to simplify the issue and tell a teen daughter to simply stop doing what they are doing or to feel as if treatment should be a simple process. Approaching a struggling teenager in this manner downplays the issue, which in turn can make a child feel even more shameful and guilty about the behavior they cannot control. The best eating disorder treatment programs approach adolescents using a multi-faceted therapeutic approach. It is important to convey to your child that recovery can be something only a professional eating disorder therapist can help them with. By letting them know how seriously you take the problem, they may begin to understand, or even mirror your concerns. 4. Accept A Potential Negative Reaction: The first few times you approach your teen daughter about her eating disorder, she may deny the issue or react in an angry or negative fashion. In order to understand these reactions, it is imperative to understand what your child is feeling about treatment. Many of the negative reactions and anger stem from fear of what will happen during eating disorder treatment. As difficult as it can be, it is critical to be accepting of these negative reactions. Acceptance and understanding do not mean you give up on encouraging treatment; it means you validate their concerns while maintaining your own. Meet any negativity with the reiteration of your concerns about the eating disorder, her health, and the importance of getting help. Continue to keep the dialogue. With proper therapy and treatment, 60 percent of people with an eating disorder achieve recovery. If you are struggling to talk to your teenage daughter about her eating disorder, reach out to us at Monte Nido. We are a multi-faceted treatment provider with multiple facilities dedicated to helping patients overcome eating disorders. Final Take Away Hence, these are some of the core factors that can work well in your favor and you have to make sure you do not fall back in your prices. Try to achieve your objectives in the best possible manner that can work well in your favor and in the best possible ways. Make your choices in the right direction before making the right decisions from all angles. Work out the plans that can help you to lead a steady life. Read Also: Tips To Lose Weight Naturally 10 Healthy Habits To Improve Your Health The Top 4 Health Benefits That You Can Get From Wall Soundproofing!

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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Top Simple but Effective Ways To Get Your Eyebrows Thicker

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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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