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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Dr. Maria Luong Discusses on Ways to Avoid Dental Problems by Keeping Dental Plaque and Tartar Away

Dental plaque and tartar are the main cause of tooth decay and tooth loss, but many people do not brush enough to keep them away. Even if you brush twice a day, you may be missing areas by using the wrong brushing technique or even the wrong toothbrush, causing almost as many problems as you fix. By controlling plaque and tartar properly, you can prevent tooth decay or tooth loss. Plaque is a sticky biofilm of bacteria that grows on your teeth, where it can destroy the enamel, leading to cavities and infections. Plaque is soft, making it relatively easy to remove at home with the right brushing and flossing techniques. However, within a few days, this plaque starts to harden into a calcified deposit known as tartar, which only a dental professional can remove. Without professional dental cleaning, tartar creates a perfect environment for more bacteria. This results in receding gums and bone loss as bacteria can grow below the gum line. Therefore, Dr. Maria Luong shares five ways to keep dental plaque and tartar from causing gum disease and tooth decay. Use the Right Toothbrush in the Right Way: Even if you already brush the recommended twice a day, you may still be missing areas, giving plaque time to attack your teeth and harden into tartar. To avoid this, make sure you're brushing with the right technique. Hold your toothbrush at a 45-degree angle towards your gums and lightly brush or massage your teeth and gum with short, circular strokes, as recommended by the American Dental Association (mouthhealthy.org/en/az-topics/b/brushing-your-teeth). Don't hold your toothbrush flat against your teeth while brushing it roughly over the tooth surface. This approach misses unwanted debris between your teeth while hurting your gums. Holding the brush at a 45-degree angle makes it easier for the bristles to move between teeth, and brushing along the gum line lets the bristles reach under the gums to remove food and plaque that's hiding. Make sure to use a soft toothbrush. By using a medium or firm bristled toothbrushes, it can risk damaging your enamel and can irritate your gums. Clean Between Your Teeth: Everyone hates flossing. It's awkward and doesn't do anything visible, so most people avoid it. However, if you are skipping on flossing, you risk getting cavities and infections in between your teeth, increasing damage and cost to repair your teeth. If you have trouble with flossing, consider using a water flosser or a floss pick to get at hard-to-reach areas of your mouth. You'll thank yourself when your dentist doesn't have to go drilling for cavities in your teeth. Get Regular Dental Cleanings: Even with perfect brushing and flossing techniques, everyone is going to miss a little bit of plaque that hardens into tartar. It is essential to see your dentist every six months or more so that they can clean away the hard tartar before it starts causing problems. It's less expensive to visit a dentist for a routine checkup and cleaning every six months than have your teeth destroyed by cavities because you avoided seeing a dentist. Rinsing with a Mouthwash: For a full-mouth clean, commercial mouthwash rinse will also help wash away bits of food, along with destroying bacteria. It's important as brushing and flossing. Mouthwash is effective in killing bacteria that cause decay and gum disease. Not all mouthwashes are created equal, so make sure what you're buying is approved by your local dental association, usually by looking for their association logo on the label. For instance, the American Dental Association has a seal of approval that proves the claims on the bottle (ada.org/en/member-center/oral-health-topics/mouth rinse). In addition, some dental associations, such as the Australian Dental Association, list approved mouthwashes on their website (ada.org/en/science-research/ada-seal-of-acceptance/ada-seal-products/product-category?supercategory=Mouthrinses). Reduce Sticky, Acidic and High-Carb Foods: Everyone knows that sugar i.e. sweets contribute to tooth decay, but that's only part of the story. Sugar leads to tooth decay because it provides an excellent high-energy food source for the bacteria that live in your mouth. This can produce acid that wears away at the protective enamel of your teeth. Bacteria can eat more than just sugar. Any high-carb food, from bread to French fries, is a perfect food for bacteria. Also, like the acid produced by bacteria, acidic foods and beverages can damage tooth enamel. These helpful hygiene habits do not mean you have to avoid these foods entirely but remember to brush your teeth relatively soon after eating sticky, acidic and high-carb foods, especially foods like potato chips that can get stuck on teeth. However, while it's good to brush soon after eating, wait at least 30 minutes to make sure the enamel hasn’t weakened from the acidic foods. Taking good care of your teeth may sometime seem like a hassle. By taking the time to brush and floss, and getting regular dental checkups, this will save you a lot of toothaches and expensive dental work in the future. “It is often those who avoid the dentist or have poor dental hygiene practices over long periods of time, end up having to deal with dental-related health problems – it is important to do your research and find a dentist you feel comfortable working with,” said Dr. Maria Luong. Read Also: 5 Dental Hygiene Tips For A Healthier Smile How To Choose The Best Fort Lauderdale Dental Office Dental Health: 6 Essential Dental Care Tips You Need To Know Essential Things To Consider Before Getting Dental Implants

Get Help With Your Addiction In Boulder

Addiction doesn’t just affect you. Addiction can affect your friends, family, and everyone else around you. Addiction can make it difficult for bystanders to be around you. You may find that you’re pushing the people you love away even if that’s not your goal. If you’re afraid of how addiction is hurting you and those you care about, then consider this a sign that you should reach out for help. Places like the Addiction Center of America or the Sunshine Behavioral Health in Boulder are great resources for you to explore. If you want to know how you can seek help for your addiction, then keep reading. Know that you have a problem Admitting to addiction can be really difficult for someone to do. It’s a brave thing to look within yourself and understand that you are a human being with flaws and are coping with a debilitating disease. No one wants to admit that they’re sick. But understanding that you suffer from substance abuse disorder can help you overcome your addiction. It’s the first step you take when you want to regain control over your life. See the signs within yourself If you suspect you have a problem with addiction, there are lots of resources to look at that will give you insights into the signs of substance abuse. You can’t admit that you have a problem if you aren’t aware of all the signs of alcohol or drug addiction. Some of the signs are You’re choosing drugs or alcohol over activities you used to love to do. These can include hobbies, social gatherings, or work events. You’re not taking care of yourself because you’re too high or drunk to You’re missing work due to substance abuse Your friends and family members have expressed concern over your symptoms You’re hiding things from those you love so they don’t see you using. You can’t stop using Talk to your friends or family about your addiction Opening up to those you trust most will help you air your concerns. While it may be embarrassing to talk about at first, expressing your desire to get help will give them notice too. They’ll be able to give you moral support by offering you encouragement or accompanying you to your program. It might make you feel better to clear the air and talk about your problem openly. Friends and loved ones can also hold you accountable for your actions. They can help monitor your journey to sobriety and offer an outside perspective you can’t see. You’ll grow closer during this process and hopefully come out stronger than ever. If you need help talking about addiction with your loved ones, click here. You might find it helpful to understand the best practices for starting the conversation. Reach out to your doctor Calling your doctor to talk about your addiction is another great way to find help here in Boulder. Your doctor will have the medical knowledge and resources to get you treatment as soon as possible. They’ll be able to get the ball rolling to heal your addiction. They’ll be able to assess whether or not you need inpatient care or detox. Detoxing from drugs and alcohol can be extremely dangerous when not under doctor supervision so please don’t try it alone. Call your doctor for help. If you don’t have a doctor, here are some quick tips for you to follow to find one. Know your options A lot of people think rehab centers demonize the disease or will get you in trouble. That’s not true at all. A rehab center practices confidentiality, so you don’t have to be afraid of others knowing about your addiction if you don’t want them to. And they have a lot of different treatment options for you to choose from. Some will give you the option of outpatient treatment. This isn’t always a good option for everyone but if it is for you, then you’ll be allowed to freely leave the center whenever you wish. This gives the patients the most control over their lives and allows for them to continue living normally while they seek treatment. There are also inpatient options, which a lot of doctors recommend if you’ve been addicted to something for a while or need to detox. This will ensure that you are safe and can’t go out and do drugs or alcohol too soon after treatment. While you aren’t allowed to leave on your own, this does allow you to shock your body out of its addictive patterns. It’s a very effective method for becoming sober. You can also seek therapy, go to group sessions, and practice religious exploration to combat your addiction. The most important thing to remember when choosing from your wide range of options is to pick something that is best for you. Understand how you can afford treatment Unfortunately, it’s true that drug or alcohol treatment centers can be extremely expensive. If you don’t have a plan in place before you enter one, you might find that you can’t even afford to continue. You need to know what options are available to you when it comes to paying for treatment. Most rehab centers, including the ones in Boulder, will take insurance to pay for treatment and most insurance companies provide plans that cover some or all of the cost of addiction treatment. If you don’t have insurance, government health has plans that cover some of the cost of treatment as well. In the event that you’re still finding it hard to come up with the pay, then don’t lose hope. Many rehab centers are flexible and will work with you to find a payment plan that works for your budget. There are also private and government-funded charities that will help cover the cost. There’s a lot you can do before you give up. Don’t give up! Addiction can be difficult to manage and everyone will have some sort of setback in the process. Just don’t give up! No matter the circumstances, you still deserve to be treated for your drug addiction and you still deserve to have a normal life. Research, talk to friends and family, and seek help. You’re not alone on this journey and there are thousands of people out there who have had success beating their addiction. Read Also: How To Live Stress-Free Planning a Family Vacation as the Kids Grow Up Make Your Vacation Less Stressful With the Following Tricks

How To Achieve Mastery Of Biochemistry Concepts?

Biochemistry reflects on the chemical compositions of living organisms. If in a science class one has encountered statements like the chemical composition of blood glucose is C6H12O6, then this lesson is part of biochemistry research that has found its way to textbooks. Biochemistry also deals with chemical interactions between living cells. For instance, once we eat, the process of digestion that releases energy in the form of ATP and the chemical reaction involved in these metabolic activities are part of biochemistry. The signals released by the brain in response to pain, how oxygen is used by blood cells, and the entire chemical process involved at the molecular level is studied as part of the biochemistry discipline. A biochemistry course can be taken both as a specialization or an interdisciplinary course along with a related major or minor for challenging career prospects in life sciences. Interested students can check out this biochemistry course. Scope And Uses Of Biochemistry Biochemists hold numerous positions not just in the direct or ancillary healthcare sector but also in any field that involves food and nutrition. Here are a few areas where biochemistry is used: A. Nutritional science The molecules like amino acids, lipids, fats, carbohydrates, and fiber constitute the macros of a balanced healthy diet. Biochemistry in food and nutrition deals with the process of generation and maintenance of the essential macros and glucose levels in a body. Any tipping in the readings will be the result of the body's chemical response to any underlying disease condition. B. Genetic engineering Genetic engineering is technically a branch of biotechnology. However, to understand DNA sequencing, chemical composition is necessary information. And hence biochemistry becomes an interrelated discipline for genetic engineering. Biotech is widely used in understanding pathological specimens of microbes, and human, veterinary, and plant genes to help in combating diseases, creating resistant varieties of bloodlines in animal husbandry, and disease-resistant variants of plants. C. Medicine Pharmacological advances in new drug formulations, the development of vaccines, immunology, and pathology are some areas where biochemistry is widely used. Only through biochemistry, the rollout of Covid vaccine was possible. Tips For Preparing For Biochemistry Biochemistry is a vast subject that deals with humans, animals, and plants. It has other sub-categories like structural biochemistry, enzymology, xenobiotics, and organic and molecular biochemistry. Considering the numerous topics, although the subject is interesting, studying for coursework can be daunting. But with a little bit of planning and learning hacks, preparing for biochemistry lessons can seem like a breeze for students. Here are tips to prepare for biochemistry coursework: 1. Memorize The chemical sequence Biochemistry is one of the least-liked subjects by many because of the many chain reactions and pathways that one needs to remember. The only way one can remember these chemical reactions is by logically grasping them, and then writing them down 2-3 times to memorize them. Once you have understood and memorized it correctly, write it backward. This step seals the content in your memory for a long time. 2. Revise important topics Biochemistry is easy to forget a subject if you have not grasped the concept and memorized it. Topics related to organic biochemistry, lipid metabolism, amino acids secretion, enzymes secretion by glands like the pituitary and liver, the pentose phosphate pathway, and nucleotides need to be revised through notes revision, flashcards, and practice quizzes. 3. Study groups Divide the biochemistry topics among members of study groups to make notes. In this manner, all the important topics can be revised easily by dividing the work related to notes and crucial points that form the framework of the lesson 4. Illustrate Biochemistry is easy to remember when you use imagination and draw the reactions in a fun and easy-to-understand manner. You can always give character names to any of the molecules that are both easy to remember and relatable. 5. Focus on an essential topic Divide the topics into the most repetitive and course-wise imperative ones. Divide your attention in an 80:20 ratio and give more importance to the core topics. In this manner, the regularly difficult topics are covered and repeated. Twenty percent dedicated to other least important topics can be revised once. This way is ideal when trying to fit in a lot of work within a short timeframe. For instance, you can give more time to topics on metabolic and organic chemistry, enzymes, and pathways. 6. Comprehend Biochemistry is a science subject and rote memorization alone can never work. The only way to retain it for a longer time comes from grasping the concepts and even memorizing them. If you can practice explaining the concepts to a five-year-old by following the Feynman technique, then the chances of you understanding the concepts are more. 7. Biochemistry terminology All the terms used in this subject are different and some concepts will be completely new to you. Enzymes have suffixes like lyases, hydrogenases, oxidases, etc. A grasp on these terms by memorizing through mapping can help a student fare better 8. Structural biochemistry Learning the chemical structure of molecules of chlorophyll, glucose, enzymes, amino acids, triglycerides and all other compounds within a living being will help biochemistry enthusiasts in their research as well 9. Organize study time As the syllabus of biochemistry is an expanse, allotting a specific time and sticking to the schedule will help individuals gain confidence and have enough time to revise important topics before tests. 10. Take short breaks When reading long topics and sequentially memorizing them, it is essential to take short breaks that can help a person rejuvenate and remember the lesson. Conclusion: Biochemistry is an important subject in medical school and some of the stem sciences. It is an essential subject in life science. There are a wide array of jobs that can be obtained with an education in biochemistry. It is an important part of the med school program as well. Anyone interested in studying biochemistry can explore online Medtech platforms that will aid in improving the grasp through multiple immersive topics with animated illustrations. Read Also: Creating Health Advice Resources? Foreign Language Versions Are Essential How Can Healthcare Staffing Benefit You? The Diet To Follow For A Healthy Gut

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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Dr. Maria Luong Discusses on Ways to Avoid Dental Problems by Keeping Dental Plaque and Tartar Away

Get Help With Your Addiction In Boulder

How To Achieve Mastery Of Biochemistry Concepts?

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

Related