There are things that we often overlook, and it’s important to understand their meaning. The CE mark is the European equivalent of the FDA approval in the USA. This shows the importance of this mark, which is much more than just a mark. It’s a symbol of trust, reliability, and safety that entire Europe relies on. The CE mark is an essential certification for any European device manufacturer due to its overwhelming importance for marketing your products in the EU.
We’ll be looking at some of the things that you should know, and even if you already know what it is, you’ll discover some uncommon facts which are very important. So let’s get to it and find out more about this coveted certification.
1. What a CE Marking is
The CE mark, also known as “Conformité Européenne” is French for “European Conformity”. This mark is acceptable in all the countries of the European Union and is often found on different products like toys, medical devices, electrical equipment, technical devices, and much more. This mark is a symbol of the fact that any product stamped with this mark is certified to be safe for personal health and the environment. It’s a common standard for all the companies and assures the consumer that the manufacturing company is accountable for all the procedures laid out for obtaining this mark.
2. How You Can Obtain It
If you want to obtain a CE mark for your medical devices then you have to comply with the European Commission Regulation No. 2017/745 which is also known as the Medical Devices Regulation. To do that, you have to make a technical report that can prove the claims of your product meeting the laid down requirements. You have to also prepare a CER, also known as the clinical evaluation requirements to get the medical devices approved for a CE mark certification. There are many other requirements that you must go through before applying for the CE mark, or else you won’t be successful in getting your application approved.
3. Legality of CE Marking
There are numerous reasons for obtaining a CE mark other than the simple fact that it’ll allow you to market your products to one of the largest markets in the world. It’s a legal obligation on you to get your medical devices certified or else you might have to face a penalty for your actions. You’re also bound to get your devices certified and equipped with a CE mark because of the EU legislation that mandates you to do so. If you choose to sell the products without a CE mark then it’ll be considered an economic offense throughout the entire EU and different member states have different measures to deal with such an offense. So, to be on the safe side, you should obtain a CE mark for your product, and it’ll ensure that you don’t face any troubles later on.
4. Other Benefits
The CE mark is a very versatile tool and there are more than a few benefits to this marking. The CE mark will gain your product the trust and loyalty of your customers, who’ll be reassured due to the presence of this mark. It’s also known as the “Passport to EU” because of its ability to allow your products into the borders of all the members of the EU. People are more likely to buy a product that has the CE marking on it as compared to the products which don’t have any markings at all. The presence of the CE mark will make the consumers feel more responsible towards the environment, and it’ll also provide them peace of mind about the product being non-toxic.
5. Associated Fees
If you decide to carry out the conformity assessment of your product from your own end, then you won’t have to pay any fees whatsoever. However, you’ll have to pay for the services of a notified body if you choose them to conduct the assessment for you.
These are some of the basic things that you should know about the renowned CE mark. It’s a very important tool in your arsenal as it helps the manufacturers prove that their products are safe and meet certain quality standards. Obtaining a CE mark will give you an edge over your competitors, which will help you sell more and gain more profits. Since the EU is such a huge market, it becomes essential for any company to market their products there and utilize the benefits of a prosperous consumer base.