In an era where technology and science are advancing rapidly and continuously, one of the most important factors when choosing products, medications, or medical equipment is the safety standards of those products. Today, there are numerous regulations and standards in place to ensure product safety and quality.
For example, in Thailand, we have the FDA (อย.) and TISI (มอก.) as indicators that products meet safety standards and are ready to be distributed to consumers. However, in this article, we will focus on the CE symbol and CE Marking in terms of safety — something that many people may not yet be familiar with or fully understand. Let’s explain it clearly in this article.
First of all, let us begin by saying that you can usually spot the CE mark on a specific part of the product. The CE Mark or CE Marking is typically found on the label of the product, often located at the lower corner of the label. Now that you know where to find it, let’s move on and understand what CE actually means.
What is CE Marking?
When you hear the term CE Mark, you might wonder what it means and how it relates to the safety standards of various products and medical items.
In the European Union (EU), spotting the CE Mark on these products is like seeing a symbol of quality assurance—confirming that the item meets the required standards and criteria set forth by the EU.
This standard represents the most essential procedures in the manufacturing process, testing, and precise inspection to ensure that the product meets the required quality and safety standards. These standards are used in many countries around the world and serve as a certification that the product or medication ranks among the top in terms of safety and high performance.
The CE marking confirms that a product is authorized to be imported into the European Union and can move freely among over 30 countries in the European Economic Area. If it is found that a product that requires CE marking does not display it, the manufacturer or distributor may face fines and be ordered to recall the product, which can result in extremely high costs. Therefore, it is essential to comply with the specified requirements correctly.
What is the Medical CE Mark?
CE Mark for Medical Devices complies with Directive 93/42/EEC, which is a law of the European Union agreed upon by 27 member countries to serve as a guideline for demonstrating the safety of medical device products. Today, not only the 27 European countries, but also countries in other continents recognize and adopt this directive as a standard guideline.
CE Mark Number for Medical Devices
- Active Implantable Medical Devices (AIMDD) 90/385/EEC: Medical devices implanted inside the body with electrical power.
- Medical Devices Directive (MDD) 93/42/EEC: General medical devices and instruments.
- In Vitro Diagnostics Medical Devices Directive (IVDMDD) 98/79/EC: Medical devices related to diagnostics, such as test tubes and laboratory equipment.
How important is CE Marking in the medical field?
For the medical field, the safety and standards of products and medications are extremely important. Low-quality medical products can negatively impact the health and safety of users. Using products that meet safety standards ensures accurate medical record-keeping, proper functioning of devices and medications, and safer patient care overall.
To present high-quality and safe medical products, the CE Mark serves as a key indicator for verifying the safety and effectiveness of these products. You can check for the CE Mark on the products and medications you use to ensure that their safety and compliance have been strictly inspected.
A concise and easy-to-understand summary of the importance of the CE mark
- Certifies that the product complies with the EC directive
- Reduces multiple and repetitive inspections from customers within the EU
- Demonstrates compliance with the laws of the European Union (EU) and the European Free Trade Area (EFTA)
- Ensures the product can enter the EU market
- Guarantees product safety for customers
- Ensures public safety
- Builds product credibility
- Improves customer satisfaction
And CE Mark is another important safety standard that The Vogue Clinic pays great attention to when selecting medical products, devices, and medications. This ensures that everyone who comes to The Vogue Clinic receives beauty and good health without unnecessary risks, as Dr. Beam, our Medical Director, always reminds everyone.
