The European Union (EU) is a highly regulated market, especially when it comes to medical products and equipment, such as those used in dentistry. Within this context, the CE mark (Conformité Européenne) is a mandatory label that certifies that a product meets the safety, health, and environmental protection standards set by EU legislation.

This applies to a wide range of products, including medical devices such as dental implants.

The regulation requires that products undergo a rigorous clinical evaluation, especially if they are new or have an innovative design. Manufacturers must provide evidence that their products work as promised and do not pose risks to patients.

EU countries have easier access to technological innovations and new dental equipment. The CE mark is mandatory for the use of products and equipment in Europe.

The sale of implants in Europe is strictly regulated by the European Medical Device Regulation, which requires CE certification, clinical testing, and continuous monitoring to ensure safety and effectiveness.