The CE (Conformité Européenne) mark is affixed on products to indicate that the product bearing the mark conforms to all the requirements for safety, health, environment, and consumer protection within the European Union. Products that are required to bear the CE mark must have the mark affixed before they are distributed and placed on the market.

Medical devices are one of the products that are required to bear the CE mark. This has been specifically regulated in Regulation 2017/745 on Medical Devices and Regulation 2017/746 on In Vitro Diagnostic Medical Devices

The CE mark will be issued by Notified Bodies or through self-assessment, depending on the type of your medical device.

Brilitas understands the regulations and has a strong foundation in the European Union market to be able to advise and support you in implementing CE marking for your medical devices.

For Medical Devices and In Vitro Diagnostic Medical Devices, they must fully comply with the general requirements of Regulation 2017/745 and Regulation 2017/746, including:

• Requirements for safety and performance

• Requirements for design and manufacture

• Requirements related to information provided with the device.

In addition, depending on the type of medical device, there may be different standards to meet. Only after the product complies with all relevant standards can Notified Bodies issue certification (except for MDR Class I) and you can begin to affix the CE mark to your product.

To begin the process of affixing the CE mark to a medical device, we must first classify the product to determine the appropriate implementation process. Generally, the implementation sequence still follows the following steps:

• Step 1. Determine the product’s compliance with the general requirements of the EU Regulation.
  

• Step 2. Identify the applicable standards for the product.
  

• Step 3. Notified Bodies conduct assessments and checks on the product’s compliance with the standards of the European Union.
  

• Step 4. Notified Bodies issue certificates of compliance with the standards.
  

• Step 5. The manufacturer affixes the CE mark.
  

With its headquarters located in Estonia – one of the member countries of the European Union, we have the capability to advise and assist you in obtaining your CE certification. Choosing us, you will experience and receive the following:

• Product classification support
  

• Assistance in identifying applicable standards for your product and related testing requirements
  

• Evaluation of your file or assistance in preparing technical documentation
  

• Review of labeling and product marking to ensure compliance with essential requirements
  

• Preparation of clinical evaluation reports
  

We will support you throughout the process until you obtain certification. With all our dedication to the job, we always want to stand by your side and advise you anytime.