Device manufacturers

'Manufacturer’ means an operator who manufactures a device or has a device manufactured, and markets that device under its name or trade mark.

See the definition of a manufacturer in the Regulations:

MDR: Article 2(30); IVDR: Article 2(23)

Manufacturers’ obligations

Before placing a medical device on the market or putting it into service, the device must comply with the applicable regulations. For example, manufactures must:

• demonstrate that the device's intended purpose complies with the definitions laid down in the Regulations;
• prepare the required documents to demonstrate that the device fulfils the general safety and performance requirements;
• include a clinical evaluation (MD) or performance evaluation (IVD) as part of the demonstration of compliance with the general safety and performance requirements; 
• have a system for recording and reporting of incidents and field safety corrective actions; and
• implement a post-market surveillance system.

Based on an appropriate conformity assessment, the manufacturer must draw up a declaration of conformity and affix a CE marking on the device. 

See the general obligations of manufacturers: MDR: Article 10, IVDR: Article 10

Manufacturers’ registration obligations

Medical device manufacturers must report their operator information and the manufactured devices to Eudamed. You can find more information on the “Registrations” page.