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:
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.
Read more
- Flowchart of the applicability of the transitional periods
- Questions and Answers document concerning the transitional periods and the removal of 'sell off' date
- Factsheet for Manufacturers of medical devices
- MDCG 2019-15 rev.1, Guidance noter for manufacturers of class I medical devices
- Factsheet for Class I Medical Devices
- Factsheet for Manufacturers of Implantable Medical Devices
- Factsheet for Manufacturers of in vitro diagnostic medical devices
- Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices
- Implementation Model for in vitro diagnostic medical devices Regulation Step by Step Guide
- Implementation Model for medical devices Regulation Step by Step Guide
- Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
- Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
- Unique Device Identification (UDI) System
- UDI Helpdesk
- New EU Rules to Ensure Safety of Medical Devices
- New EU rules to ensure safety of medical devices - European Commision - Fact Sheet
- Exhaustive list of requirements for manufacturers of medical devices
- MDCG endorsed documents and other guidance
- Factsheet for Manufacturers of Implantable Medical Devices