Obligations of manufacturers of medical devices.
The main obligation of a manufacturer of medical devices is to demonstrate compliance of the medical device with the legal requirements. Compliance can be demonstrated by carrying out the appropriate conformity assessment for the medical device.
Who is the manufacturer?
In accordance with the Medical Devices Regulation (EU) 2017/745, a manufacturer is defined as:
“A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.”
When a company A is selling medical devices onto the European market as an Own Brand Labeler, which means that company A is buying an already finished medical device from company B and places it on the European market under their own name (A), then company A is seen as the legal manufacturer. This means that an Own Brand Labeler has got the same obligations as the manufacturer as he is the legal manufacturer.
Besides the main obligation mentioned above, the manufacturer also has the following obligations:
- To establish, document, implement and maintain a system for risk management.
- Conduct a clinical evaluation of the medical device.
- Draw up the Technical Documentation and keeping it up to date.
- Drawing up the EU Declaration of Conformity and affixing the CE mark.
- Retention of documentation, which shall be kept available for the competent authorities for at least 10 years, 15 years for implantable devices.
- Ensuring that procedures are in place to keep series production in conformity with the legal requirements.
- Implement a post-market surveillance system an keep it up to date.
- Ensure that the device is accompanied by the appropriate information, e.g. instructions.
- Take necessary corrective actions when the manufacturer has reason to believe that a device that they have placed onto the European market or put into service is not in conformity with the legal requirements.
- Implement a system for the recording and reporting of incidents and field safety corrective actions.
- Have measures in place regarding financial coverage for potential liability as natural or legal persons may claim compensation for damage caused by a defective device.
It is important to keep in mind that the manufacturer is responsible for bringing a product onto the European market which is fully compliant with the legal requirements. Therefore, the manufacturer shall ensure that all obligations have been met.