Responsibilities and Obligations of Medical Device Manufacturers under the MDR
Are you considering becoming a medical device manufacturer, but aren’t yet sure what responsibilities and obligations you’ll face?
Both before and after the placing on the market of medical devices, there are explicit requirements for the manufacturer, regulated by the Medical Devices Regulation (EU) 2017/745 (MDR). This new regulation also brings with ita whole range of new tasks and obligations for medical device manufacturers and other economic operators.
Therefore, a medical device manufacturer must first gain sufficient clarity regarding the relationship they have with other economic operators and the resulting responsibilities. Additionally, a manufacturer must address the regulatory requirements applicable to them in a timely manner before implementing them in their quality management system and medical devices.
In this training, you will learn what you need to pay attention to as a medical device manufacturer, which requirements you must meet, and what you need to consider regarding other economic operators such as “importers,” “distributors,” and “authorized representatives.”
- Content
- Difference between a physical manufacturer and a legal manufacturer
- Responsibilities and obligations of manufacturers
- Requirements for manufacturers prior to placing the device on the market
- Requirements for manufacturers after placing the device on the market
- Outsourcing of processes and related requirements for suppliers and subcontractors
- EUDAMED
- Requirements for a quality management system under the MDR and ISO 13485
- Responsible person under Article 15, MDR
- Other economic operators and their responsibilities
- Relevant laws, directives, standards, etc.
- Sanctions and liability
- Your Benefits
- You will learn about the tasks and obligations you must fulfill as a medical device manufacturer.
- You will learn about the rights and obligations of other economic operators with whom you must collaborate.
- You will receive guidance and suggested solutions to help you develop a successful plan for implementing the requirements.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices and those who wish to become manufacturers
- Employees in the Regulatory Affairs department
- Employees in the Quality Management department
- Employees who wish to familiarize themselves with manufacturers’ obligations
- Employees of regulatory authorities and Notified Bodies
