IVDR
IVDR
The European Union’s Regulation (EU) 2017/746, known as the In Vitro Diagnostic Medical Devices Regulation (IVDR), governs the introduction of in vitro diagnostic medical devices (IVD) onto the market and their deployment.
IVDR implementation comes along with a number of changes in the way manufacturing companies from the Life Science industry operate. The new law forces:
- Changes in the production processes
- Structural and staff transformations
- Updating technical and quality documentation
- Qualification of laboratory rooms and Equipment
- Validation of manufacturing, packaging, transport, and cleaning processes
What does IVDR change?
- The new regulation places greater emphasis on a life-cycle approach to safety, supported by clinical data.
- It increases transparency by making information on in vitro diagnostic medical devices public. The data will be collected and published by the European Database on Medical Devices (EUDAMED).
- It clarifies the requirements for clinical evidence. Innovative devices of the highest risk class (D) are now required to be evaluated by independent experts.
- It defines the new obligations of business entities: manufacturers, representatives, importers, and distributors. It introduces unique device identification (UDI) codes for each in vitro diagnostic medical device, which allows product identification and improves safety associated with its market launch
- It changes the risk classification of medical devices (from A to D), imposes more strict requirements, and empowers authorities to perform controls
IVDR implementation
Neglecting the implementation may even stop the production or plant operation, and lead to significant financial loss.
Therefore, you have to get prepared for IVDR implementation and learn how to carry it out effectively.
IVDR implementation is a comprehensive process covering a wide range of activities
(preparing documents, procedures, instructions, validation, qualification, and training). As part of IVDR implementation, it may be necessary to change or adapt the company’s quality assurance system and update documentation.
The advantages of implementing IVDR in the outsourcing model are:
Access to Specialized Expertise
Outsourcing provides access to specialized skills and resources crucial for meeting IVDR compliance standards.
Cost Efficiency
Outsourcing can offer cost savings compared to developing internal capabilities for IVDR compliance.
Flexibility and Scalability
Outsourcing allows for flexible resource allocation, enabling companies to adjust resources according to project needs.
Core Focus
By outsourcing IVDR implementation, companies can focus on core functions while leaving regulatory compliance tasks to external experts.
Faster Time to Market
Partnering with experienced outsourcing providers can speed up the IVDR implementation process, facilitating quicker product development and market entry.
Risk Management
Working with established outsourcing partners can help mitigate risks associated with IVDR compliance, leveraging their expertise to navigate regulatory challenges effectively.
Ongoing Support
Outsourcing providers can offer continuous support and maintenance services, ensuring sustained compliance with evolving IVDR regulations.