A major change in the implementation of the new IVDR is the requirement for the registration of economic operators in the new European database for medical devices (EUDAMED). The economic operators are defined in Articles 10-15, and the EUDAMED database requirements are covered in Article 30.
Economic operators include:
- EU authorized representatives
- Person with regulatory responsibility
Each of the above economic operators must also comply with new roles and responsibilities that are defined in the IVDR, and those activities must be implemented, documented, and maintained with standard operating procedures (SOPs). The goal of the economic operator designation is to establish greater accountability across the regulatory submission process as well as the supply chain and create a system of checks and balances for medical devices that are brought to market.
Manufacturers must establish quality management and risk management systems in accordance with the IVDR, as well as the proper technical documentation for each medical device. Technical documentation, along with the EU declaration of conformity, must be made available to competent authorities in the Member States and translated into the appropriate language(s). In the event of a product nonconformity, the manufacturer must take the necessary corrective actions to resolve the issue or recall the device.
Manufacturers must register with the European database for medical devices (EUDAMED) and provide the necessary information, including unique device identifiers (UDIs). If a manufacturer’s registered place of business resides outside the EU, it must designate an authorized representative to perform the tasks set forth by the IVDR. A mandate outlining the necessary duties must be agreed upon and signed by the authorized representative.
An authorized representative must perform the tasks outlined in the mandate and agreed upon between it and the manufacturer to ensure compliance. This includes maintaining copies of the technical documentation and EU declaration of conformity for each medical device.
Authorized representatives must also register with EUDAMED and take necessary corrective actions to resolve product nonconformity issues.
Importers must maintain copies of technical documentation and EU conformity assessments for each medical device and provide to competent authorities of the Member States upon request. They must also ensure that the device is labeled in accordance with the regulations and include the necessary instructions for use. The importer’s registered trade name, place of business, and contact information should also appear on the device labeling or packaging.
Importers must register with EUDAMED and ensure that necessary corrective actions are taken to resolve product nonconformity issues. Any complaints or reports of serious incidents should be forwarded to the manufacturer or authorized representative.
Distributors should ensure that the appropriate CE marking, EU declaration of conformity, labeling, and instructions for use (in the appropriate languages) have been prepared for each device. They should also ensure that the manufacturer has assigned the appropriate unique device identifiers (UDIs).
Distributors should meet the manufacturer’s device storage and transport requirements and take the necessary corrective actions to resolve product nonconformity issues. They must also inform the manufacturer, authorized representative, and importer of any complaints, serious incidents, device recalls, or withdrawals.
Person With Regulatory Responsibility
Manufacturers should assign at least one person within the organization to be responsible for regulatory compliance. This person should ensure that the conformity of the device is in accordance with the quality management system under which it is manufactured. This person should also ensure that the technical documentation and EU declaration of conformity are kept up to date, post-market surveillance obligations are compiled in accordance with Article 10, and that any serious incidents or field safety corrective actions are reported.