Both MDR and IVDR have introduced a more stringent operational framework for Economic Operators within the Medtech and Biotech industries
The European Commission has been gradually involving economic operators in more CE-marking-related activities and MDR/IVDR, have set the scene with new roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors, which remain distinct for some activities but also overlap in many others.
📌 Manufacturers: responsible for Eudamed registration, technical documentation, design, development manufacture and assembly, handling, storage and distribution, corrective actions, #UDI labeling, complaints, postmarket surveillance and the PRRC.
📌Authorized Representatives: responsible for EUDAMED registration, technical documentation, corrective actions, UDI labeling, postmarket surveillance and PRRC.
📌Importers: responsible for EUDAMED registration, handling, storage and distribution, corrective actions, UDI labeling, postmarket surveillance.
📌Distributors: responsible for handling, storage and distribution, corrective actions, UDI labeling, complaints and postmarket surveillance.
Did you know?
👉 Both the Manufacturer and the Authorized Representative must assign a Person Responsible for Regulatory Compliance within their organization or at their disposal
👉 Each Authorized Representative has to have at least one PRRC, that should be located in the EU.
👉 An Authorised Representative must also keep copies available of all documents and make them accessible to authorities on request including technical documentation, declaration of conformity, and certificates, including their amendments and supplements
👉 Some Manufacturer activities cannot be delegated to an Authorised Representative, e.g. requirements related to the design of a device, the Quality Management System, or the drafting of technical documentation
👉 Legacy devices are subject to MDR IVDR registration requirements with some exceptions such as the assignment of a basic UDI-DI.
👉 Legacy devices without a Basic UDI-DI or UDI-DI will still be required to have a EUDAMED DI, which is equivalent to a Basic UDI-DI, and a EUDAMED ID.
✔ You can have more than one PRRC with different roles and responsibilities that must be defined in written
✔Name and contact details of the PRRC will be disclosed in the EUDAMED database
✔ The PRRC does NOT replace the Authorized Representative. You need both if you located outside of the EU!
✔ The role is also mandatory in the IVDR context
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