For medical device companies working with relabeling and repackaging, the new MDR and IVDR requirements can seem complex. This simple guide will help you ensure complete compliance.
EU MDR / IVDR Requirements for Medical Device Repackaging and RelabelingThis post discusses the basics of the European Union (EU) Medical Device Regulation (MDR) and In Vitro Device (IVD), which took effect on 26 May 2021. All medical device manufacturers, importers, and repackagers that operate in Europe need to comply with the MDR and IVDR To ease that requirement, we provided a summary of its requirements and differentiated it from the old directives Medical Devices Directive (MDD).
What Is Repackaging and Relabeling? When Does It Apply?According to the Medical Device Coordination Group (MDCG) 2021–26 Q&A document, repacking and relabeling medical devices need to meet “necessary in order to market” conditions before they can be marketed in any EU Member State. Here are some of the specific conditions medical device repackagers and relabelers must adhere to satisfy MDCG requirements.
- They must meet the national requirements of their target markets when providing medical device information.
- They must be able to satisfy specific customer requirements. If the manufacturer’s packaging does not meet their needs in terms of number of devices per package, for instance, the repackager or relabeler must be able to make the necessary adjustments. This requirement also applies to:
- Health insurance guidelines that stipulate a specific size for medical device packaging so the customer’s insurance will cover it during reimbursement
- Long-standing medical prescription establishment rules
Summary of the RegulationThe current MDCG guideline document clarifies the standards outlined in the new regulations. It is particularly concerned with the actions that medical device importers and distributors can carry out, which will not be considered equipment modifications. In other words, importers and distributors are not subject to the same obligations that medical device makers are. The document specifically does these:
- Provide Instructions for Use (IFU) translations and supplies, which comprise relabeling
- Make changes to a device’s external packaging for commercialization purposes in target Member States, also known as “repackaging”
- Plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class of the device