This 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
What Is Repackaging and Relabeling? When Does It Apply?
- They must meet the national language 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
These conditions are reviewed on a case-to-case basis and are only applicable to EU importer and distributors.
