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 medical device repackaging firm that operate in Europe need to comply with the MDR and IVDR importer
To ease that requirement, we provided a summary of its requirements and differentiated it from the old directives Medical Devices Directive (MDD).
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What Is Medical Device Repackaging? 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 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 importers and distributors. All the medical devices undergo stringent technical documentation for CE marking.
Summary of the Regulation
The 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
Complying with the Regulation
Under the new regulation, importers and distributors who plan to repackage and relabel medical devices must report the changes made to their respective manufacturers. They should clearly outline their intent no less than 28 days from making the newly packaged or labeled devices available to the market.
If asked, the importers and distributors must also give the manufacturers mockups or samples of the new packaging for approval.
Key Differences between the MDD and the MDR
The new regulations require most companies to update their labeling processes. Unique Device Identification (UDI) is now mandatory to track devices through the supply chain.
All label information must be included in the declaration of conformity and must remain up-to-date and available in the official language of the country in which the medical healthcare device is supplied. For example, a medical device sold in Austria must have a product label and manual in German.
In sum, medical device importers and distributors who plan to repackage or relabel medical devices targeting the EU market must report their intent to the respective manufacturers no less than 28 days from making the devices available. They also have to present new packaging mockups or samples, if asked, for approval. Finally, they must notify medical device manufacturers about their plans in writing.