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An overview on the implementation of MDR Article 117, Rule 14 and Rule 21.
Download the whitepaper to learn more about:
Integral Drug-Device Combinations (IDDCs) - MDR Article 117.
Drug-Device Combinations - MDR Rule 14.
Substance-Based Medical Devices - MDR Rule 21.
Borderline cases and classification disputes.
Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process.