Article 16(4) of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) requires distributors and importers to obtain a certificate from a Notified Body to demonstrate that their quality management system (QMS) complies with the requirements of Article 16(3). This certificate is required for activities such as:
    • Repackaging
    • Relabeling
    • Translating information provided by the manufacturer
    • Adding information to market the device in a specific Member State

The Medical Device Coordination Group (MDCG) provided the following documents to help clarify these requirements: MDCG 2021-23  and MDCG 2021-26.

To further understand these requirements, to whom they apply and how to ensure your company is compliant, reach out to us at DPinfo@dpdconline.com or 804-965-3981. We look forward to hearing from you and helping you navigate the MDR/IVDR regulations. For more about our consultation services, click here.
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