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Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The EU acted to adopt UDI and on April 5, 2017, under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), but adoption has been postponed to 2021; see Medical Device Regulation. The timelines for UDI marking of medical devices, direct marking of medical devices, and marking of IVD allow for a staggered introduction. [8]
Due to certain issues, some additional transition timelines were implemented in 2023, amending Article 120 and allowing for some delays in re-certification up until 2028 for class III and IIB implantable devices, and for 2027 for some others, under certain circumstances; the "sell-off" provision of MDD-licensed devices, previously May 2025, was ...
Medical device reporting (MDR), which is the reporting of adverse events with medical devices, is similar to that with medicinal products, although there are differences. In contrast to reporting of medical products reports of side-effects play only a minor role with most medical devices.
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced ...
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