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The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
701 Labeling requirements; 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 ...
EN 868-1 – Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods (superseded by ISO 11607-1) EN 868-5 – Packaging for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods.
Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package. [52] Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests measure the ability of the package to maintain sterility. Relevant standards include:
The timelines for UDI marking of medical devices, direct marking of medical devices, and marking of IVD allow for a staggered introduction. [ 8 ] The EU UDI scheme includes the so-called Basic UDI-DI , a regulatory identifier of a device and key to the EUDAMED database, that does not appear on the device packaging but has to be listed on the ...
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...