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- ÀÎÁõ±â°ü ½É»ç º¸¿Ï ´ëÀÀ ¹× ÀÛ¼º Áö¿ø
ACTS´Â EU MDR 2017/745 ±ÔÁ¤¿¡ µû¶ó ÀÇ·á±â±â Á¦Á¶¾÷ü°¡ CE ¸¶Å·À» ȹµæÇÒ ¼ö ÀÖµµ·Ï ÀÎÁõ Áغñ ¹× ¹®¼È ¼ºñ½º¸¦ Á¦°øÇÕ´Ï´Ù. CE ¸¶Å·Àº ÀÇ·á±â±â°¡ À¯·´ ½ÃÀå¿¡¼ ÆÇ¸ÅµÇ±â À§ÇÑ Çʼö Á¶°ÇÀ¸·Î, ÇØ´ç Á¦Ç°ÀÌ ¾ÈÀüÇÏ°í ¼º´ÉÀÌ ÀûÇÕÇÏ¸ç ±ÔÁ¦ ¿ä±¸»çÇ×À» ÃæÁ·ÇÔÀ» Áõ¸íÇÕ´Ï´Ù. ¼³°è, Á¦Á¶, À¯Åë Àü¹Ý¿¡ °ÉÄ£ ÀýÂ÷ ¹× ±â¼ú ¹®¼ ÀÛ¼º ¹× ±ÔÁ¤ Áؼö¸¦ À§ÇÑ ¼ºñ½º¸¦ ü°èÀûÀ¸·Î Á¦°øÇÕ´Ï´Ù.
ACTS´Â ÀÇ·á±â±â Á¦Á¶»ç°¡ FDA ¿ä±¸»çÇ×À» ÃæÁ·Çϰí, ¹Ì±¹ ½ÃÀå¿¡ Á¦Ç°À» ½Å¼ÓÈ÷ Ãâ½ÃÇÒ ¼ö ÀÖµµ·Ï ´ÙÀ½ÀÇ ¼ºñ½º¸¦ Æ÷ÇÔÇÑ Á¾ÇÕÀûÀÎ ¼Ö·ç¼ÇÀ» Á¦°øÇÕ´Ï´Ù.
CE ¸¶Å·Àº Á¦Ç°ÀÌ À¯·´¿¬ÇÕ(EU) ±ÔÁ¦ÀÇ Çʼö ¾ÈÀü ¹× ¼º´É ¿ä±¸»çÇ×À» ÁؼöÇÔÀ» ³ªÅ¸³»´Â Ç¥½ÄÀÔ´Ï´Ù. EU MDR 2017/745´Â ÀÇ·á±â±âÀÇ ¾ÈÀü¼º ¹× ¼º´ÉÀ» °ÈÇϱâ À§ÇØ ¼³°è, ÀÓ»óÆò°¡, À§Çè °ü¸® ¹× »çÈİü¸®(PMS)¿¡ ´ëÇÑ ¾ö°ÝÇÑ ¿ä±¸»çÇ×À» µµÀÔÇÑ ±ÔÁ¤ÀÔ´Ï´Ù. CE ¸¶Å·Àº ÀÇ·á±â±âÀÇ ¼³°è ¹× Á¦Á¶¾÷ü°¡ ±ÔÁ¤ ¿ä±¸»çÇ×À» ÃæÁ·ÇßÀ½À» ÀÔÁõÇϱâ À§ÇØ ÇʼöÀûÀ¸·Î ¿ä±¸µË´Ï´Ù.
µî±ÞºÐ·ù ü°è: Class I, (Class Im, Class Is, CLass Ir), Class IIa, Class IIb, Class III
* Im (Measurement), Is (Sterile), Ir (Reuse) ÀáÀçÀû À§Çèµµ¸¦ ±âÁØÀ¸·Î 4°³ µî±ÞÀ¸·Î Á¤ÇÔ.
ÀÇ·á±â±â µî±Þ ºÐ·ù: Annex VIII¿¡ µû¶ó 22°³ÀÇ Rule¿¡ ±Ù°ÅÇÏ¿© ºÐ·ù
ÀÇ·á±â±â ºÐ·ù ±âÁذú ¿ë¾î
»ç¿ë±â°£ (Duration) | ÀϽÃÀû (Transient, 60ºÐ À̳»), ´Ü±â°£ (Short term, 30ÀÏ À̳»), Àå±â°£ (Long term, 30ÀÏ ÀÌ»ó) |
»ðÀÔ (Invasiveness) | »ðÀÔ¿ë ±â±â (Invasive Device), ü°ø (Body Orifice), ¿Ü°úÀû »ðÀÔ (Surgically Invasive), À̽İ¡´ÉÇÑ ±â±â (Implantable Device) |
Àç»ç¿ë¿©ºÎ | Àç»ç¿ë °¡´ÉÇÑ ¿Ü°ú¿ë ±â±¸ (Reusable Surgical Instrument) |
»ç¿ëºÎÀ§ | Áß¾Ó¼øÈ¯±â°èÅë (Central Circulatory System), Á߾ӽŰæ°èÅë (Central Nervous System) |
´Éµ¿¿©ºÎ | ´Éµ¿±â±â (Active Medical Device), ´Éµ¿Ä¡·á±â±â (Active Therapeutical Device) |
# | ±¹¹® | ¿µ¹® |
---|---|---|
1 | ÀÇ·á±â±â¿¡ ´ëÇÑ ¼³¸í ¹× ±â±âÀÇ »ç¾ç (±â±âÀÇ ÀǵµµÈ ¸ñÀû, Àû¿ë ´ë»ó Áúȯ, »ç¿ë ´ë»ó ȯÀÚ, »ç¿ë½Ã ÁÖÀÇ»çÇ× µî) | Device description and specification (intended purpose, medical conditions, intended patient population, warmins, etc.) |
2 | ÀÌÀü ¼¼´ë ¹× À¯»çÇÑ ¼¼´ëÀÇ ÀÇ·á±â±â¿¡ ´ëÇÑ ÂüÁ¶ | Reference to previous and similar generation of the medical device |
3 | Á¦Á¶ÀÚ°¡ Á¦°øÇÏ´Â Á¤º¸ (¶óº§ ¹× »ç¿ë¼³¸í¼) | Information to be supplied by the manufacturer (Label and instructions for use) |
4 | ÀÇ·á±â±âÀÇ ¼³°è Á¤º¸ ¹× Á¦Á¶ Á¤º¸ | design and manufacturing information |
5 | ÀϹÝÀûÀÎ ¾ÈÀü¼º ¹× ¼º´É ¿ä±¸»çÇ× | General safety and performance requirement |
6 | À̵æ-À§ÇèºÐ¼®À» Æ÷ÇÔÇÑ À§Çè°ü¸® | Benefit-risk analysis and risk management |
7 | ÀÇ·á±â±âÀÇ »çÀü ÀÓ»ó ¾ÈÀü¼º | Pre-clinical safety of the medical device |
8 | »ýü ÀûÇÕ¼º Å×½ºÆ® | Biocompatibility of the medical device |
9 | ¹°¸®Àû, ÈÇÐÀû, ¹Ì»ý¹°ÇÐÀû Å×½ºÆ® | Physical, chemical and microbiological tests |
10 | Àü±â¾ÈÀü¼º ¹× ÀüÀÚ±âÀû ÀûÇÕ¼º Å×½ºÆ® | Electrical safety and electromagnetic compatibility tests |
12 | ÀÇ·á±â±âÀÇ À¯È¿±â°£À» Æ÷ÇÔÇÑ ¾ÈÁ¤¼º ½ÃÇè | Stability test including shelf life |
13 | ÀÓ»óÆò°¡°èȹ¼ ¹× º¸°í¼¿Í ¾÷µ¥ÀÌÆ® | Clinical evaluation plan, report, and its updates |
14 | PMCF °èȹ ¹× Æò°¡º¸°í¼ | PMCF(Post-market clinical follow-up) plan and evaluation report |
15 | ¾ÈÀü¼º ¹× Àӻ󼺴É(SSCP)ÀÇ ¿ä¾à | Summary of Safety and Clinical Performance(SSCP) |
16 | ǰÁú°ü¸® ¹®¼È | Quality management documentation |
17 | »çÈÄ °¨½Ã°èȹ ¹× º¸°í¼ | Post-market surveillance plan and report |
18 | ÀÇ·á±â±â Vigilance | Vigilance of the medical device |
19 | EU ÀûÇÕ¼º ¼±¾ð¼ (DoC) | EU Declaration of Conformity |
°ü·ÃµÈ »ó´ãÀ» ¿øÇÏ½Ã¸é ¾ðÁ¦µçÁö ACTS¿¡ ¹®ÀÇÇØ ÁÖ¼¼¿ä.