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MDR (CE¸¶Å·)
MDR (CE¸¶Å·)

À¯·´ ÀÇ·á±â±â MDR ÀÎÁõ (CE ¸¶Å·)

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.

ÁÖ¿ä¼­ºñ½º

  • ±â¼ú ¹®¼­ ¹× ÀÓ»ó Æò°¡ º¸°í¼­ ÀÛ¼º Áö¿ø
  • ÀÎÁõ±â°ü ½É»ç º¸¿Ï ´ëÀÀ ¹× ÀÛ¼º Áö¿ø

CE ¸¶Å·À̶õ?

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.

CE MDR ÀÇ·á±â±â ºÐ·ù ü°è

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

  • Non-Invasive Device (ºñ»ðÀÔ ÀÇ·á±â±â): Rule 1~4
  • Invasive Device (»ðÀÔ ÀÇ·á±â±â): Rule 5~8
  • Active Device (´Éµ¿ ÀÇ·á±â±â): Rule 9~13
  • Special Rule (Ưº° ±ÔÄ¢): Rule 14~22

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)

MDR ÀÎÁõ ÀýÂ÷

* ºÎÀûÇÕ ¹ß»ý ½Ã ºÎÀûÇÕ »çÇ×(¹®¼­ ¶Ç´Â »ùÇÃ) º¸¿ÏÁøÇà ÇÊ¿ä

MDR ÇÊ¿ä ¼­·ù

# ±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
*Á¦ÃâµÇ´Â ±â¼ú¹®¼­ Ç׸ñÀº Á¦Á¶»ç ¹× Á¦Ç°¿¡ µû¶ó »óÀÌÇϹǷΠµî±Þ ¹× Ư¼ºÀ» °í·ÁÇÑ Áغñ°¡ ¿ä±¸µÊ

ÁøÇàÀýÂ÷

STEP 01
¿ÀÇÁ´× ¹ÌÆÃ ÁøÇà ¹æÇâ ³íÀÇ
STEP 02
Technical FIle ÀÛ¼º
STEP 03
Notified Body ¼±Á¤ ¹× ½É»ç½Åû
STEP 04
½É»ç Follow-up
STEP 05
CE ÀÎÁõ ȹµæ

°ü·ÃµÈ »ó´ãÀ» ¿øÇÏ½Ã¸é ¾ðÁ¦µçÁö ACTS¿¡ ¹®ÀÇÇØ ÁÖ¼¼¿ä.

ÄÁ¼³ÆÃ ´ã´ç
¿ÀÇý¿µ ¼ö¼® hy.oh@actslab.co.kr