MDR 규정에 따른 의료기기 CE인증관련 신규 분류등급에 대한 매뉴얼(version1.19) 발간
European Commission에서는 2018년 4월 23일자로 MDR 규정에 따른 의료기기 CE인증관련 신규 분류등급에 대한 매뉴얼을 업데이트 하여 발간하였습니다. 이는 작년 12월에 발간한 1.18버전을 업데이트 한 것으로 Rugby Helmet, Autopsy Saw, UV Lamp, Water Filter, A product that mimics starch in food 제품은 공식적으로 의료기기로 분류될 수 없다는 것과 다음 두 제품에 대한 분류를 추가 확정하였습니다.
- Bone Void Filter : Class 3 according to Rule 8, 13 and 17
- Cryotherapy Chambers : Class 2B according to Rule 9
이와 더불어 주요 제품 중 분류가 확정되어 안내된 것은 다음과 같습니다
- Non-corrective Contact Lenses with a medical purpose(UV blocking contact lenses, bandage lens) : Manufacturers of such products must, however, clearly indicate the specific intended medical purposes for these non-corrective contact lenses both on the packaging / labelling and in the instructions for use. If not, it’s Not Medical Devices.
- Shoe Covers : Class 1 according to Rule 1
- Air Purifiers / Air Decontamination Units / Mobile Air Decontamination Units : Not Medical Devices
- Bone anchored Hearing Aids : Class 2B according to Rule 8
- Tooth Whitening or Bleaching Products : Not Medical Devices
- Surgical Instrument Decontamination Products : Class 2A or 2B according to Rule 15
- Sterilization Indicators : Not Medical Devices
- Dental Curing Lights : Class 1 according to Rule 12
- Autologous Platelet Preparation System
① Platelet Preparation Tube, containing the anti-coagulant solution(ACD) : Class 3 according to Rule 13
② Blood Bags, including those containing or coated with an anticoagulant : Class 2B according to Rule 18
③ Sleeve Filters : Class 2A or 2B according to Rule 3
- Contact Lenses :
① Daily Disposable (Single Use) Contact Lenses : Class 2A according to Rule 5
② Contact Lenses for Daily Wear with Discontinuation of Use Overnight : Class 2A according to Rule 5
③ Contact Lenses for Overnight Wear with Discontinuation of Use during the day : Class 2A according to Rule 5
④ Contact Lenses for Continuous Wear for up to 30 days : Class 2A according to Rule 5
⑤ Contact Lenses for Continuous Wear for more than 30 days : Class 2B according to Rule 5
- Dental Abutments :
① Abutments to be placed in the teeth such as Bridges and Crowns, Dental Filling Materials and Pins and Dental Alloys Ceramics and Polymers : Class 2A according to Rule 8
② Abutments to be placed in the gum : Class 2B according to Rule 8
- A Mobile Application for Processing ECGs : Class 2A according to Rule 10
- A Mobile Medical Application for viewing the anatomy of the human body : Not Medical Devices
추가 세부적인 사항에 대해서는 아래 링크 참고하셔서 MDR전환에 대비하시길 바랍니다.