European Commission에서는 2018. 4. 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.
 

https://ec.europa.eu/docsroom/documents/29021