EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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emdt.co.uk European Medical Device Technology Summer 2015 | 13 UDI labeling, GUDID, and new date format requirements by 24 September 2014. Class III life-supporting / life-sustaining (LS/LS) devices must bear a permanent UDI (direct mark) by 24 Sep- tember 2015 if they are intended for reuse and to be reprocessed before each use. All other Class III devices must bear a permanent UDI by 24 September 2016. Implantable Class II, Class I and unclassified implantable devices will need to comply with requirements for UDI labeling, GUDID, and new date formats by 24 September 2015. On the same date, LS/LS devices that are Class II, Class I and unclassi- fied will need to comply not only with the requirements for UDI labeling, GUDID, and new date formats, but must also bear a permanent UDI if they are intended for reuse and to be repro- cessed before each use. Class II devices, other than LS/LS devices, must comply with UDI labeling, GUDID, new date formats and direct marking requirements, where applicable, by 24 September 2016. These types of devices must bear a permanent UDI by 24 September 2018, if they are intended for reuse and to be reprocessed before each use. Class I or unclassified devices, other than implantable, LS/LS devices or exempt Class I devices, will have to comply with UDI labeling, GUDID and new date format requirements by 24 September 2018, and with direct mark requirements, if they are intended for reuse and to be reprocessed before each use, by 24 September 2020. Impact on Labeling, Quality System and Other Regulations The new UDI regulation most directly and extensively affects the U.S. regulation on device labeling found in 21 CFR Part 801. The additions or modifications made to this part include: 0 Sec. 801.3: a new section on definitions of terms, primarily related to UDI requirements 0 Sec. 801.18: the new date format requirements includ- ing exceptions related to combination products that bear a National Drug Code 0 Sec. 801.20: requirement that a device label must bear a UDI with reference to the location of the regulation specifying exceptions 0 Sec. 801.30: general exceptions from requirements for a label to bear a UDI 0 Sec. 801.35: voluntary labeling of a device with a UDI 0 Sec. 801.40: form of a UDI consisting of readable plain text and a form that uses a form that uses AIDC technology 0 Sec. 801.45: devices that must be directly marked with a UDI 0 Sec. 801.50: labeling requirements for standalone software 0 Sec. 801.55: requests for exemption from or alternative to a UDI 0 Sec. 801.57: discontinuation of legacy FDA identification numbers assigned to devices 0 Sec. 801.119: in vitro diagnostic products KNF Flodos AG Product Center Liquid Pumps Switzerland Tel: +41 41 925 00 25 'OCKNOCTMGVKPI"MPHƃQFQUEJ www.knf.com -0(KPVTQFWEGUVJGDCTRTGUUWTGNKSWKFRWOR • DCTEQPVKPWQWUN[ • JKIJEJGOKECNTGUKUVCPEG 2''- • micro design • ECPTWPFT[ • self-priming • maintenance-free • SWKEMJ[FTCWNKEEQPPGEVKQPU 16 bar SMALLER THAN A MATCHBOX

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