FDA UDI vs EU UDI

FDA UDI vs EU UDI

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  FDA UDI vsEU UDI W H I T E P A P E R
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  What is UDI UniqueDevice Identification (UDI) is intended to assign a unique identifier to medical devices within the United States it marks and identifies individual medical devices throughout their distribution and product life. The UDI system was initially created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. With certain exceptions, a UDI will be required to appear on the label of a medical device and be composed of two parts: 1. Device Identifier (DI) - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device; and 2. Production Identifier(s) (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device. This will be dependent upon the manufacturer’s internal quality system. • the lot or batch number within which a device was manufactured; • the serial number of a specific device • the expiration date of a specific device • the date a specific device was manufactured Therefore, UDI = DI + PI. UDI History In 2007, the U.S. FDA developed a labeling system that would uniquely identify every single medical device (MD) on the market. The Global Harmonization Task Force (GHTF) soon recognized the global relevance of such a system and adopted a respective guidance that was last released in 2013 by the International Medical Device Regulators Forum (IMDRF), an international cooperation of regulators made up of industry stakeholders and GHTF successors. (Interestingly, Medical device manufacturers experienced in the U.S. market have quickly recognized the similarity of the EU regulation as compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines. Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745. The EU UDI System, like the U.S. UDI requirements, will be implemented in phases, starting with the highest risk classes first, and lowest risk classes last. FDA UDI vs EU UDI www.DDIsmart.com | 2 What’s UDI? Found on the device label, packaging or, in some cases, on the device itself Both in plain text and machine readable format (AIDC) Manufacturer Qty: 1 each Size: 20mm x 12.5mm Z1234 A12342010-01-022014-01-02 1234 REF Manufacturer full address Phone No.: xxx-555-3226 Website. www.manufacturername.com Manufacturer Name SNLOT UPPER LIMIT OF TEMPERATURE KEEP DRY 45˚C 2 ( 0 1 ) 1 2 3 4 5 6 7 8 9 0 1 2 3 4 ( 1 7 ) 1 4 0 1 0 2 ( 1 1 ) 1 0 0 1 0 2 ( 1 0 ) A 1 2 3 4 ( 2 1 ) 1 2 3 4 UDI = DI + PI
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  EUDAMED EUDAMED will bean information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC. Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored to a database in a standardized format. The EUDAMED project aims to address the effective implementation of this provision of the Directives. FDA UDI vs EU UDI www.DDIsmart.com | 3 ES on Registration ES on Certificates ES on UDI EUDAMED (Possible integration of UDI ES in the future regulatory framework) PI ES on Vigilance ES on CIV ES on Market Survey UDI DI = Device Identifier + PI = Production Identifier Mfgr. / Exp. Date Lot / Batch No. Sl No. DI UDI PMS Vigilance Clinical Investigation Certificates (Issued by Notified Bodies) Registration of Devices & Manufacturers /Operators
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  Key Differences betweenUS GUDID and EU EUDAMED elements EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC. Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored to a database in a standardized format. The EUDAMED project aims to address the effective implementation of this provision of the Directives. Following are common elements between GUDID and EUDAMED but they likely need to be translated into 24 official languages of the EU: 1. Name or Trade name 2. Additional product description 3. Clinical size 4. Storage and handling conditions 5. Additional trade names of the device 6. Critical warning or contra indications EU UDI Compliance Dates* Unlike GUDID, EUDAMED is adopting risk based approach for UDI submissions. Class III and the implantable device must be compliant by 2021, Class IIa and IIb devices by 2023, whereas Class I by 2025. For IVDs, the implementation will also be risk based but delayed the implementation of the IVDR timeline will be different. Class D devices should be compliant by 2023, Class C & B devices by 2025, while Class A devices by 2027. *These compliance deadlines are subject to change as a fulfillment of the requirements is dependent on the progress of the EUDAMED implementation and its availability. www.DDIsmart.com Copyright © 2018 DDI LLC. All rights reserved. Labeler DUNS Number Secondary DI Number Device Subject to Direct Marking (DM), but exempt DM DI different from primary DI (and DM number) Customer contact Prescription use (Rx) and/or Over the Counter (OTC) Device is also a HCT/P, kit and/or Combination product Premarket submission number (PMA, Supplement Number , 510k, or device exempt) FDA product code FDA listing number GMDN code EU EUDAMED The Basic UDI-DI Single Registration Number If applicable, name and address of the authorized representative If applicable, additional trade name of the device Medical device nomenclature code as provided for in Article 26 If applicable maximum number of reuses Where applicable, information labelled in line with Section 10.4.5 of Annex I Risk class of the device URL for additional information If applicable, critical warnings or contra-indication Status- recalled, field safety corrective action initiated 1 2 3 4 5 6 7 8 9 10 11 US GUDID