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HIBCC Is Pleased to Submit to the European Commission Our Enclosed Application to Be Designated As a UDI Issuing Entity

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HIBCC Is Pleased to Submit to the European Commission Our Enclosed Application to Be Designated As a UDI Issuing Entity LETTER OF TRANSMITTAL January 24, 2019 To The European Commission, HIBCC is pleased to submit to the European Commission our enclosed application to be designated as a UDI Issuing Entity. The application includes supporting attachments and material that is numbered to correspond with the information requested in your Call for Applications. We look forward to working with the Commission as it launches this important initiative. Please contact me if additional information or clarification is needed. Sincerely, President & CEO HIBCC European Commission Issuing Entity Application 1. Name, address, and phone number of the applicant; Name: Health Industry Business Communications Council Global Office Address: 2525 E. Arizona Biltmore Circle, Suite 127, Phoenix, AZ 85016 Phone Number: +1 (602) 381‐1091 2. Detailed information regarding the applicant's organisation, including the description of any financial or other relationship between the applicant and any manufacturer or governmental institutions or organisation; HIBCC was established in 1984 by a consortium of healthcare supply chain trade associations for the purpose of creating a bar code (auto‐ID) labeling standard for medical devices. The HIBC Supplier Labeling Standard (SLS) (Attachment 1) was successfully implemented and was followed by a series of related standards for auto –ID labeling, electronic data interchange, provider identification, and other supply chain processes. Over time these have evolved with changing technologies and user requirements. The HIBCC office was created to serve as the global secretariat and accredited standards development organization (SDO) for the SLS and our other standards. We were thereafter accredited by the American National Standards Institute (ANSI) (Attachment 4), recognized as part of the International Organization for Standardization (ISO) network (Attachment 2), the Committee for European Normalization (CEN), etc. We are also a designated Issuing Agency for the US Food and Drug Administration (FDA) UDI regulation. HIBCC is registered and structured as a 501(c)6 non‐profit corporation under US law by the US Internal Revenue Service (Federal EIN 36‐3313052). In addition to registering companies and organizations with company identifiers (known as Labeler Identification Codes) for UDI and product labeling, HIBCC also provides fee‐based database services to companies and government agencies that utilize our Health Industry Number (HIN) System of healthcare provider identifiers. In some cases, HIN users and licensees may also be HIBC SLS product labelers; however HIN services do not relate to the UDI system or our LIC application process. HIBCC standards are maintained in conformance with standard operation procedures, and are designed to assure conformity, patient safety, and supply chain efficiency. Various companies, healthcare institutions, and other organizations, including government agencies, participate in our technical committees. All participants are required to comply with HIBCC’s Antitrust Policy (Attachment 7) and HIBCC’s Conflict of Interest Policy (Attachment 8). HIBCC supports a network of affiliated organizations, such as the European Health Industry Business Council (EHIBCC) and others, to provide technical support to our labelers. However, changes and/or maintenance to the standard, as well as policy, oversight and registration maintenance are the responsibility of HIBCC. Copyright © 2019 Health Industry Business Communications Council, All rights reserved. Health Industry Business Communications Council (HIBCC) . (602) 381-1091 . [email protected] HIBCC European Commission Issuing Entity Application 3. Detailed description of its system for the assignment of UDIs, including description of any standard or criteria applied; The HIBC Supplier Labeling Standard (SLS) (Attachment 1) is accredited by ANSI, and in conformance with the EU MDR and FDA UDI rule. Labelers using the HIBC SLS are required to strictly adhere to the standard in order to be in conformance with all UDI regulations from which they will derive their device and production identifiers. In order to become a labeler, the interested party will register with HIBCC to obtain a Labeler Identification Code (LIC). HIBCC will then assign a unique 4‐digit, alphanumeric code (such as B123) to identify the registrant. The LIC code is never duplicated or reassigned and thus is distinctly unique to that registrant/labeler. HIBCC maintains the LIC assignments in an internal database. The HIBC Supplier Labeling Standard (SLS) is the guideline from which a labeler will derive their UDI data. The HIBC SLS specifies the type of information that should be encoded and the method of doing so. For instance, the primary data string requires a “+” flag character, the 4‐character LIC, a 1‐18 character product or catalog identifier, a one‐digit unit of measure and a single‐digit check characters. Elements of this data string become the device identifier. Secondary information such as lot/batch number, serial number, expiry date an/or date of manufacture are prescribed as well, and will provide the method for developing the production identifier. (Please reference the attached HIBC SLS for specific encoding requirements.) Because the LIC assignment is unique to the individual labeler and never reassigned to a different labeler, when attached to their own product code it inherently creates a unique data string. No two UDIs could be alike because of the uniqueness of the LIC assignment. And because the HIBC SLS is variable length, and alphanumeric there are virtually limitless numbers of possible UDIs. Attached are the American National Standard Institute (ANSI) approved HIBCC Standard Operating Procedures, which document the required process for updating a standard (Attachment 9). All updates to the HIBC Supplier Labeling Standard are made in an effort to support the EU MDR requirements and provide additional clarification surrounding any common areas of confusion. All versions of the standard are backward compatible to ensure that any UDI created in a previous version maintains compliance. All new versions of the HIBC Supplier Labeling Standard (SLS) are approved by ANSI and subsequently published in their publication "Standards Action". HIBCC posts all new versions of the standard on our website and sends an email notification describing any updates to all HIBCC labelers. Additionally, HIBCC works with labelers one‐on‐one to review all changes as requested. Copyright © 2019 Health Industry Business Communications Council, All rights reserved. Health Industry Business Communications Council (HIBCC) . (602) 381-1091 . [email protected] HIBCC European Commission Issuing Entity Application 4. Copies of the application forms, guidelines, instructions, and other materials the applicant will send to manufacturers who plan to use the applicant's system for the assignment of UDIs. Where those materials are still under preparation, the applicant shall provide a detailed plan for adoption of those materials; All labelers receive a welcome letter (Attachment 15) upon registering with HIBCC, which confirms the 4‐character LIC assignment. Labelers are also given the latest copy of the Supplier Labeling Standard (Attachment 1) and the relevant technical guidance documents (Attachment 11, 12, 5, and 6). All guidance documents are created and/or updated constantly. HIBCC plans to release EU MDR specific guidance documents once the MDR guidelines are finalized. 5. Detailed description of the applicant's policies and procedures for determining whether manufacturers may use the applicant's system; The HIBC Supplier Labeling Standard is an open standard and available to all parties that elect to use it. The HIBCC organization is the sole assigner of the Labeler Identification Code (LIC). An application form (Attachment 14) and payment of a one‐time fee (Attachment 10) is required for assignment of an LIC. HIBCC released a Clarification on LIC Fees (Attachment 18) in 2016 to ensure the process maintained clear and transparent for all parties. 6. Description of the applicant’s policies/procedures for dealing with manufacturers’ deficiencies in using correctly the system for the assignment of UDIs, including for monitoring corrections; HIBCC will notify labelers of deficiencies in the use of the HIBC Supplier Labeling Standard by letter (Attachment 3). This notice requires the organization to take corrective action within 30 days of receiving the letter. The most common action would be to update an existing LIC or apply for a new LIC. In the case of an organization using an LIC that is not registered to them, HIBCC would issue a cease and desist letter. Additionally, HIBCC will notify all regulatory bodies including the European Commission and the U.S. FDA, in the event that an organization is using an unregistered HIBCC prefix. 7. Description of business model and fee system, with an explanation and rationale of any fee waiver or reduction available; HIBCC has been registering labelers for 30 years, and will further enhance processes to meet EU MDR requirements. The registration process requires a new labeler to pay a one‐time application to HIBCC for assignment of the Labeler Identification Code (LIC). Thereafter, there are no reoccurring fees to the labeler to maintain their LIC. HIBCC continues to provide technical support and guidance to labelers at their request. The assigned LIC is applied globally, and can be used for the labeling of a registrant’s entire product line. Copyright © 2019 Health
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