Are Your Labels EU MDR Compliant? - Medical Device

Are Your Labels EU MDR Ready?Labeling Impacts of the New European Medical Device RegulationCopyright 2018 Quality Tech Services, LLC

PresenterBrian NissenPrincipal Project Engineer B.S. MechanicalEngineering 15 years in MedicalDevice IndustryCopyright 2018 Quality Tech Services, LLC

AgendaHistory & BackgroundLabel Content ChangesUDI & EUDAMEDIFUs & Patient Implant CardsKey DatesHow Can QTS Help?Copyright 2018 Quality Tech Services, LLC

PROMINENTDISCLAIMERWhat follows is based on thepresenter's personal and QTS'collective knowledge regardingEU MDR,UDI and EUDAMEDrequirements. QTS is not asupplier of regulatory services oradvice.The intent of this presentation is toshare our interpretation and bestpractices with our Customerpartners. You are stronglyencouraged to research andimplement these regulations andguidance in a manner supportedby your Quality System(s) andRegulatory resources.Copyright 2018 Quality Tech Services, LLC

History &BackgroundCopyright 2018 Quality Tech Services, LLC

BackgroundWhere We Were: Medical Device Directive (MDD) The Council of the European Communities, Council Directive93/42/EEC Official: June 14, 1993 Several amendments, most recent in 2007Where We Are Going: Medical Device Regulation (MDR) Regulation (EU) 2017 745 of the European Parliament and of theCouncil of the European Union Official: April 5, 2017 Supersedes the MDDCopyright 2018 Quality Tech Services, LLC

Renewed Focus on Users Technical Knowledge, Experience, Education, Training Readily Understood by the Intended UserMDDMDR13.1 Each device must beaccompanied by theinformation needed to use itsafely and properly, takingaccount of the training andknowledge of the potentialusers 23.1(a) The medium, format, content, legibility, andlocation of the label and instructions for use shall beappropriate to the particular device, its intendedpurpose and the technical knowledge, experience,education or training of the intended user(s). Inparticular, instructions for use shall be written interms readily understood by the intended user and,where appropriate, supplemented with drawings anddiagrams Copyright 2018 Quality Tech Services, LLC

Renewed Focus on Safety and Transparency Device safety and clinical effectivenessdata is required to be transparentlyshared with users via EUDAMED andInstructions for Use (IFUs) Safety and Effectiveness is Paramount– Device certification through equivalencyhas become more rigorous– Data is required for all submissionsCopyright 2018 Quality Tech Services, LLC

Label ContentChangesCopyright 2018 Quality Tech Services, LLC

Label Content Changes Name or Trade Name ofthe Device Manufacture Date(if no Expiration Date)Copyright 2018 Quality Tech Services, LLC

Label Content Changes Indication that the deviceis a Medical Device Warnings or Precautionsthat need to be brought tothe immediate attentionof the userNot an internationallyrecognized symbol eIFU– Add Web AddressCopyright 2018 Quality Tech Services, LLC

Label Content Changes Explicit Requirements forSterile Barrier Labeling– Identification the sterile barrier– Declaration of the SterileCondition (e.g. Sterile, NonSterile)– Sterilization Method– Manufacture Date(Month & Year)Not an internationallyrecognized symbol– Expiration Date(Month & Year)– Directive to check IFU ifpackage appears damagedCopyright 2018 Quality Tech Services, LLC

Label Content Changes Absorbed Materials– Overall composition forabsorbed devices andquantitative information onthe main constituent(s)Not an internationallyrecognized symbolCopyright 2018 Quality Tech Services, LLC

Label Content ChangesItems Not Applicableto our Label Number of times a singleuse device has beenreprocessed Serial Number is requiredfor all active implantablesCopyright 2018 Quality Tech Services, LLC

Label Content ChangesItems Not Applicableto our Label Specific warning for devicesincluding substances that are:– Carcinogenic– Mutagenic– Toxic to reproduction– Endocrine-disrupting properties Indication that the devicecontains tissue or cells ofanimal or human originCopyright 2018 Quality Tech Services, LLC

Label ComparisonCopyright 2018 Quality Tech Services, LLC

Unique DeviceIdentificationCopyright 2018 Quality Tech Services, LLC

UDI Unique Device Identification Very similar to the US FDA rule Unique identifying “part numbers” issued by a neutralparty; assigned to your finished products Product packaging must be labeled with the UDI Some products must bear the UDI on the product itself(Direct Part Marking) UDIs must be registered in a database (EUDAMED)Copyright 2018 Quality Tech Services, LLC

Why UDI? Required to place a unique identifier– Non-partial agency– On packages and sometimes products Required to place certain production information– Machine-readable form Why do we do this?– Serves as the “primary key” of the regulatory database– Part numbering scheme may be the same as anotherCopyright 2018 Quality Tech Services, LLC

Designated Issuing AgenciesCopyright 2018 Quality Tech Services, LLC

Composition of a UDI SymbolDevice Identifiers Production Identifiers 0)0000DDDYYzxxCopyright 2018 Quality Tech Services, LLCProductionIdentifiers

Composition of a UDI SymbolDevice Identifier: Version or model of the deviceLabeler of the devicePackage quantity (unit of sale, multi-pack, etc.)Issued by your agencyCopyright 2018 Quality Tech Services, LLC

Composition of a UDI SymbolProduction Identifier: Conditional, Variable Identifies the following IF included on the Device Label– Lot/Batch Number– Serial Number– Software Identification– Expiration Date– Manufacturing Date(if no expiration date)Copyright 2018 Quality Tech Services, LLC

Location of UDI Symbol Label of the Device and all Higher Levels of Packaging– Primary package of the device– Multi-pack sales units Does NOT include shipping containers Reusable Devices– Device itself must be marked– Remain throughout the intended lifetime of device Some exclusionsCopyright 2018 Quality Tech Services, LLC

EUDAMEDCopyright 2018 Quality Tech Services, LLC

What is EUDAMED? European Databank on Medical Devices Currently exists, and use has been mandatory foruse since 2011 MAJOR overhaul for MDR Planned Launch Date of March 25, 2020Copyright 2018 Quality Tech Services, LLC

MDR / EUDAMED / UDI StructureEUDAMEDEuropean MD/IVD DatabaseCERTIFICATES- Issued- Suspended- Withdrawn- Refused- RestrictedVIGILANCE- SeriousIncidentsCLINICALINVESTIGATION- Sponsor- FSCA- Purpose- FSN- Status- CorrectiveActions- Approval- SummaryMARKETSURVEILLANCE- Measurestaken by MS- Preventativehealthmeasures- Non-compliantdevicesUDI Registration for DevicesRegistration of Manufacturers and Economic OperatorsCopyright 2018 Quality Tech Services, LLC

InstructionsFor UseCopyright 2018 Quality Tech Services, LLC

IFU Changes Many Changes:– MDD has 17 sub-sections, MDR has 28 sub-sections– MDR sub-sections are much more descriptive Highlights:– Specification of the expected clinical benefits– Links to data on clinical performance and safety (EUDAMED)– Special training and/or facilities required to use the device– Information on the correct installation, operation andmaintenance of the device– What to do if the sterile barrier appears damaged– Information on the reuse of single-use devices– Expanded requirements for warnings to the usersCopyright 2018 Quality Tech Services, LLC

Patient Implant Cards New Requirement; OnlyApplies to Implants Required Info– Device Name– Serial Number and/or Lot Number– UDI– Device Model– Manufacturer Name, Address &Website Health Institutions Required to Provide Rapid Accessto Additional InformationCopyright 2018 Quality Tech Services, LLC

Next StepsCopyright 2018 Quality Tech Services, LLC

Key DatesWHENWHATNOTESNovember 2017Notified Body designationprocess beginsEU pares down the list of approvedorganizations for accepting andcertifying productsMay 26, 2020All device certifications andrecertifications must beperformed under MDRMay 26, 2022All certifications andrecertifications must beperformed under IVDRMay 26, 2024All MDD and IVDD certificatesbecome void.Any medical devices or IVDs to besold must have MDR/IVDRcertificates.May 26, 2025All medical devices and IVDsput into service, must haveMDR/IVDR certificates.Nothing certified under the oldsystem can be used for the firsttime.Copyright 2018 Quality Tech Services, LLC

How can QTS help you succeed?Expertise GS1 and HIBCC barcodes Label symbology updatesIndustry Partners IFUs and printed contentCretex Medical Partners Direct Part MarkingCopyright 2018 Quality Tech Services, LLC

Q&A SessionConnect with QTS: Contact your QTS Account Manager Email: info@qtspackage.com Online: qtspackage.com Phone: 952.942.8321 Social Media:Copyright 2018 Quality Tech Services, LLC

Resources & References Regulation (EU) 2017 745 of the European Parliament and of the Council of the EuropeanUnion ri CELEX:32017R0745) GS1 Website (www.GS1.org) GS1 Guide on Unique Device Identification (UDI) implementation in the USA and in theEU thcare/positionpapers/gs1 udi guide final 20170324.pdf) Health Industry Business Community Council (HIBCC) Website (www.HIBCC.org) International Council for the Commonality in Blood Banking Automation (ICCBBA)Website (www.iccbba.org) ISO/IEC 15415:2011 – Information Technology – Automatic identification and data capturetechniques - Bar code symbol print quality test specification – Two-dimensional symbols ISO/IEC 15416:2000 – Information Technology – Automatic identification and data capturetechniques - Bar code print quality test specification – Linear symbols QTS Resources Page Copyright 2018 Quality Tech Services, LLC

Thank You.Quality Tech Services, LLCwww.qtspackage.com952-942-8321Copyright 2018 Quality Tech Services, LLC

All medical devices and IVDs put into service, must have MDR/IVDR certificates. Nothing certified under the old system can be used for the first . ISO/IEC 15416:2000 – Information Technology –Automatic identification and data capture techniques - Bar c