M EDICAL D EVICE R EGULATION (MDR) EUROPE Volker Zeinar 07 Nov 2019 - GS1 Healthcare Conference, New Delhi
AGENDA I. MDR overview II. UDI requirements III. EUDAMED IV. Conclusion
EU Regulation MDR 2017 / 745 KEY DATES MDR Publication 05 May 2017 Entry into force 26 May 2017 Date of Appl. 26 May 2020 Transition Period 26 May 2024 Chapte Subject r I Scope / Definitions 10 chapters - 123 articles - 17 annexes II Making available +putting into service, obligations economic operators, reprocessing, CE marking, … 175 pages - replaces the MDD 93/42/EC III Identification, traceability, registration of economic operators + devices, EUDAMED, … IV Notified Bodies V Classification / conformity assessment Anx Subject S C O P E VI Clinical evaluation / investigation I General safety + performance requirements all Medical Devices VII Post-market surveillance, vigilance, market surveillance II Technical documentation … … VIII Cooperation between MS, Med Dev Coord. Group, expert panels, … Except : VI Registration + UDI IX Confidentiality, data protection, funding, penalties Custom-made dev … … X Final provisions Perform.study/investig. dev XVII … B. Braun Melsungen AG 3
MDR Building Blocks Technical Classification Scrutiny Documentation UDI Person Vigilance responsible for Regulatory Compliance Clinical Evidence Market Surveillance Notified Bodies Notified Bodies EUDAMED Eudamed B. Braun Melsungen AG 4
MDR Building Block 1 Technical Classification Scrutiny Documentation UDI Person Vigilance responsible for What does it mean? • Recertification of all approved devices Regulatory Compliance Clinical • Reclassification / new classification rules Evidence • Stricter pre-market control (high risk dev) Market Surveillance Notified Bodies Notified Bodies EUDAMED Eudamed • Structure of RMF changes / more content B. Braun Melsungen AG 5
MDR Building Block 2 • New rules/more clinical investigat. • More rigorous clinical evidence Technical Classification Scrutiny Documentation • Publ. of safety + performance data UDI • NB’s increased authority (PMS) Person Vigilance responsible for • Unannounced audits (MD sample checks) Regulatory Compliance • Strengthening PMS requirem. MFR Clinical Evidence • Periodic Safety Reports (4 types) Market Surveillance Notified Bodies Notified Bodies EUDAMED B. Braun Melsungen AG 6
MDR Building Block 3 Person responsible for : Technical • product conformity checked before Classification Scrutiny Documentation batch release UDI • Tech. doc up-to date Person Vigilance responsible for • Vigilance reports, FSCA, … Regulatory Compliance Clinical NB : Evidence • re-accreditation Market Surveillance Notified Bodies Notified Bodies EUDAMED Eudamed • Strengthened designation criteria • Number will be reduced B. Braun Melsungen AG 7
MDR Building Block 4 Technical Classification Scrutiny Documentation UDI Person Vigilance responsible for Regulatory Compliance Clinical Evidence Market Surveillance Notified Bodies Notified Bodies EUDAMED Eudamed B. Braun Melsungen AG 8
UDI Requirements in a Nutshell In accordance with the new rules, any manufacturer before placing a device on market shall assign to the device and to all higher levels of packaging a UDI. The UDI carrier shall be placed on the label of the device, on all higher levels of packaging and in some cases on the device itself. Before a device is placed on the market the manufacturer shall ensure that the information – related to the device in question - referred to in Part B of Annex VI of the two Regulations (MDR / IVDR) is correctly submitted and transferred to the UDI database. The manufacturer is the entity responsible for complying with all UDI related requirements. 4 Issuing Entities GS1 – HIBCC – ICCBBA – IFA B. Braun Melsungen AG 9
UDI Labeling + Direct marking UDI placed on Device Labels UDI placed on the Device itself AIDC + HRI Reusable devices subject of DM • all package levels (excl. shipper) AIDC + HRI • UDI containing DI + PI • UDI containing DI + PI Space constraints Permanent readable throughout the intended lifetime • on Base Pack UDI on next Higher Package Level Exceptions: • to print both AIDC + HRI AIDC has the higher priority Single-use devices of EU risk-class I or IIa • DM interferes with the safety/performance • no UDI on Base Pack require • Technologically not feasible Special rules for certain device categories • Space constraints (AIDC has the higher priority) • Software, Kits, Proc. Packs, Complex Systems, OTC, … AIDC technology neutral AIDC technology neutral AIDC Quality according to the IE rules (ISO quality grade) AIDC Quality acc. IE rules (ISO quality grade) B. Braun Melsungen AG 10
DI PI • i.e. GTIN • Lot/Batch • Exp. Date • Serial No • Manuf. Date B. Braun Melsungen AG 11
EUDAMED – Core of the legislation REG Manufacturer, Authorized Rep, Syst/Proc-Pack Producer, Importer, Notified Body ACT Complex DB-System Device - Registration with different modules Data for an entire CERT & functionalities FAMILY of devices DEV EUDAMED 6 Modules : UDI • REG – Registration UDI CI ACT – Actor (SRN) Data for SINGLE devices VIG DEV – Device (Basic UDI) & package levels PMS • UDI (highest data granularity) • CERT – Certificates • VIG – Vigilance • PMS – Market Surveillance • CI – Clinical Investigation B. Braun Melsungen AG 12
Device Family : Characteristics + Identification Consists of one or many family members (single devices) All family members: • share the same documentation Certificate (incl. CERT for free-sale) Declaration of conformity (DoC) Technical documentation (Regulatory Master File) Summary of safety and clinical performance • have the same intended purpose EU device risk-class essential design and manufacturing characteristics Family to be identified by a ‘ BASIC UDI-DI’ Independent from Does not appear on Referenced in tech. Main access key to packaging labeling documents EUDAMED B. Braun Melsungen AG 13
Device Identifier Types Basic UDI-DI (GS1 Standard = Global Model Number) UDI-DI • Lowest package level (Base Pack) of the devices with a device label • Can also be the device itself (e.g. in case of reusable devices / direct marking) DM-DI • DI of the unpackaged reusable device (in case the device is direct marked) Package-DI • Higher package configurations (e.g. Box of 10 Pieces, Carton of 100 Pieces) How does that • Shipper case is out of scope fit together? Unit-of-Use DI • In case the lowest package level (Base Pack) contains more than 1 piece B. Braun Melsungen AG 14
Hierarchy of a Device Family (example) „Device Family“ Basic Modell Declaration of Conformity (DoC) Techn. documentation •1 - 1 UDI-DI ‚AT100‘ Certificates •1 - n • Basic UDI-DI REF REF REF REF • UDI-DI „Family Members“ ‚AT100A‘ ‚AT100B‘ ‚AT100C‘ ‚AT100X‘ • DM-DI •1 - 1 Label Label Label Label • Unit-of-Use DI •1 - n • CE marked • CE marked • CE marked • CE marked • Package-DI • English • English • French/German • Polish CRS CRS CRS CRS • Gauge 14 • Gauge 18 • Gauge 14 • Gauge 10 • … • … • … • … „Package Levels“ Qty DI Qty DI Qty DI Qty DI Level UoU-DI 1 D UoU DM-DI Base Pack 1 A 15 E 1 G 1 I UDI-DI level of GTIN allocation according GS1 Standards 2nd 50 B 45 F 10 H (always linked to a pack.level) Package-DI‘s 3rd 250 C - - GS1 : DI = GTIN RULE : an UDI-DI can only be linked to ONE Basic UDI-DI B. Braun Melsungen AG 15
EUDAMED Data Elements Modules : DEV & UDI MODULE D Device E Family V Member Member Member 1 2 3 U PL1 PL1 PL1 D I 3 different data sets PL2 PL2 • Data for a device family Basic UDI-DI • Data for a single devices UDI-DI (+ UoU-DI + DM-DI) • Data for a package level of a single device Package-DI PL3 • Limited data set for Systems or Procedure Packs B. Braun Melsungen AG 16
EUDAMED – Data input options Web based forms • Manual input - time consuming • Only for a low number of devices suitable Bulk upload via web form • XML data – validation against 100’s of rules • Semi-automatic communication in one direction (failed uploads logged) Machine-to-Machine (M2M) • Mass data (high number of devices) • XML data – validation against 100’s of rules • Full-automatic communication in both directions • Requires an access point for secure data transmissions (eDelivery) B. Braun Melsungen AG 17
EUDAMED Development Roadmap MDR DoA (26. May 2020) EUDAMED Go-Live (26. May 2022) FUNC Step-1 Step-2 Step-3 Step-4 2 years delay ! Mar 2020 Nov 2020 May 2021 May 2022 ACT minor DEV Decision: 31. Oct 2019 UDI minor How to bridge the gap? CERT • apply corresponding MDD provisions VIG PMS Consequences? (MFR, NB, CA) CI • BUDI/UDI-DI assignment? • Tech. Doc? PUB • Incident reporting? DTX • Transition period (May 2024)? • … Enhancements Basics EUDAMED to be analyzed + bug fixes fully functional B. Braun Melsungen AG 18
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