EU MDR Implementation Strategies Virtual Workshop


    • Tuesday, February 4, 2020
      11:00 AM  -  11:05 AM
      Welcome and Introductions
      11:05 AM  -  11:35 AM
      Economic Operators
        • How can large manufacturers handle the various verifications the manufacturer, importer and distributor need to perform and avoid duplication? (related to MEDTECH Europe document)
        • IS "placing on the market" and "making available" triggered by PHYSICAL ownership AS WELL as legal ownership?
        • Are 3rd Party logistics providers (e.g. Healthlink, Rhenus, UPS) who are Fulfillment Service Providers also distributors?
        • Challenges with the point of "placing on the market" for capital equipment (and devices which must be installed) - who then is the importer? Who is the distributor?
        • Should Economic Operators be managed through the Supplier Management process within the QMS (ISO 13485:2016 clause 7.4)?

      11:35 AM  -  11:50 AM
      Technology Spotlight
      11:50 AM  -  1:20 PM
      Systems and Procedure Packs
      • Art 22 requirements - procedure packs - including when is a PP a PP and when is it a system?  BUDI assignment, UDI/labeling requirements
      • Accessories, spare parts, compatible devices
      • When is it placed on the market? (Impact of this on determining who is an importer and hence influence on definition of other actors in the supply chain perhaps as economic operators)
      • Practical examples
      1:20 PM  -  1:35 PM
      1:35 PM  -  2:20 PM
      Labeling & IFU (GSPR 23)
      • Implementing labeling requirements to meet MDR requirements, such as:
        • Overview of changes
        • For implants, quantitative info on materials - how detailed? How avoid giving away IP? (Different labels for different regions maybe, and configuration/operational issues with that)
        • Listing hazardous substances - how much details? Can we just use the CAS #?
        • Clinical benefits - how much detail?
        • GSPR 14.7 - disposal - can I just say "dispose of per local hospital requirements?" Yes/No? In what circumstances? What else do I need to do?
        • How to refer to the SSCP - is a weblink to Eudamed enough? what if eudamed is not ready and the weblink doesn't work?
        • Lay user considerations
        • Specify needed user training? Can i just say "users should be board certified interventional cardiologists? When is that sufficient? when is it not? What do i need to do if it's not? Particular requirements regarding Annex XVI devices for implants in this regard per CS
        • What  warnings/precautions go on the label? how do I decide?
        • GSPR 23.1 requirements - website and considerations (cybersecurity, GDPR?, translation, elabeling regulation 207/2012?) How do I decide what S&P info goes on the website?
        • Sterile packaging requirements (GSPR 23.3)
        • Status of standards and symbols
      2:20 PM  -  3:05 PM
      Implant Card (Article 18)

      Article 18 and MDCG 2019-7 requirements, including:

      • Size requirements (MDCG)
      • Type vs model? (MDCG)
      • Art 18a vs 18 b thru d - the latter on website - requirements (translation, GDPR, elabeling 207/2012?)
      3:05 PM  -  3:30 PM
      Q&A and Wrap-up
    • Wednesday, February 5, 2020
      11:00 AM  -  11:05 AM
      Welcome and Introductions
      11:05 AM  -  12:35 PM
      Clinical Evaluation
      "How to" under MDR
      12:35 PM  -  12:50 PM
      Technology Spotlight
      12:50 PM  -  1:35 PM
      Software under MDR
      • Rule 11 and classification (embedded in device, standalone, apps) - examples/case studies -
      • status COCIR and related guidances
      • Economic operators (importers, distributors) - Google Play, Apple store etc
      • Art 6 - cloud based services - examples/challenges
      1:35 PM  -  2:20 PM
      Hazardous materials
      • Getting the needed information? From suppliers? Testing?
      • Strategy for testing (how ensure all chemical stested? Ot risk based approach? how make sure the latter is robust?
      • finding a suitable test house?
      • managing the data
      • doing the calculations? At the article level? What is an article? (every part?) Is the BoM sufficiently detailed? If not, what can I do?
      2:20 PM  -  2:35 PM
      2:35 PM  -  3:20 PM
      Assignment of Basic UDI-DI
      • ​Grouping into families - considerations? (e.g., Using CND, impact on TD set-up and NB sampling if any, impact on SSCP; certs, DoC, etc.)
      3:20 PM  -  4:05 PM
      Article 117 and drug device combination products
      • Examples of products which fall under MDR vs under the Drug regulations
      • Can we use Art 22 of MDR (procedure packs) to include medicines and medical devices? Pros and Cons
      • How will the NB review of such combination product work?
      4:05 PM  -  4:30 PM
      Q&A and Wrap-Up
    • Thursday, February 6, 2020
      11:05 AM  -  11:50 AM
      Article 120(3)- Strategies for addressing the unknowns around what product changes can be made...
      • Strategies on how to deal with ambiguity of what changes can be made in soft transition
      11:50 AM  -  12:35 PM
      • PMS under MDR
        • Practical implementation
        • PSUR creation
        • Timing/content (including usage, patient population)
        • Getting the Information  needed
        • Defining roles and responsibilities between departments/functions
        • PROCESS for Assessing/Analyzing the data and drawing conclusions, holistically, across various data sources
        • Connecting with other plans and reports in the QMS; 
        • Timing and connection with CER (per class)
      • Vigilance reporting
        • new definitions
        • new timelines
        • managing info from EOs
        • changes to process/software
        • reporting thru Eudamed
      • Maintaining responsibilities after product obsolescence (implants, capital equipment, and in general)
      12:25 PM  -  1:00 PM
      Art 88 - Trend Reporting
      1:00 PM  -  1:45 PM
      • Status/technical details
      • What to do if Eudamed not ready - EO registration, device registration, clinical investigations, vigilance, etc.
      • Planning/preparing - what can MFR do now


      1:45 PM  -  2:00 PM
      2:00 PM  -  2:45 PM

      2:45 PM  -  3:30 PM
      First experiences with NB MDR audits
      • Differences from MDD, MDSAP, ISO 13485
      • Focus areas
      • Depth
      • Sampling of class lia and lib
      • Auditing EO; auditing of manufacturing; auditing of risk management; auditing of eudamed requirements
      • Lessons learned
      3:30 PM  -  4:15 PM
      General Discussion - Notified Body/Competent Authorities
      An opportunity for audience members to ask or anonymously submit questions