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Managing New Requirement for Economic Operator Regime Slide 1 Managing New Requirement for Economic Operator Regime Slide 2 Managing New Requirement for Economic Operator Regime Slide 3 Managing New Requirement for Economic Operator Regime Slide 4 Managing New Requirement for Economic Operator Regime Slide 5 Managing New Requirement for Economic Operator Regime Slide 6 Managing New Requirement for Economic Operator Regime Slide 7 Managing New Requirement for Economic Operator Regime Slide 8 Managing New Requirement for Economic Operator Regime Slide 9 Managing New Requirement for Economic Operator Regime Slide 10 Managing New Requirement for Economic Operator Regime Slide 11 Managing New Requirement for Economic Operator Regime Slide 12 Managing New Requirement for Economic Operator Regime Slide 13 Managing New Requirement for Economic Operator Regime Slide 14 Managing New Requirement for Economic Operator Regime Slide 15 Managing New Requirement for Economic Operator Regime Slide 16 Managing New Requirement for Economic Operator Regime Slide 17 Managing New Requirement for Economic Operator Regime Slide 18 Managing New Requirement for Economic Operator Regime Slide 19 Managing New Requirement for Economic Operator Regime Slide 20 Managing New Requirement for Economic Operator Regime Slide 21 Managing New Requirement for Economic Operator Regime Slide 22 Managing New Requirement for Economic Operator Regime Slide 23 Managing New Requirement for Economic Operator Regime Slide 24 Managing New Requirement for Economic Operator Regime Slide 25 Managing New Requirement for Economic Operator Regime Slide 26 Managing New Requirement for Economic Operator Regime Slide 27 Managing New Requirement for Economic Operator Regime Slide 28 Managing New Requirement for Economic Operator Regime Slide 29 Managing New Requirement for Economic Operator Regime Slide 30 Managing New Requirement for Economic Operator Regime Slide 31 Managing New Requirement for Economic Operator Regime Slide 32 Managing New Requirement for Economic Operator Regime Slide 33 Managing New Requirement for Economic Operator Regime Slide 34 Managing New Requirement for Economic Operator Regime Slide 35 Managing New Requirement for Economic Operator Regime Slide 36 Managing New Requirement for Economic Operator Regime Slide 37 Managing New Requirement for Economic Operator Regime Slide 38 Managing New Requirement for Economic Operator Regime Slide 39 Managing New Requirement for Economic Operator Regime Slide 40 Managing New Requirement for Economic Operator Regime Slide 41
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Managing New Requirement for Economic Operator Regime

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Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019

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Managing New Requirement for Economic Operator Regime

  1. 1. MANAGING NEW REQUIREMENTS FOR EO REGIME Q1 MDR 2019 17 July 2019 Erik Vollebregt www.axonadvocaten.nl
  2. 2. Agenda • Territorial scope of MDR / IVDR economic operator regulation • Who is economic operator? • Economic operators new stuff • Pooling of EO resources in corporate groups • Third parties: repacking/relabelling, parts & components • Authorised representative • Brexit • Bonus slides on EO agreement drafting and negotiation
  3. 3. EO status • With most of the technical documentation and QMS remediation over, companies turn to EO remediation and everybody is figuring this out at the moment • CAMD guidance promised but lacking as usual • No significant engagement with independent distributors seems to be happening in the market as far as I can see
  4. 4. Economic operator territorial scope
  5. 5. Essential Tools for MDR / IVDR supply chain • MDR / IVDR • Blue Guide 2016 • Commission informative notice on placing on the market • Decision 768/2008 (rumors that it will be revised)
  6. 6. Where does this apply?
  7. 7. Where does this apply? • Note: • EEA is “Union” for the purpose of the Blue Guide • Turkey, Switzerland and – possibly soon the UK after Brexit end March 2019 – are “third countries” which only count as Union if the instrument in place says so explicitly • Distinction between Union and third countries is relevant for key concepts in MDR relating to economic operators (e.g. placing on the market, importer and AR) • Turkey is implementing • Switzerland still in suspense about what the new Mutual Recognition Agreement will look like
  8. 8. • Does not make devices available on own behalf • Places non-imported devices on the market • Places imported devices on the market • Established in the Union • Makes devices available • Can be manufacturer (or not) under art. 16 conditions (branded distribution • May put devices into service Authorised Representative Manufacturer Importer Distributor Clearance, logistics and storage providers How does this apply? • Has general EO obligations (e.g. UDI) System integrator / procedure pack steriliser
  9. 9. How does this apply? Understanding of concepts of “placing on the market” and “making available” crucial for EO characterisation Placing on the market • first transfer of a device from the manufacturing stage into the Union distribution chain after final quality control release as finished goods (includes packaging or labelling); and • the device must be freely available for supply or final use within the Union supply chain (customs cleared and intent to distribute in Union) Making available • device must be supplied for distribution, consumption or use in the Union in the course of a commercial activity, either for payment or free of charge • Implies offer or agreement, physical handover not required
  10. 10. Challenges (just a few) • What the heck is placing on the market and making available? • How to set up the AR in view of arm’s length placement because of product liability risk? • Importer labelling – how, what, where? • How to equip/operationalise the PRRC? • What is ‘verification’ and ‘consider or have reason to believe’? • How to pool resources to be made available to an intra-group chain of EOs? Can AR and MFR share PRRC resource etc.? • How to cooperate between EOs on overlapping responsibilities? • How to work with EO obligations in soft transition periods (2020-2024 MDR and 2022-2024 IVDR) • Dealing with third parties that turn out to be importers or distributors (e.g. fulfilment houses – see Blue Guide) • Systems integrators / kitters / sterilisers awareness of EO obligations • The article 23 component manufacturer as new EO
  11. 11. Obligations economic operators
  12. 12. • Name on device • CE +DOC • GSPR • UDI • PRRC • Name on device • Check Eudamed • Register of complaints • Check DoC + cert • Assist with corr. action. • Safeguard storage conditions • Assist authorities • Not make available if conformity compromised • Forward complaints • Safeguard storage conditions • Assist with corr. action. • Assist authorities • Not make available if conformity compromised Authorised Representative Verify compliance: • CE +DoC • AR assigned • Labeling • UDI Verify compliance: • CE +DoC • IFU present • Importer details added • UDI Manufacturer Importer Distributor
  13. 13. Division of responsibilities • Agreements in supply chain should account for manufacturer’s interests regarding each line in this diagram
  14. 14. New stuff in chapter II compared to Decision 768/2008 re EOs • Includes some provisions that create ‘new’ EOs (system integrator and procedure pack assembler (art. 2 (35) MDR), new liability • Cases in which obligations of manufacturers apply to importers, distributors or other persons (art. 16) • Repacking / relabeling regime – medicinal products modelled but stricter than CJEU Servoprax judgment • AR jointly and severally product liable (art. 11) • PRRC (art. 15) • DOC to be updated continuously and translated in languages required by the Member State(s) in which the device is made available (art. 19) • Cases where parts / components suppliers must validate part / component or be manufacturer of device (art. 23)
  15. 15. New stuff in Blue Guide that is often overlooked • The role of fulfilment houses (FHs) as service provider to EOs (section 3.4) • If their activities “go beyond those of parcel service providers that provide clearance services, sorting, transport and delivery of parcels […] they should be considered as distributors and should fulfil the corresponding legal responsibilities.” • Many medical devices companies find that their FHs are not ‘neutral’ service providers but MDR regulated distributors ex art. 14 MDR as a result of the services they provide
  16. 16. Economic operators resource sharing within company
  17. 17. What resources can be shared in corporate group with internal EOs? • The EO regime • does not translate well to large companies that have multiple EOs under the same joint control • makes amending your supply chain contracts a good idea • Can a company pool resources between various EOs? • Yes, but EO concerned always remains responsible • Use internal quality agreements or QMS procedures to enable internal verification and audit • Make sure to establish entities/persons in EU where this is required • Some roles can be combined in one EU legal entity, some cannot and some require careful consideration (i.e. AR and any other role)
  18. 18. What resources can be shared in corporate group with internal EOs?
  19. 19. Authorised representative
  20. 20. Authorised representative • Big changes for authorised representatives, both ‘in-house’ and external • Implementation of AR MEDDEV • Prescriptive rules for AR mandate and contract – like notified bodies ARs are recruited into market surveillance • AR must provide information, cooperate in investigation and verify that appropriate conformity assessment procedure has been carried out by the manufacturer • AR must have person responsible for regulatory compliance • Problematic: • terminate the mandate if the manufacturer acts contrary to his obligations • In case of termination, notify CA and Notified Body of termination and reasons for termination
  21. 21. Authorised representative • Companies with internal AR wonder what the required level of non- compliance is for mandatory termination under article 11 (3) (h)? • Internal escalation and remediation process • Can also be used for external AR agreement
  22. 22. PRRC
  23. 23. PRRC requirements • Article 15 MDR: • Manufacturer must employ one • AR and/or micro/small undertaking should contract one • PRRC role can be shared between several persons • MDCG Guidance 2019-7: • PRRC for the manufacturer and AR cannot be the same person • PRRC for the AR must be located in the EU • PRRC qualifications must be proven by demonstrated member state equivalency • guidance provides a level of detail with regard to the cross-links between the manufacturer responsibilities under article 10 MDR/IVDR and the PRRC minimum responsibilities set out in article 15 (3) MDR/IVDR
  24. 24. Brexit
  25. 25. Brexit • Nobody has the answer in the UK and politics are all over the place • At present, uncertain whether no deal Brexit or not and if deal what it will look like • Halloween Brexit deadline now (31 October 2019) • Most MFRs do not have a solid Brexit plan in case of hard Brexit • Member states still caution companies to prepare for no deal scenario • Plan be can be ramping up production to build bridging stock • Ensure EU 27 notified body, AR and importer
  26. 26. #Brexit preparations • Consequences for economic operators (unless the instrument between UK and EU provides differently) in case of ‘hard’ Brexit because UK is no longer “Union” so • Manufacturer in UK is not in Union, needs importer and AR for EU • Importer and AR for EU purposes cannot be based there • UK can not / no longer have notified bodies • For current directives (AIMDD, MDD, IVDD) • For MDR and IVDR • Transition to EU27 NB before withdrawal date (end March 2019) • All CE certificates granted by UK notified bodies will be invalid in the EU per withdrawal date because European law ceases to apply and UK notifications of notified bodies become void • Unsure if CAMD orphaning procedure applies to this
  27. 27. Third party parts, components and repacking/relabeling
  28. 28. Third parties: parts & components Article 23 MDR / 20 IVDR: “1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the article does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available to the competent authorities of the Member States. 2. An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered as a device and shall meet the requirements laid down in this Regulation.
  29. 29. Third parties: parts & components • Non-OEM replacement parts and components must have supporting evidence that they do not adversely affect the safety and performance of the device • Standard of supporting evidence? Criterion presumes a validation • Is OEM obliged to cooperate in validation? • Non-OEM enhancement parts are devices • How will that work in practice? – accessory type evaluation? • Is manufacturer obliged to development of supporting evidence for competing non-OEM parts/components? • Printer cartridge competition law cases
  30. 30. Third parties: repacking & relabelling • Basically pharma repacking case law written down for devices • Strangely enough stricter regime than outcome of the EU Court Servoprax case (C-277/15) • Article 16 (2) MDR / 15 (2) IVDR: • Translation of IFU and other information and repacking do not make someone a manufacturer • Indicated person responsible for activity on the pack or accompanying document • Have notified body blessed QMS and vigilance for activity • But blessed under what standard / CS / criteria? • Reporting and mock-up to manufacturer and NCA for each time repacked / relabelled device is made available
  31. 31. Thanks for your attention! Erik Vollebregt Axon Lawyers Piet Heinkade 183 1019 HC Amsterdam T +31 88 650 6500 M +31 6 47 180 683 E erik.vollebregt@axonlawyers.com @meddevlegal B http://medicaldeviceslegal.com READ MY BLOG: http://medicaldeviceslegal.com
  32. 32. Bonus slides on EO agreement drafting and negotiation
  33. 33. Major overlaps in EO obligations for example in PMS and vigilance • Account for overlaps in your supply, distribution, agency, etc. agreements Post-Market Surveillance (PMS) & Vigilance EU MFR Non-EU MFR AR Importer Distributor Complaint communication within supply chain Keep register of complaints, non-conforming devices complaints, recalls, withdrawals Inform manufacturer, AR, importer about device non-conformity Vigilance System Vigilance Reporting2 Provide documentation demonstrating device compliance to Competent Authority (CA) Provide product samples free of charge to CA Provide information on serious risks of device to authorities Provide Notified Body with information on serious risk devices Implement FSCAs Cooperation with authorities on FSCAs
  34. 34. Overlaps in conformity obligations Device conformity MFR Non-EU MFR AR Importer Distributor QMS pursuant to MDR / IVDR (Article 10 (9)) Person responsible for regulatory compliance QMS according to Article 16 (3) 2nd subparagraph as applicable Ensure proper device storage and transport Conformity assessment including CE-certificate Verification of appropriate conformity assessment procedure Verify CE-marking Keep copy of CE-certificate UDI assignment Verify UDI assignment Draw up Technical Documentation and keep it available 10/15 years Verification of Technical Documentation availability Keep copy of Technical Documentation Draw up of Declaration of Conformity and keep it available 10/15 years Verification of availability of Declaration of Conformity Keep Declaration of Conformity available • More sets of overlaps like this, e.g. in labeling, UDI and (product) liability
  35. 35. What must be looked at in IMP agreement from MDR perspective? • Verification obligations • How to implement verification obligations? • Define when the IMP has considers or has reason to believe that a device is not in conformity with MDR requirements • Can MFR intervene / be informed before IMP notifies authorities of device presents a serious risk or is a falsified device? • Labeling and registration obligations • How will IMP label? (not obscure any information on the label provided by the manufacturer) – information exchange • Work with UDI and Eudamed • Safeguard transport and storage conditions • How will IMP do this? Consequences?
  36. 36. What must be looked at in IMP agreement from MDR perspective? • Register of complaints • IMP must keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints – how will this work in practice? • Corrective action of IMPs • When is there a serious risk that warrants IMP to notify Notified Body and CA? • What action will take IMP? What information must be given to MFR beforehand? What consequences if IMP is wrong in implementing corrective action?
  37. 37. What must be looked at in IMP agreement from MDR perspective? • Vigilance obligations of IMP and information sharing • Share with MFR complaints or reports from healthcare professionals, patients or users about suspected incidents - how will that be implemented and what is IMP confidential information? • DOC and certs on file • keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements – how does the information exchange work? • Cooperation with authorities • Importers shall cooperate with competent authorities, at the latter’s request, on any action taken to eliminate / mitigate – what information and cooperation with MFR?
  38. 38. What must be looked at in DIS agreement from MDR perspective? • General obligation – due care • DIS must act with due care in relation to the requirements applicable – what does this mean in terms of care vis-à-vis manufacturer? • Verification obligations • How to implement verification obligations? • Define when the DIS has considers or has reason to believe that a device is not in conformity with MDR requirements • Can MFR intervene / be informed before DIS notifies authorities of device presents a serious risk or is a falsified device? • Safeguard transport and storage conditions • How will IMP do this? Consequences?
  39. 39. What must be looked at in DIS agreement from MDR perspective? • Corrective action of DIS • When is there a serious risk that warrants DIS to notify Notified Body and CA? • What action will take DIS? What information must be given to MFR beforehand? What consequences if DIS is wrong in implementing corrective action? • Vigilance obligations of DIS and information sharing • Share with MFR and IMP complaints or reports from healthcare professionals, patients or users about suspected incidents - how will that be implemented and what is DIS confidential information?
  40. 40. What must be looked at in DIS agreement from MDR perspective? • Cooperation with authorities • Importers shall cooperate with competent authorities, at the latter’s request, on any action taken to eliminate / mitigate – what information and cooperation with MFR? • Registration obligations, traceability and UDI • How will MFR and DIS cooperate ‘to achieve an appropriate level of traceability of devices’ • National registration obligations (transfer of registrations etc)
  41. 41. Review your distribution agreements • Good clause / bad clause? • Hint: drafted in the assumption that the distributor does not have any autonomous obligations
  • TamikaMiranda

    Dec. 4, 2021
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    Feb. 20, 2020
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    Aug. 18, 2019

Presentation of new economic operator regime under the new EU Medical Devices and IVDs Regulations, delivered at the Q1 Medical Devices Regulation conference on 16 July 2019

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