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![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 regulated distributors ex art. 14 MDR / IVDR as a
result of the services they provide](https://image.slidesharecdn.com/medtechsummiteconomicoperators2018-180614104552/85/Economic-operators-under-the-MDR-and-IVDR-12-320.jpg)
Uploaded byErik Vollebregt
Economic operators under the MDR and IVDR
The document discusses the responsibilities and compliance obligations of economic operators in the medical device supply chain under the MDR and IVDR regulations. It outlines the distinctions between EEA and third countries, emphasizes the importance of post-market surveillance, and highlights the evolving role of authorized representatives and fulfillment houses. Additionally, it addresses potential impacts of Brexit on regulatory frameworks and the need for manufacturers to adapt their operations accordingly.
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Economic operators under the MDR and IVDR
- 1. MDR / IVDR ECONOMIC OPERATORS MedTechSummit 11 June 2018 Erik Vollebregt www.axonadvocaten.nl
- 2. Essential Tools forMDR / IVDR supply chain • MDR / IVDR • Blue Guide 2016 • Commission informative notice on placing on the market • Decision 768/2008 (rumors that it may be revised) • CAMD guidance (in the works)
- 3. Where does thisapply?
- 4. Where does thisapply? • Note: • EEA is “Union” for the purpose of the Blue Guide • Turkey, Switzerland and – possibly after March 2019 the UK – 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 and IVDR relating to economic operators (e.g. placing on the market, importer and AR)
- 5. Supply chain obligations •Each link in the supply chain gets the responsibility to check compliance of the previous one • Review autonomous general obligations of importers and distributors (articles 13-14 MDR / IVDR), e.g. • verify compliance of the device, • inform competent authority of non-compliance of the device • implement corrective action • amend contracts accordingly
- 6. Supply chain controls:chapter II Manufacturer Importer Distributor End User Post market surveillance and vigilance Regulatory compliance of device Verify compliance Verify compliance Supplier Unannounced NB inspections Overlap Overlap Authorised Representative
- 7. • Name ondevice • 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
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- 11. New stuff inchapter II compared to Decision 768/2008 re EOs • Includes some provisions that create ‘new’ EOs, new liability • Cases in which obligations of manufacturers apply to importers, distributors or other persons (art. 14) • Repacking / relabeling regime – medicinal products modelled but stricter than CJEU Servoprax judgment • AR jointly and severally product liable (art. 11) • PRRC (art. 15) • Reprocessing (art. 17) • 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)
- 12. New stuff inBlue 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 regulated distributors ex art. 14 MDR / IVDR as a result of the services they provide
- 13. Blue Guide onfulfilment houses They may be economic operators when their activities go beyond those of normal parcel service providers:
- 14. OBL and virtualmanufacturing • MDR and IVDR require OBLs and virtual manufacturers to start function more like a true full blown manufacturer • MHRA guidance “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” • Each manufacturer must the full technical documentation for any product they place on the market under their name and fully integrate it in their QMS • If virtual manufacturer does not hold the rights related to product design, the NB and CA may accept a technical file with redacted proprietary information as long as the redacted information is not essential for conformity assessment / compliance. Redactions should be as limited as possible • Requirements for contract with OEM • Notfiied body Dekra has recently sent its customers a detailed letter with expections for virtual manufacturers
- 15. Major overlaps inEO 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
- 16. Overlaps in conformityobligations 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
- 17. Review your distribution agreements •Good clause / bad clause? • Hint: drafted in the assumption that the distributor does not have any autonomous obligations
- 18. CAMD guidance tofollow on economic operators • CAMD will produce guidance on the regulatory whats and hows
- 19. HPRA GDP guidance •MDR / IVDR taken into account • Nothing shocking that does not follow from GDP for MDR / IVDR • Nice overview of what HPRA expects in a distribution agreement
- 20. #Brexit • Wild cardbecause final scenario as yet totally unclear - current options: • “no deal” / hard Brexit • Governments have started to tell companies to prepare for this • Some kind of ‘deal’ (whatever it is) • Mutual recognition agreement • Trade agreement of sorts • UK accedes to EEA Treaty • UK enters into customs union • Brexit reversal before or after Brexit cut-off date • Unlikely but theoretically possible • After cut-off date • art. 49 (re-) application for EU membership
- 21. #Brexit preparations • Consequences foreconomic operators (unless the instrument between UK and EU provides differently) 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 (March 2019) • UK may well not implement MDR and IVDR post-Brexit so planning on UK having notified bodies is an unsure bet • Both third countries that have notified bodies (CH and TR) committed to implement full devices acquis and EU cannot accept less
- 22. www.axonlawyers.com THANKS FOR YOURATTENTION 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
- 23. Bonus slides retransition plan
- 24. If I askcompanies about their transition plan, they mostly answer either: