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

1. MANAGING NEW
REQUIREMENTS
FOR EO REGIME
Q1 MDR 2019
17 July 2019
Erik Vollebregt
www.axonadvocaten.nl

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. 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. Economic operator territorial
scope

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. Where does this apply?

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. • 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. 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. 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. Obligations economic operators

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. Division of responsibilities
• Agreements in supply chain should
account for manufacturer’s interests
regarding each line in this diagram

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. 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. Economic operators resource
sharing within company

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. What resources can be shared in
corporate group with internal EOs?

19. Authorised representative

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. 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. PRRC

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. Brexit

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. #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. Third party parts, components and
repacking/relabeling

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. 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. 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. 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. Bonus slides on EO agreement
drafting and negotiation

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. 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. 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. 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. 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. 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. 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. 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. Review your distribution
agreements
• Good clause / bad clause?
• Hint: drafted in the assumption that the distributor does not have any
autonomous obligations