Presentation at the MedTech Summit 2018 in Brussels concerning the new EU regulatory regime for economic operators in the supply chain of medical devices and IVDs

1. MDR / IVDR
ECONOMIC
OPERATORS
MedTech Summit
11 June 2018
Erik Vollebregt
www.axonadvocaten.nl

2. 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 may be revised)
• CAMD guidance (in the works)

3. Where does this apply?

4. Where does this apply?
• 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 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

8. Obligations economic operators

9. Division of responsibilities

10. Definitions regarding economic
operators (“MAID”)

11. New stuff in chapter 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 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

13. Blue Guide on fulfilment houses
They may be economic operators when their activities go beyond those of
normal parcel service providers:

14. OBL and virtual manufacturing
• 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 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

16. 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

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 to follow 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 card because 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 for economic 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 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

23. Bonus slides re transition plan

24. If I ask companies about their
transition plan, they mostly
answer either: