Presentation at RAPS Regulatory Convergence about EU medical devices and IVD regulations' regulation of medical devices supply chain

1. How to implement the New Legal
Obligations of Economic Operators
in EU MDR
Erik Vollebregt
Axon Lawyers

2. Essential Tools for MDR / IVDR supply
chain
• MDR (Regulation 745/2017) and IVDR (Regulation 2017/746)
• Blue Guide 2016
• Commission interpretative document on placing on the market
• Decision 768/2008

3. EU supply chain regulation has evolved
(a lot) and that was totally expected

4. Where are you with your company’s
transition to MDR / IVDR?

5. 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

6. Division of responsibilities

7. Definitions regarding economic
operators (“MAID”)

8. New stuff in chapter II compared to
Decision 768/2008 re EOs
• Includes some provisions that create ‘new’ EOs, new liability and claims regulation
• Distance sale provision (art. 6)
• Claims (advertising) (art. 7)
• Prescriptive and policing independent AR, which is jointly and severally product liable (art.
11)
• Cases in which obligations of manufacturers apply to importers, distributors or other
persons (art. 14)
• Repacking / relabelling regime – medicinal products modelled but stricter than CJEU
Servoprax judgment
• 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)

9. 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

10. Manufacturer
• Article 10 obligations as elaborated in MDR /
IVDR
• New:
– UDI (art. 10 (7))
– All MFRs must be able to provide complete technical
documentation (OBL impact) (art. 10 (8))
– Risk management plan, PMCF plan, clinical evaluation,
QMS, vigilance described prescriptively in detail in
MDR / IVDR
– Provisions on product liability, insurance and
cooperation with authorities / claimants in product
liability cases

11. Authorised Representative
• AR become outsourced compliance officer at risk
for product liability
• Article 11 provides for mandatory included and
excluded items for AR mandate
– AR must terminate mandate if the MFR acts contrary
to its obligations under MDR/IVDR
– AR must inform CA if AR terminates mandate for MFR
non-compliance
• Article 12 provides for AR mandate handover
regime, preferably by means of 3 party
agreement

12. Importer
• Next important operator concerning compliance after manufacturer (“Blue Guide”)
• Art. 13: In order to place a device on the market, importers shall verify that:
a) the device has been CE marked and that the EU declaration of conformity of the
device has been drawn up;
b) a manufacturer is identified and that an authorised representative in accordance with
Article 11 has been designated by the manufacturer;
c) the device is labelled in accordance with this Regulation and accompanied by the
required instructions for use;
d) where applicable, a UDI has been assigned by the manufacturer in accordance with
Article 27
• Importers must label device with their details
• Importers have their own vigilance report and compliance monitoring requirements
• Definition of importer(s) in supply chain in practice problematic for many companies
– When does the ‘first placing on the market’ occur, and by whom?
– Definition of importer in other legislation (e.g. tax) irrelevant for MDR / IVDR
definition
– MDR / IVDR goods flow based, while tax law ownership/financial risk based

13. Distributor
• Largely the same obligations as IMP, but no obligation to label
• Before making a device available on the market, distributors shall verify
that all of the following requirements are met:
a) the device has been CE marked and that the EU declaration of conformity of
the device has been drawn up;
b) the device is accompanied by the information to be supplied by the
manufacturer in accordance with Article 10(11);
c) for imported devices, the importer has complied with the requirements set
out in Article 13(3);
d) that, where applicable, a UDI has been assigned by the manufacturer.
• Distributors may sample
• Importers have their own vigilance report and compliance monitoring
requirements
• Distributors are any reselling party in the supply chain other than MFR
and IMP

14. 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

15. Overlaps in comformity 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

16. Please do not end up here