This presentation discusses supply chain operators' obligations under the proposed EU medical devices regulation

1. MANAGE THE MAID
UNDER THE NEW
MEDICAL DEVICES
REGULATION
The new medical device regulations Capita Erik Vollebregt
Selecta: Impact for manufacturers www.axonadvocaten.nl
25 March 2013

2. Introduction + agenda
• Understanding how the roles of the economic operators are expected to
be defined in the revision of the MDD
• Clarifying autonomous responsibilities of operators in the supply chain of
medical devices
• How to implement overlapping responsibilities of economic operators in
supply and distribution agreements

3. Economic operators
The MAID:
• Article 2: „economic operators‟ means the manufacturer, the authorised
representative, the importer and the distributor;
Proposal implements strict supply chain control mechanism
• Blueprint from new new approach decision 768/2008
• As implemented in other specific instruments, e.g. toys and falsified
medicinal products directive
• Goal: enlist supply chain in market surveillance by imposing
autonomous obligations on the various stages of the supply chain

4. Definition of importer
Article 2 „importer‟ means any natural or legal person established within the
Union who places a device from a third country on the Union market;
„placing on the market‟ means “the first making available of a device, other
an investigational device, on the Union market”;
• placing on the market is neutral as to goods and services, online and
offline

5. Economic operators: importers
Must ensure that:
1. the appropriate conformity assessment procedure has been carried out
by the manufacturer;
2. an authorized representative in accordance with Article 9 has been
designated by the manufacturer;
3. the EU declaration of conformity and the technical documentation have
been drawn up by the manufacturer;
4. the device bears the required CE marking of conformity;
5. the device is correctly labeled and accompanied by the required
instructions for use and EU declaration of conformity;
6. a Unique Device Identification has been assigned;

6. Economic operators: importers
Must furthermore:
1. Be able to identify any economic operator to whom they have supplied
a device, any economic operator who has supplied them with a device
and any health institution or healthcare professional to whom they have
supplied a device for a period of five years;
2. Label the device with their contact details;
3. Take corrective action (a.o. recalls and report to authorities)
autonomously;
4. Engage in post-market surveillance (among other things report
complaints); and
5. Refuse to import devices of which he has reason to believe are not in
conformity with the requirements.

7. Definition of distributor
Article 2 „distributor‟ means any natural or legal person in the supply chain,
other than the manufacturer or the importer, who makes a device available
on the market‟
• any natural or legal person in the supply chain
• includes resellers, rental companies
• whether online or offline
• that makes a device available on the market
• “any supply of a device, other than an investigational device, for
distribution, consumption or use on the Union market in the
course of a commercial activity, whether in return for payment or
free of charge”

8. Economic operators: distributors
Must verify that:
1. the product bears the required CE marking of conformity;
2. the product is accompanied by the information to be supplied by the
manufacturer;
3. the manufacturer and, where applicable, the importer have complied
UDI and importer labeling requirements

9. Economic operators: distributors
Must furthermore:
1. ensure that, while a device is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the general
safety and performance requirements;
2. Label the device with their contact details;
3. Take corrective action (among other things undertake recalls and report
to authorities) autonomously;
4. Engage in post-market surveillance and vigilance (i.e., report
complaints)

10. Overview
Verify compliance Verify compliance
Supplier Manufacture
Importer Distributor
r
End
User
Post market surveillance and vigilance
Regulatory compliance of device

11. With such supply chain duties, do
we still need authorised reps?
Yes, AR must at least:
1. keep the technical documentation, the EU declaration of conformity
and, if applicable, a copy of the relevant certificate including any
supplement issued at the disposal of competent authorities for the
applicable period;
2. in response to a reasoned request from a competent authority, provide
that competent authority with all the information and documentation
necessary to demonstrate the conformity of a device;
Notably only AR is „allowed and required‟ to terminate the mandate if the
manufacturer acts contrary to his obligations under this Regulation.

12. Don’t forget to control suppliers
and subcontractors upstream
Article 8 (5) MDR - essentially no changes
Typical means of control is quality agreement
• EN ISO 13485 (management review and purchasing controls)
• Annex VIII, 3.2 (b) MDR
• “where the design, manufacture and/or final inspection and testing
of the products, or elements thereof, is carried out by another
party, the methods of monitoring the efficient operation of the
quality management system and in particular the type and extent
of control applied to the other party”
Control has to enable manufacturer to meet QMS goals as well as PMS
and vigilance obligations
• Account for unannounced inspections at subcontractors / suppliers

13. Don’t forget to control suppliers
and subcontractors upstream
• Manufacturer to
• Issue Subcontrator SOP / Quality Agreement
• criteria for level of control for category of part subcontracted
• criteria of level of evidence to be provided by subcontractor
• (ISO certificate, DoC, Design, Verification documentation,
documentation on changes)
• (periodic) evaluation of part
• (periodic) evaluation of subcontractor
• Issue Subcontractor agreement template
• Include subcontractors in internal audit program
• Always remember that subcontractors are not subject to same regulatory
requirements as manufacturer

14. Criticism on supply chain regs
COCIR:
• “several of the described tasks overlap and thus add unnecessary administrative
burden with no obvious benefit for the patients.”
• “COCIR suggests that the importer obligations should only apply in situations
where there is no organisational or legal relation (contract) between the
manufacturer and the importer and the manufacturer has appointed an
Authorised Representative in the EU. “
Eucomed:
“It is absolutely essential that the overlapping obligations and responsibilities of
different economic operators be clarified in the areas of device registration, vigilance
reporting and market surveillance. The definition of clear roles and responsibilities for
economic operators is not only critical to the functioning of the system, it is critical to
the way the supply chain to hospitals and patients work. If not done correctly, it could
have catastrophic effects on certain operators and SMEs within the supply chain,
effectively closing their businesses overnight and risking unavailability or increased
costs to hospitals and patients.”

15. Dealing with overlapping
responsibilities in supply chain
• regulatory compliance upstream
• If importer/distributor considers or has reason to believe that a
device is not in conformity, he shall not make the device available
on the market until it has been brought into conformity.
• Importer must do sample checks if appropriate regarding to risk
• autonomous post-market surveillance obligations
• If reason to believe that a device is not in conformity: immediately
inform the manufacturer and make sure that the necessary
corrective action to bring that device into conformity, withdraw or
recall it, if appropriate, is taken
• immediately forward to manufacturer “complaints or reports from
healthcare professionals, patients or users about suspected
incidents related to a device they have made available”)

16. Implementation of PMS in supply
chain
In addition to the usual provisions account for autonomous obligations on
the part of importers and distributors:
• implement mechanism for importer / distributor to check upstream
compliance and consequences on both sides
• ensure that manufacturer is always informed of autonomous action
undertaken – preferably consulted (implement RACI for autonomous
obligations)
• account for consequences of autonomous action
• manufacturer‟s reputation is on the line
• autonomous action impacts entire supply chain – ensure
appropriate liability and indemnities
• implement mechanism for exchange of PMS relevant information for
input in manufacturer processes

17. Qualified person
Manufacturer must have qualified person (even if manufacturer has AR!)
“within their organisation”
• unless SME custom-made devices manufacturer
QP responsibilities:
a) that the conformity of the devices is appropriately assessed before a
batch is released;
b) that the technical documentation and the declaration of conformity are
drawn up and kept up-to-date;
c) that the reporting obligations in accordance with Articles 61 to 66 are
fulfilled;
d) in the case of investigational devices, that the statement referred to in
point 4.1 of Chapter II of Annex XIV is issued.

18. Qualified person
QP qualification
• University level in natural sciences, medicine, pharmacy, engineering or
another relevant discipline, and at least two years of professional
experience in regulatory affairs or in quality management systems
relating to medical devices; OR
• five years of professional experience in regulatory affairs or in quality
management systems relating to medical devices
What do we know?
• Function may be outsourced
• Not the same autonomous obligations as AR (terminate / notification) but
is “responsible” – only to manufacturer or also to authorities?
• What is a batch? Depends on context and is 1 or more devices

19. Qualified person
What should an outsourced QP contract contain (from manufacturer
perspective)? At least:
• service level / availability
• RACI scheme for what is expected on top of “being responsible for” /
signing off on
• IP clause
• termination assistance
• clause to address suspension of services
• step in rights
• representation and warranties (a.o. as to qualification)
• confidentiality clause

20. Do these clauses work?

21. So … is this the final word?
• Looks like it – the method chosen for supply chain regulation is the
Decision 768/2008 system (articles R4 and R5) which has already been
implemented in CE directives (e.g. toys) so fully “new new approach”
compliant

22. Thanks for your attention
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal READ MY BLOG:
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