1. MEDICAL DEVICE
POST MARKET
SURVEILLANCE AND
VIGILANCE
Informa Medical Device Post Market Erik Vollebregt
Surveillance and Vigilance www.axonadvocaten.nl
27 February 2013

2. Introduction + agenda
• Understanding how the roles of the economic operators are expected to
be defined in the revision of the MDD
• Examining new PMS obligations for various operators in the medical
devices supply chain as a result of the revision of the MDD
• How to implement overlapping responsibilities of economic operators in
supply and distribution agreements
• Clarifying autonomous responsibilities of operators in the supply chain of
medical devices

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
• 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. 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.

11. 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.”

12. 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”)

13. Post Market Surveillance
Provisions in
• Article 8 (6) Manufacturer must have and implement post market
surveillance plan
• Chapter VI of new MDR (Clinical evaluation and clinical investigations)
• Article 49: Manufacturers shall conduct a clinical evaluation in
accordance with the principles set out in this Article and Part A of
Annex XIII
• Annex XIII pre-market clinical evaluation and post-market clinical follow-
up
• Part A (pre) Clinical evaluation
• Part B Post Market Clinical Follow Up - includes PMCF plan

14. Post Market Surveillance
• Article 8 (6): “The post-market surveillance plan shall set out the process
for collecting, recording and investigating complaints and reports from
healthcare professionals, patients or users on suspected incidents related
to a device, keeping a register of non-conforming products and product
recalls or withdrawals, and if deemed appropriate due to the nature of the
device, sample testing of marketed devices. Part of the post-market
surveillance plan shall be a plan for post-market clinical follow-up in
accordance with Part B of Annex XIII. Where post-market clinical follow-
up is not deemed necessary, this shall be duly justified and documented
in the post-market surveillance plan.”
• Process must be implemented in supply chain

15. Post Market Surveillance
Post Market Surveillance as we know it will be pro-actively laid down in the
manufacturer‟s post market surveillance plan (Annex XIII part B):
• “Post-market clinical follow-up, hereinafter: PMCF, is a continuous
process to update the clinical evaluation referred to in Article 49 and Part
A of this Annex and shall be part of the manufacturer's post-market
surveillance plan. To this end, the manufacturer shall proactively collect
and evaluate clinical data from the use in or on humans of a device
which is authorised to bear the CE marking, within its intended purpose
as referred to in the relevant conformity assessment procedure, with the
aim of confirming the safety and performance throughout the expected
lifetime of the device, the continued acceptability of identified risks and
to detect emerging risks on the basis of factual evidence.”

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

17. Example clause that needs changing

18. So … is this the final word?
• Looks like it – method chosen for supply chain 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
• Powerful arguments necessary to convince Commission to depart from
system

19. 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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