MEDICAL DEVICE POST MARKET SURVEILLANCE AND VIGILANCE Informa Medical Device Post Market Surveillance and Vigilance 27 February 2013 Erik Vollebregt www.axonadvocaten.nl
Transcript
1. MEDICAL DEVICE POST MARKET SURVEILLANCE AND VIGILANCEInforma
Medical Device Post Market Erik VollebregtSurveillance and
Vigilance www.axonadvocaten.nl27 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 operatorsThe 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 importerArticle 2 importer means any natural
or legal person established within theUnion who places a device
from a third country on the Union market;placing on the market
means the first making available of a device, otheran
investigational device, on the Union market; placing on the market
is neutral as to goods and services, online and offline
5. Economic operators: importersMust 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: importersMust 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); and5. Refuse
to import devices of which he has reason to believe are not in
conformity with the requirements.
7. Definition of distributorArticle 2 distributor means any
natural or legal person in the supply chain,other than the
manufacturer or the importer, who makes a device availableon 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: distributorsMust 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: distributorsMust 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, dowe 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 themanufacturer
acts contrary to his obligations under this Regulation.
11. Criticism on supply chain regsCOCIR: 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
ofdifferent economic operators be clarified in the areas of device
registration, vigilancereporting and market surveillance. The
definition of clear roles and responsibilities foreconomic
operators is not only critical to the functioning of the system, it
is critical tothe way the supply chain to hospitals and patients
work. If not done correctly, it couldhave catastrophic effects on
certain operators and SMEs within the supply chain,effectively
closing their businesses overnight and risking unavailability or
increasedcosts to hospitals and patients.
12. Dealing with overlappingresponsibilities 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 SurveillanceProvisions 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 SurveillancePost Market Surveillance as we know
it will be pro-actively laid down in themanufacturers 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 manufacturers 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 supplychainIn addition to the
usual provisions account for autonomous obligations onthe 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 manufacturers 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 attentionErik VollebregtAxon LawyersPiet
Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M
+31 6 47 180 683E [email protected]@meddevlegal READ
MY BLOG:B http://medicaldeviceslegal.com
http://medicaldeviceslegal.com