Presentation at the Dutch Sterilisation Association annual meeting about how the new EU Medical Devices Regulation affects the sterilisation industry specifically.

1. STERILISATION
AND
THE MDR
SVN, Ede
17 March 2017
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• Sterilisation specifics
• Amended definitions
• SUD reprocessing
• HPD regime that ties into reprocessing
• UDI
• When are you a manufacturer and what are your obligations?
• When are you product liable?
• Parts & components

4. • Medical devices
industry faces biggest
regulatory game
changers in EU since
decades
• Get it right or get it
wrong – mistakes will
impact your company
severely

5. MDR: gap assessment, impact
assessment, implementation

6. Manufacturer?
The MDR provides for a number of ways that a sterilisation services
provider becomes a manufacturer:
• Modification of device (article 16)
• Reprocessing (e.g. for third parties) (article 17)
• Placing on the market / using non-CE marked products for sterilisation,
disinfecting or cleaning of devices
Being a manufacturer under the MDR has consequences (see article 10)

7. When does a sterilisation services
provider become manufacturer?
Article 16 - Cases in which obligations of manufacturers apply to importers,
distributors or other persons
• Article 16 (1) (c) modifications in such a way that compliance with the
applicable requirements may be affected
• Article 16 (2) (b) In the case of devices placed on the market in sterile
condition, it shall be presumed that the original condition of the device is
adversely affected if the packaging that is necessary for maintaining the
sterile condition is opened, damaged or otherwise negatively affected by
the repackaging.

8. When does a sterilisation services
provider become manufacturer?
Article 17 Single-use devices and their reprocessing
• If allowed by the member state (article 17 (1))
• Any natural or legal person who reprocesses a single-use device to
make it suitable for further use within the Union shall be considered to
be the manufacturer of the reprocessed device and shall assume the
obligations incumbent on manufacturers laid down in this Regulation,
which include obligations relating to the traceability of the reprocessed
device in accordance with Chapter III of this Regulation. The
reprocessor of the device shall be considered to be a producer for
the purpose of Article 3(1) of Directive 85/374/EEC. (article 17 (2))
• Member States may choose to apply the [reprocessing requirements]
also as regards single-use devices that are reprocessed by an external
reprocessor at the request of a health institution, provided that the
reprocessed device in its entirety is returned to that health institution and
the external reprocessor complies with the [reprocssing]
requirements. (article 17 (4))

9. When does a sterilisation services
provider become manufacturer?
As regards single-use devices that are reprocessed and used within a
health institution, Member States may decide not to apply all of the rules
relating to manufacturers' obligations laid down in the MDR provided that
they ensure that:
• safety and performance of the reprocessed device is equivalent to that
of the original device and the requirements for HPDs (article 5 (5))
• the reprocessing is performed in accordance with CS
• Also applies in case of single-use devices that are reprocessed by an
external reprocessor at the request of a health institution, provided that
the reprocessed device in its entirety is returned to that health institution
and the external reprocessor complies with the above requirements
• Unclear if it applies to health institutions reprocessing for each
other.

10. When does a sterilisation services
provider become manufacturer?
Article 2 (1) – definition of medical device expanded:
Placing these products on the market means that the company becomes a
medical devices manufacturer

11. Core article of MDR: article 10
(gen. obligations manufacturer) (1)
1. designed and manufactured in accordance with the requirements of this
Regulation
2. establish, execute, maintain and document a system for risk
management as described in Section 1a in Annex I
3. conduct a clinical evaluation in accordance with the requirements set
out in Article 49 and Annex XIII, including post-market clinical follow-up
4. draw up and keep up to date the technical documentation which shall
allow assessment of the conformity of the device with the requirements
of this Regulation. The technical documentation shall include the
elements set out in Annexes II and IIa.
5. custom-made devices: draw up, keep up to date and keep available to
competent authorities documentation pursuant to Section 2 of Annex XI
6. draw up an EU declaration of conformity in accordance with Article 17,
and affix the CE marking of conformity in accordance with Article 18
7. comply with the obligations related to the UDI system
8. comply with registration obligations

12. Core article of MDR: article 10
(gen. obligations manufacturer) (2)
9. keep the technical documentation, the EU declaration of conformity
and, if applicable, a copy of the relevant certificate including any
amendments and supplements, available to the competent authorities
for at least ten years after the last device covered by the declaration of
conformity has been placed on the market (15 for implantable devices)
10.Have and maintain QMS that takes standards and CS into account,
addressing the minimum requirements in the MDR
11.implement and keep up to date the post-market surveillance system
12.ensure that the device is accompanied by the information to be supplied
in accordance with Annex I in an official Union language(s) determined
by the Member State where the device is made available to the user or
patient
13.In case of non-conformity take the necessary corrective action to bring
device into conformity, withdraw it or recall it
14.have a system for recording and reporting of incidents and field safety
corrective actions as set out in MDR
15.Cooperate with authority in information requests for product liability
claims

13. Core article of MDR: article 10
(gen. obligations manufacturer) (3)
16.Where manufacturers have their devices designed and manufactured
by another legal or natural person the information on the identity of that
person shall be part of the information to be submitted in accordance
with UDI requirements.
17.have measures in place to provide sufficient financial coverage in
respect of their potential liability under Directive 85/374/EEC
proportionate to the risk class, type of device and the size of the
enterprise (without prejudice to more protective measures under
national law)

14. Reprocessing regime
New definition of reprocessing

15. Small changes in procedure packs
Presently article 12 MDD focuses on comptability, new article 22 (4) MDR
makes sterilisiation procedure according to manufacturer instructions
mandatory to be able to rely on article 22 MDR.

16. Essential safety & performance
requirements in Annex I
New section 11 on Infection and microbial contamination
New IFU requirement:

17. New IFU requirements in Annex I

18. Hospital produced devices
Article 5 (5) MDR – they have to meet Annex I requirements, so also for
sterilisation
“With the exception of the relevant general safety and performance
requirements set out in Annex I, the requirements of this Regulation shall
not apply to devices, manufactured and used only within health institutions
established in the Union, provided that all of the following conditions are
met […]:
• (e) (iii) a declaration that the devices meet the general safety and
performance requirements set out in Annex I to this Regulation and,
where applicable, information on which requirements are not fully
met with a reasoned justification therefor,”

19. UDI for reusable devices
UDI – Annex VI part C

20. UDI for reusable devices

21. UDI for procedure packs

22. Liability and NCA facilitating
liability claims - manufacturer
Article 10 (16) MDR: “Natural or legal persons may claim compensation for
damage caused by a defective device in accordance with applicable Union
and national law.
Proportionate to the risk class, type of device and the size of the enterprise,
manufacturers shall have measures in place to provide sufficient financial
coverage in respect of their potential liability under Directive 85/374/EEC,
without prejudice to more protective measures under national law.”
• “Sufficient financial coverage proportionate to risk class, type and size of
enterprise”
• How to interpret this reliably and predictably? How is size of the
enterprise relevant for example (PIP was a small company)?
• “Without prejudice to more protective measures under national law”
• What can those be? They cannot provide for anything that
detracts from the useful effect of Directive 85/374

23. Liability and NCA facilitating
liability claims - AR
Article 11 (5) MDR / IVDR: “[…] where the manufacturer is not established
in any Member State, and has not complied with the obligations laid down
in Article 10 MDR/IVDR, the authorised representative shall be legally liable
for defective devices on the same basis as, jointly and severally, with the
manufacturer.
• Also in case the manufacturer misled the AR?
• “has not complied” – where and by whom is this determined?
• This will lead to a situation in which ARs will be even more trigger happy
to terminate agreements and manufacturers will have difficulties
engaging a new one
• AR agreements will be more and more sources of dispute

24. NCA facilitating liability claims
Article 10 (14) 2nd last para MDR / IVDR: “If a competent authority
considers or has reason to believe that a device has caused damage, it
shall, upon request, facilitate the provision, of the information and
documentation referred to in the first sub-paragraph to the potentially
injured patient or user and, as appropriate, the patient's or user's successor
in title, the patient's or user's health insurance company or other third
parties affected by the damage caused to the patient or user, without
prejudice to the data protection rules and, unless there is an overriding
public interest in disclosure, without prejudice to the protection of
intellectual property rights. The competent authority need not comply with
this obligation where disclosure of the information referred to in the first
subparagraph is ordinarily dealt with in the context of legal proceedings.”

25. NCA facilitating liability claims
Some practical comments:
• “potentially injured” – what does that mean?
• ”caused damage” – broader than by a defective device?
• What information? “all the information and documentation necessary to
demonstrate the conformity of the device”, information regarding vigilance
and corrective action – non-conforming is not necessarily defective in the
meaning of Directive 85/374
• To whom? Basically everyone ‘affected by the damage caused to the patient
or user’ – that’s a broad class of persons and entities (this could have been
used in the Guidant pacemaker and ICD case (C-503/13) for example)
• Except if
• Data protection, except if public interest in disclosure (balance of
interests) – unpredictable and easily influenced, and what is the public
interest in a private liability claim?
• Intellectual property – what does an NCA know about this?
• Disclosure of the information is ordinarily dealt with in the context of
legal proceedings – it basically always is in liability suits

26. Liability and NCA facilitating
liability claims
What does all of this mean for the market?
• Costs – insurance companies will be the laughing third party here
• More protection of patients? No, they could always sue for damage
resulting from defective devices and the NCAs’ facilitation will invoke
evasive manoeuvres all over the place, because the NCA would likely
see the information that the claimant receives
• Does it solve PIP type issues with manufacturer going bankrupt? No,
because insurance policies expire typically when a company goes
bankrupt

27. Third party parts & components
Article 23 MDR: “1. Any natural or legal person who makes available on the
market an article intended specifically to replace an identical or similar
integral part or component of a device that is defective or worn in order to
maintain or re-establish the function of the device without changing its
performance or safety characteristics or its intended purpose, shall ensure
that the article does not adversely affect the safety and performance of the
device. Supporting evidence shall be kept available to the competent
authorities of the Member States.
2. An article that is intended specifically to replace a part or component of a
device and that significantly changes the performance or safety
characteristics or the intended purpose of the device shall be considered
as a device and shall meet the requirements laid down in this Regulation.

28. Third parties: parts & components
• Non-OEM replacement parts and components must have supporting
evidence that they do not adversely affect the safety and performance of
the device
• Non-OEM enhancement parts are devices
• How will that work in practice? – accessory type evaluation?
• Is manufacturer obliged to development of supporting evidence for
competing non-OEM parts/components?
• Printer cartridge competition law cases

29. National implementation of
MDR/IVDR
• Many legal obligations will follow from national implementation of MDR
• E.g. national choices on fines and costs of surveillance
• Reprocessing allowed or not?
• Outsourced reprocessing allowed or not?
• Types of devices for hospital production?
• Require custom made devices manufacturers to submit lists of
devices made available
• Require HCPs and institutions to store UDI of implants
• Implementation of clinical trial provisions (e.g. require EU
representative appointment or not)
• Etc.

30. EU secondary law to implement /
amend MDR
• Common specifications for reprocessing

31. Entry
into
force
Date of
application
DoA
+ 4
years
Transitional regime MDR
DoA +
5
years

33. 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