STERILISATION AND THE MDR

SVN, Ede 17 March 2017

Erik Vollebregt www.axonadvocaten.nl

Agenda

• Sterilisation specifics

• Amended definition of MD

• SUD reprocessing

• Some of the “legal” related obligations:

• New claims article

• Authorised representative

• Supply chain: obligations of the others

• Responsible person

• Liability and NCA facilitating liability claims

• Third parties: repacking/relabelling, parts & components

• National implementation of MDR/IVDR

• 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

MDR: gap assessment, impact assessment, implementation

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)

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.

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))

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.

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

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

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

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)

Reprocessing regime

New definition of reprocessing

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.

Essential safety & performance requirements in Annex I New section 11 on Infection and microbial contamination

New IFU requirement:

New IFU requirements in Annex I

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,”

UDI for reusable devices

UDI – Annex VI part C

UDI for reusable devices

UDI for procedure packs

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

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

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.”

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

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

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.

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

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.

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

Entry

into

force

Date of

application

DoA

+ 4

years

Transitional regime MDR

DoA +

5

years

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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

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