STERILISATION AND THE MDR

SVN, Ede17 March 2017

Erik Vollebregtwww.axonadvocaten.nl

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

• 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 INew 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 - manufacturerArticle 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 - ARArticle 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 claimsSome 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 claimsWhat 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

Transitional period (3 years)

94 (2) grace period with certificate(4 years)

First certificate 94 (2) 2nd [entry into force of MDR to DoA + 2]

Last 94 (2) 2nd certificate [DoA -1 to DoA +4]

Entry into force

Date of application

DoA + 4 years

Transitional regime MDR

94 (3a) grace period for devices placed lawfully on the market by DoA (5 years)

DoA + 5 years

Lawfully made available under MDD or AIMDD

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THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500M +31 6 47 180 683

E erik.vollebregt@axonlawyers.com @meddevlegalB http://medicaldeviceslegal.com

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