NEW LEGAL OBLIGATIONS UNDER MDR AND IVDR

RMD2016, Prague7 November 2016

Erik Vollebregtwww.axonadvocaten.nl

Agenda

• Some of the “legal” 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

• General Data Protection Regulation and its interface with Annex I chapter 14 MDR / 13 IVDR

Claims

Article 5a MDR / IVDR

In the labelling, instructions for use, making available, putting into service and advertising of devices, it is prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety andperformance by:

(a) ascribing functions and properties to the product which the product does not have;(b) creating a false impression regarding treatment or diagnosis, functions or properties which the product does not have;(c) failing to inform of a likely risk associated with the use of the product in line with its intended purpose;(d) suggesting uses of the product other than those declared in the intended purpose when the conformity assessment was carried out.

Claims

Provisions apply not only to advertising but also to other materials and actions involving intended use:

• labelling, • instructions for use, • making available, • putting into service, and• advertising

Similar system as under Unfair B2C Commercial Practices Directive – look at concept of ‘commercial practice’ (“any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product”)

Claims

• What does “prohibited” mean?

• NCAs can enforce (fines and retraction / rectification)• Notified Body can write you up for a major non-conformity (e.g. if

the claim is made in the IFU or label)• Under EU advertising law it means that competitors have a direct

action in court in the member states

• Will need to see how this affects current wide differences between member states with regard to private enforcement of claims regarding medical devices

ClaimsWhat does it mean for the manufacturer?

• A lot easier for competitors to challenge claims in more places

• Need for careful vetting of supporting evidence in accuracy over time• • “failing to inform of a likely risk associated with the use of the product in

line with its intended purpose” is relevant for product liability as well (Art. 6 (1) Directive 85/374 defines a defect product as: ”when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b) the use to which it could reasonably be expected that the product would be put;”

• Tricky off-label use provision (“suggesting uses of the product other than those declared in the intended purpose”) – normally active suggestions / soliciting of off-label use is not allowed; how should we read “suggesting” in this context?

Authorised representative

• Big changes for authorised representatives, both ‘in-house’ and external• Implementation of AR MEDDEV• Prescriptive rules for AR mandate and contract – like notified bodies ARs

are recruited into market surveillance• AR must provide information, cooperate in investigation and verify that

appropriate conformity assessment procedure has been carried out by the manufacturer

• AR must have person responsible for regulatory compliance

• Problematic:

• terminate the mandate if the manufacturer acts contrary to his obligations

• In case of termination, notify CA and Notified Body of termination and reasons for termination

Authorised representative

The modalities of a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative and the incoming authorised representative (art. 10 MDR / IVDR)

This agreement shall address at least the following aspects:

(a) the date of termination and date of beginning of the mandates;(b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;(c) the transfer of documents, including confidentiality aspects and property rights;(d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports that may be incident related

Supply chain obligations

• Each link in the supply chain gets the responsibility to check compliance of the previous one

• Review autonomous general obligations of importers and distributors (articles 11-12 MDR / IVDR), e.g.

• verify compliance of the device, • inform competent authority of non-compliance of the device• implement corrective action

• amend contracts accordingly

Supply chain controls

Manufacturer Importer Distributor

EndUserPost market surveillance and vigilance

Regulatory compliance of device

Verify compliance Verify compliance

Supplier

Supplier

Subco

ntrac

tors

Unannounced NB inspections

Responsible person

• Looks like a pharma QP but isn’t• Manufacturers shall have available within their organisation at least one

person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices

• May be more; role(s) may be split over persons• Qualifications necessary in MDR / IVDR• Can you outsource the role?

• Unsure what “available within their organisation” means but SMEs and ARs are not required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

• Suggests that SMEs and ARs can outsource but bigger companies / non-ARs cannot

Liability and NCA facilitating liability claims - manufacturerArticle 8 (13) MDR / IVDR : “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 9 (4a) MDR / IVDR: “[…] where the manufacturer is not established in any Member State, and has not complied with the obligations laid down in Article 8 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 8 (9) 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 parties: parts & components

Article 21 MDR / 19 IVDR: “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

Third parties: repacking & relabelling• Basically pharma repacking case law written down for devices• Strangely enough stricter regime than outcome of the EU Court

Servoprax case (C-277/15)

• Article 14 (2) MDR / IVDR:

• Translation of IFU and other information and repacking do not make someone a manufacturer

• Indicated person responsible for activity on the pack or accompanying document

• Have notified body blessed QMS and vigilance for activity• Reporting and mock-up to manufacturer and NCA for each time

repacked / relabelled device is made available

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.

General Data Protection Regulation and its interface with Annex I chapter 14 MDR• Annex I chapter 14 MDR / 13 IVDR contains security rules in relation to

software (both embedded and stand alone)

• “14.2 / 13.2 For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured according to the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.”

• GDPR requires compliance by design and default for any device processing personal data

• If a device processes personal data (concerning health), it will have to conform to design principles under two different regulations

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

Transitional period (5 years)

Certificate issued before or during transtional period 87(2)

[entry into force of MDR to DoA + 2]

Entry into force

Date of application

DoA + 2 years

Transitional regime IVDR

87 (3a) grace period for devices placed lawfully on the market by DoA

(3 years)

DoA + 3 years

Lawfully made available under MDD or AIMDD

www.axonlawyers.com

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

READ MY BLOG:http://medicaldeviceslegal.com