The EU Medical Devices Regulations – Impact on … · Council directive 93/42/EEC of 14 June 1993...

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The EU Medical Devices Regulations – Impact on distributors

Olivier MignoletAnnabelle Bruyndonckx

beMedTechGroot-Bijgaarden, 9 May 2017

© Simmons & Simmons LLP 2016. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.

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Purpose

Analyse the main changes brought by the Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR)

From the perspective of distributors of medical devices and IVD medical devices


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Agenda

Introduction

1. Distributors of (in vitro diagnostic) medical devices in the new EU legal framework

2. Cases in which obligations of manufacturers apply to distributors

3. Autonomous obligations of distributors

4. Advertising (in vitro diagnostic) medical devices in the EU

5. Relations between distributors and authorities

6. Distributors and liability

Conclusions

3© Simmons & Simmons LLP 2016. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.

Introduction


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Introduction

Today – Medical devices directives

Three Directives (“current directives”)

Council directive 93/42/EEC of 14 June 1993 concerning medical devices (“MDD”)

Council directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices (“AIMD”)

Directive 98/79EC of the European parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices (“IVDD”)


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Introduction

Tomorrow – Medical devices regulations

26 September 2012: two draft proposals (EU Commission)

Proposal for a regulation of the European Parliament and of the Council on medical devices, and amending directive 2001/83/EC, regulation (EC) 178/2002 and regulation (EC) 1223/2009(COM/2012/0542 final)

Proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices(COM/2012/0541 final)

5 April 2017: the European Parliament approved the Council position at first reading and instructed to arrange for the publication in the Official Journal of the European Union


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Introduction

Tomorrow – Medical devices regulations

5 May 2017: Publication of the regulations

Regulation (EU) 2017/745 of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU


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Introduction

Transitional period MDR and IVDR (recital 95)

“To allow economic operators, especially SMEs, notified bodies, Member States and the Commission to adapt to the changes introduced by this Regulation and to ensure its proper application, it is appropriate to provide for a sufficient transitional period for that adaptation and for the organisational arrangements that are to be taken.”

“However, certain parts of the Regulation that directly affect Member States and the Commission should be implemented as soon as possible”

MDR and IVDR transitional

period

Implementingacts


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Introduction

Transitional period: MDR and IVDR MDR (article 123), IVDR (article 113)

Entry into force (“EIF”) of both regulations takes place 20 days after their publication As of 25 May 2017

The regulations do not apply directly (“Application Date”):

MDR applies 3 years after EIF

IVDR applies 5 years after EIFExcept for some provisions (which apply earlier or later)


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Introduction

Transitional period: MDR and IVDR

Overview

MDR

IVDR

PUBLICATION DATE

05 MAY 2017

20 D

AYS

EIF

25 May 2017

APPLICATION DATE MDR(3 YEARS TRANSITION PERIOD)

26 MAY 2020

APPLICATION DATE IVDR(5 YEARS TRANSITION PERIOD)

26 MAY 2022


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Introduction MDR (article 123(3))

6 months after entry into force 26 November 2017Requirements on Notified Bodies,designation of Competent Authorities andestablishment of the Medical Device Coordination Group (MDCG)MDR (articles 35–50, 101 and 103)

12 months after entry into force 26 May 2018Cooperation among Competent AuthoritiesMDR (article 102)

3 years after entry into force or Not before 26 May 20206 months after publication thatEUDAMED is fully operationalVariety of regulations regarding EUDAMED and UDI Database are applicable(e.g. registration of manufacturers and Assignment of UDI)MDR (articles 29(1-3); Annex VI Part C and B, articles 31, 32 and 33(4))


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Introduction MDR (article 123(3))

18 months after publication that Not before 26 November 2021EUDAMED is fully operationalProducts and certificates on EUDAMEDMDR (articles 29(4), 56(5) and 123(3) let. e)

4 (MDR) or 2 (IVDR) years after 27 May 2024date of ApplicationMaximum period of validity of certificatesissued under current DirectivesMDR (article 120(2)), IVDR (article 110(2))

3 (IVDR) or 5 (MDR) years after 27 May 2025date of ApplicationMaking available of devices placed on themarket under current Directives(e.g. registration of manufacturers and Assignment of UDI)MDR (article 120(4)), IVDR (article 110(4))


1. Distributors of (in vitro diagnostic) medical devices in the new EU legal framework


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1. Distributors in the new EU legal framework

Distributors are acknowledged in the MDR / IVDR

Definitions MDR/IVDR (article 2 – definitions)

‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service

• ‘Making available on the market' means 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

• ‘Putting into service' means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose


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Other definitions MDR/IVDR (article 2 – definitions)

‘Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market

• ‘Placing on the market' means the first making available of a device, other than an investigational device, on the Union market

‘Manufacturer' means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark

• ‘Fully refurbishing' for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device


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Activities of distributors

Their activities are expressly addressed MDR (recital 28), IVDR (recital 26)

For the purpose of the Regulations, the activities of distributors should be deemed to include acquisition, holding and supplying of devices


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+ They are also “economic operators” MDR (article 2(35)), IVDR (article 2(28))

“Economic operator” means a manufacturer, an authorised representative, an importer, a distributor [or an assembler of systems or procedure packs]

Obligations incumbent to “economic operators” without further specification also apply to distributors


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Distribution – Key concepts MDR (article 2(27-29)), IVDR (article 2(20-22))

Placing on the market Making available on the market Putting into service

First making available of a device (other than an investigational device) on the Union market

Supply of a device (other than an investigational device)

For distribution, consumption or useon the Union market

In the course of a commercial activity

Whether in return for payment or free of charge

Making available of a device (other than an investigational device) on the Union market

To the final user As being ready for use

on the Union market

For the first time

For its intended purpose


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SupplierSub-contractor

Etc.Manufacturer Importer Distributor

End-user

Compliance of the device with the Regulations (pre-marketing)

Vigilance (post-marketing)

Third party

Verification Verification Supply

Involvement

Supply chain overview


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Supply chain overview MDR (article 25), IVDR (article 22)

Important role of the Unique Device Identification (UDI) throughout the entire supply chain

Allows identification and traceability of devices

Distributors and importers must co-operate with manufacturers /authorised rep. to achieve an appropriate level of traceability ofdevices

From manufacturer’s perspective, the UDI is regulated downstream(importers, distributors and users), but not upstream (suppliers,sub-contractors)




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Overview: 3 cases MDR and IVDR (article 16(1))

Distributor’s own name or registered trademark on the device

Intended purpose of the device is affected

Compliance with applicable requirements is affected

If the device already on the market is assembled or

adapted (by a person other than the manufacturer) for an

individual patient, withoutchanging its intended purpose

General exception


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CASE 1 MDR and IVDR (article 16(1))

• The distributor makes a device available on the market with its own name or registered trademark

Own name or registered trademark

If the manufacturer is identified as such on the label and is responsible for meeting the

requirements placed on manufacturers

Exception to case 1


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• The distributor changes the intended purpose of a device placed on the market or put into service

Intended purpose affected


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• The distributor modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected

Compliance with applicable

requirements affected

• Provision and translation of (i) manufacturer’s label and instructions for use and (ii) any information necessary to market the device in MS

• Repackaging necessary to market the device in MS (condition of the device cannot be affected)

Exceptions to case 3

• A distributor that carries out these activities is not considered as legal manufacturer

• However, a specific legal regime applies


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• Provision and translation of(i) manufacturer’s label and instructions for use and (ii) any information necessary to market the device in MS

• Repackaging necessary to market the device in MS (condition of the device cannot be affected)

Exceptions to case 3

1. Prior notification

• 28 days prior to making the relabelled or repackaged device available on the market: distributors to (i) Inform manufacturer and competent authority (+ provide mock-ups) and (ii) Submit NB certificate attesting that QM system is compliant

2. Quality management

• Distributor to have a QM system in place to allow (i) Accurate and up-to-date translation of information, (ii) Preservation of the original condition of the device and quality of re-packaging, and (iii) Answering to safety issues and taking corrective actions

3. Information requirements

• Distributor to indicate on the device (or packaging or accompanying document): (i) Activity carried out, (ii) Name, (iii) Registered trade name or trade mark, (iv) Registered place of business and (v) Contact address

C MDR and IVDR (article 16(3-4))


3. Autonomous obligations of distributors under the MDR and IVDR


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Rationale MDR (recital 27), IVDR (recital 25)


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Two types of obligations

Pre-marketing Post-

marketing

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1. Pre-marketing


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1. Pre-marketing MDR and IVDR (article 14(1))

Before the distributor makes a device available on the market

General obligation to “act with due care in relation to the requirements applicable”, “in the context of their activities”

“Act with due care” = ? “Due care refers to the effort made by an ordinarily prudent or reasonable party

to avoid harm to another, taking the circumstances into account. It refers to the level of judgment, care, prudence, determination, and activity that a person would reasonably be expected to do under particular circumstances”European Commission ‘Blue Guide’ on the implementation of EU products rules 2016

“Their activities”= ?

“For the purpose of this Regulation, the activities of distributors should be deemed to include acquisition, holding and supplying of devices”MDR (recital 28), IVDR (recital 26)


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1. Pre-marketing MDR and IVDR (article 14(2))


What if a distributor believes that a device is not in conformity with the requirements of the MDR / IVDR?

Making available = forbidden “until it has been brought into conformity” ( By whom?)

Inform manufacturer / authorised rep. / importer

Inform national authorities if (i) serious risk or (ii) falsified device

“where a distributor considersor has reasons to believe”

“competent authority of the Member State in which it is established”


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1. Pre-marketing MDR and IVDR (article 14(2), 10(10/11))


Verification by the distributor Manufacturer

CE marking and EU declaration of conformity(What if the device is misclassified by the manufacturer?)

Device accompanied by the label and instructions for use ( And in the right language? – in Belgium)

UDI assigned, where applicable

To meet these requirements, distributors may apply a sampling method that is representative of the devices supplied by the distributor


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1. Pre-marketing MDR and IVDR (article 14(2), 13(3))


Verification by the distributor Importer

For imported devices, check that the importer has indicated the following:

Name

Registered trade name or trade mark

Registered place of business and contact address

Any additional label does not obscure the manufacturer’s labelling information

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2. Post-marketing


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2. Post-marketing

(1) (2) (3)

Manufacturer Importer Distributor

First placing of the device on the market

Putting the device into service

First placing of the device on the market

Making the device available on the market

Three situations (which can be combined)


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2. Post-marketing MDR (article 10(12)), IVDR (article 10(11))

(1) Manufacturer placed the device/put it into service on the market

Manufacturer due to comply with its own general obligations

If the manufacturer believes that the device is placed on the market/put into service in breach of the MDR / IVDR

Product withdrawal or product recall by the manufacturer

Distributor must be informed of the device in question ( Distributors informed automatically)

+ (where applicable) recording and reporting of incidents by the manufacturer via EUDAMED


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2. Post-marketing MDR and IVDR (article 13(6-7))

(2) Importer placed the device on the market

Importer due to comply with its own general obligations

If the device is placed on the market by the importer in breach of the MDR / IVDR

Information/cooperation with manufacturer, authorised rep. and competent authorities (corrective action, withdrawal or recall)

Keep a register of complaints, non-conforming devices, recalls and withdrawals

Distributors must be provided with any information requested by them, in order to allow them to investigate complaints ( Distributors provided with information upon request)


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2. Post-marketing MDR and IVDR (article 14(4))

(3) Distributor makes the device available on the market

What if a distributor believes that a device, which it has made available, is not in conformity with the requirements of the MDR / IVDR?

Immediately inform manufacturer / authorised rep. / importer

Cooperation with manufacturer / authorised rep. / importer / competent authorities ( corrective action, withdrawal or recall)

Inform national authorities if (i) serious risk or (ii) falsified device and provide details

“where a distributor considersor has reasons to believe”

“competent authority of the Member State in which the device is available”


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2. Post-marketing MDR and IVDR (article 14(5))

(3) Distributor makes the device available on the market

What if a distributor receives complaints or reports from HCPs, patients or users about suspected incidents related to a device, which it has made available?

Immediately forward to manufacturer / authorised rep. / importer

Keep a register (= monitoring) of complaints, non-conforming devices, recalls and withdrawals

Keep manufacturer / authorised rep. / importer / competent authorities informed of the monitoring and provide any information upon request


4. Advertising (in vitro diagnostic) medical devices under the MDR / IVDR


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4. Advertising medical devices under the MDR/IVDR

What is the impact of the MDR / IVDR on advertising?

Regulating EU advertising practices was not the purpose of the recast ( Provisions not comparable with Directive 2001/83/EC on the Community Code relating to medicinal products for human use)

However, new provisions addressing “claims”

To be read in conjunction with the MedTech Europe Code of Business Practice, binding upon members


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“Claims” – Scope MDR and IVDR (article (7))

When advertising medical devices

When putting the device into service

When making the device available

In the instructions for use

In the labelling

Using text, names, trademarks, pictures and figurative or other signs


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“Claims” – What is prohibited? MDR and IVDR (article (7))

1. Ascribing functions and properties, which the device does not have

2. Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have

3. Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose

4. Suggesting uses for the device other than those stated to form part of the intended purpose

Resulting in the user or patient being misled with regard to the device’s intended purpose, safety and performance


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“Claims” – Consequence of a breach?

Mainly at national level

National health authorities (FAMHP in Belgium) responsible for enforcement

Competitors may go in front of a national court (breach of the EU MDR / IVDR)

+ Role of NB MDR and IVDR (Annex VII, 4.10)

NB may ask manufacturers when conformity are detected to correct them, to undertake corrective and/or preventive actions

NB mays also impose specific restrictions on the relevant certificate, or suspend or withdraw it ( direct impact on distributor)




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Non-conform device placed on the market by the distributor

Reminder… MDR and IVDR (article 14(4))

If a distributor considers or has reasons to believe that it has placed a non-conform device on the market

Immediately inform manufacturer / authorised rep. / importer

Cooperation with manufacturer / authorised rep. / importer / competent authorities ( corrective action, withdrawal or recall)

+ Inform competent authorities if (i) serious risk or (ii) falsified device and provide details on the non-compliance and corrective action taken


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Demonstrate the conformity of devices MDR and IVDR (article 14(6))

Obligation for distributors to provide competent authorities (upon request) with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device

Distributors are considered to have fulfilled this obligation if the manufacturer / authorised rep. provides the information to the authorities


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Eliminate risks and provide free samples MDR and IVDR (article 14(6))

Two ancillary obligations

Obligation to cooperate with competent authorities (upon request) to eliminate risks posed by devices made available by the distributor

Obligation to provide competent authorities (upon request) with free samples of the device (or grant access to the device)


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Registration of distributors MDR (article 30) and IVDR (article 27)

As a general rule, “economic operators” are required to identify themselves on the EUDAMED platform in accordance with Annex VI

However, both this general rule (article 30 MDR / 30 IVDR) and Annex VI expressly mentions the manufacturer / authorised rep. / importer, but not the distributor – lack of clarity

With regard to distributors, the MDR / IVDR allow MS to maintain or introduce national provisions on registration of distributors of devices made available on their territory

In Belgium: registration on SADN / ABGD platform required by Royal Decree


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Identification of the supply chain MDR (article 25(2)) and IVDR (article 22(2))

Economic operators must be able to identify the following to the competent authority:

Any economic operator to whom they have directly supplied a device

Any economic operator who has directly supplied them with a device

Any HCO or HCP to which they have directly supplied a device

For 10 years after the last device covered by the EU declaration of conformity has been placed on the market (or 15 years in case of implantable devices)




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General principles of liability (overview)

A. Contractualliability

B. Extra-contractualliability

C. Productliability

1. General principles2. Specific protection for

consumers

1. Who can be a ‘producer’?

2. Defective product3. Damage4. Causal link5. Who can be a

‘claimant’ ?6. Time limit

1. Civil code (art. 1382-1384)

2. Fault3. Damage4. Causal

link


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6. Distributors and liability – (1) Contractual liability

(1) Liability based on contract [breach of the contract]

Supply agreements:

Manufacturer Importer Distributor End-user

Third party

Claim Claim Liable towards

Distribution agreements:

First viewpoint: contractual liability


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Examples of contractual relationships (sales):

The legal action for hidden defects towards the producer (original seller) follows the sales alongside the supply chain (Mons, 18 April 2006, art. 1615 Civil Code)

Producer – Distributor

Distributor – Hospital

Distributor – Pharmacist

Retailer – Patient


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When the seller is a professional, the damage to be compensated includes:

Damage to the defect product itself and to the loss of use of the product

“External” damages (even above the value of the product)

Including damage to other goods of the purchaser

And more generally any damage resulting from the use of the defective product (consequential damages including loss of profit, time spent, prejudice to the reputation of the purchaser, etc.)


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Time limitation

General liability rules : 10 years

For hidden defects : the purchaser must act “on short notice” (art. 1648 Civil Code)


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Consumers

Specific rules apply when the purchaser is a consumer (patient)

Belgian Civil Code (art.1649bis seq.)

For such rules, a time limitation of two years applies

Specific protection for consumers


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6. Distributors and liability – (2) Product liability

Second viewpoint: product liability MDR (article 10(16)) and IVDR (article 10(15))

(2) Based on tort [several grounds possible – focus on product liability]

“Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law”

Provision inserted under article 10 on obligation of manufacturers Relevance for distributors?


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What will be changing with the MDR / IVDR ?

From product liability standpoint: MDR / IVDR only refer to existing regulations: “applicable Union and national law”

Union law National law

Directive 85/374/EEC on liability for defective products

Converted into national laws

Strict liability (without fault)

Producers’ liability under tort law

Belgium: Act of 25 February 1991 on defective products (“PLA”)


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“The producer shall be liable for damage caused by a defect in his product.” (article 1 of the Product Liability Act of 25 February 1991 (“PLA”)= Belgian implementation of EU Directive 85/374/EEC)

Several conditions :

1. Who can be considered as a "producer"?

2. Defective product

3. Damage

4. Causal link

5. Who can be considered as a “claimant” ?

6. Time limit

Burden of proof on the claimant


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From product liability standpoint, the following can be considered as a “producer” in the sense of Directive 85/374 and PLA

Manufacturer [Original Equipment Manufacturer (OEM), Assembler]

Authorised rep. [ Liable on the same basis as the manufacturer]

Importer [Importing a product into the Community for distribution ]

Supplier [Producer of raw material, manufacturer of a component part]

Quasi-producer [Own Brand Labeller, anyone presenting itself as the producer]


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See section 2 above – when an importer/distributor must comply with obligations as a manufacturer

Under the PLA – Who can be considered as “producer”?

“The manufacturer of a finished product, the manufacturer of a component part of a finished product or the producer of raw materials“

“Any person who present itself as manufacturer or producer by placing on the product its name, trade mark or other distinctive sign“

“Any person who, as part of its economic activity, imports into the European Community a product in order to sell or transfer its use to a third party“


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Who can be considered as “producer”?

Alternatively (where the producer of the product cannot be identified), each “supplier” of the product (unless he informs the injured person, within a reasonable time, of the identity of the producer or of the person who supplied him with the product)

But not the user having acquired the product (hospital, lab or doctor)

See ECJ, C-495/10, CHU Besançon / Dutrueux and CPAM (Judgment, 21 December 2011)


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“By virtue of Article 3(1), the producer will in most cases be the manufacturer.

The Court has held that attempts under national law to extend the liability to suppliers of a product will, prima facie, be in breach of the directive’s aim of achieving complete harmonisation in respect of the matters regulated by it.

At the same time, however, it has held that the scope of the directive, and hence of the complete harmonisation which it seeks to provide, is limited to the area of no-fault liability.

It follows that Directive 85/374 is to be interpreted as not precluding the application of other systems of contractual or non-contractual liability based on other grounds, such as fault.”

CJEU, C-219/15 (Advocate General Sharpston), opinion published on 15 September 2016, par. 32


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Without prejudice to legal actions between producers:

Producers are jointly liable vis-à-vis the victim (art. 9 PLA)

Liège, 18 October 2004

Liège, 7 November 2005

Vis-à-vis the victim, a producer is liable if the damage is caused both by a defect in the product and by the intervention of a third party (but not when the damage is cause by the victim himself/herself) (Article 10 PLA)


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Strict liability

Under the PLA, it is not necessary, to establish the existence of a fault

It is necessary and sufficient to establish the existence of a defect in the product, which does not necessarily requires the proof of an absolute scientific certainty, but demands a sufficient degree of certainty as to establish that the damage cannot have any other cause

Civ. Brussels, 10 February 2005


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Link with devices Regulations MDR (recital 31), IVDR (recital 30)


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6. Distributors and liability – (3) Non-compliance


In addition to product liability, non-compliance with the new obligations can trigger liability for any economic operators (including distributors)

Both contractually and based on tort law

Technical Documentation is increasingly important in product liability cases

Ensuring compliance of any information and documentation is key to demonstrate conformity


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6. Distributors and liability – (4) New obligations

What will be changing with the MDR / IVDR ? MDR (article 10(16)), IVDR (article 10(15))

New obligation to financial coverage for manufacturers

Proportionate to the risk class, type of the device

Proportionate to the size of the enterprise

Product liability insurance, possibly by an exemption or warranty obligation issued by a credit institute

No corresponding coverage obligation for distributors, importers or authorised rep.

Theoretically, more protective measures may be taken by MS

Relevance?Predictability?

In practice, option limited by Directive 85/374


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New entitlement to information

Facilitate the provision of all the information and documentation necessary to

demonstrate the conformity of the device

Potentially injured patients / users / successors in title

Health insurance company

Affected third parties

Competent authority

Uponrequest

If the competent authority considers or has reason to believe that a device has

caused damage

Broad


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New entitlement to information

Not an absolute right – Limitations:

Protection of IP

Data protection, except if public interest in disclosure

Action in front of a judge

… In which case the competent authority does not have to comply with this obligation


The EU Medical Devices Regulations – Impact on distributors

Conclusions

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Step 1 May 2017

Distributors – priorities

Publication (05 May 2017)

Regulations

Implementing acts /delegated acts

EIF (25 May 2017)

From alegal perspective

(determines starting point of the transitional period)

From a practical perspective

(implementing acts, EUDAMED, NBs, MDCG, expert panel, ref.

laboratories…)

Adoption of MDR and IVDR


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Step 2 2017 – 2018


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Compliancecheck /

assessment

Regulatory obligations

• Do I comply with all legal requirements imposed on distributors?

Claims

• Do I comply with the “claims” requirements of the Regulations?

Authorities

• Am I prepared to answer the requests from competent authorities?

Liability

• Have I done everything to avoid liability risks and am I covered to face such potential risks?



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Step 3 2017 – 2019


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Take action

Consider reviewing current distribution agreements and upcoming contracts, both upstream (providers, manufacturers, importers) and downstream (third-party distributor, end-user)

Prepare internal procedures for compliance with the MDR / IVDR vis-à-vis competent authorities and the other economic operators

Envisage covering liability risks (e.g. insurance)

Monitor enforcement at national level



Thank you for your attentionQuestions ?

Annabelle BruyndonckxCounselSimmons & Simmons LLPT +32 2 542 09 60E [email protected]

Olivier MignoletPartnerBrusselsT +32 2 542 09 60E olivier.mignolet

@simmons-simmons.com

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The EU Medical Devices Regulations – Impact on … · Council directive 93/42/EEC of 14 June 1993...

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