Module 17 2024

Module 17 : Regulatory Strategy in the Post Market Phase Date: 4th - 6th Dec em ber 2024 Module: 17 of the TOPRA MSc Regulatory Affairs Module Leader: Jane Arnold-Round

©The Organisation for Professionals in Regulatory Affairs 2024 Presentations are supplied to delegates for their personal reference and are the copyright of the speaker and The Organisation for Professionals in Regulatory Affairs. The presentations must not be copied, stored in a retrieval system or transmitted in any form without prior permission from TOPRA. Agreement must be reached with TOPRA before any part of this material is reproduced, abstracted, stored in a retrieval system or transmitted in any form by any means – that is, electronic, mechanical, photocopying, recording or otherwise.

Module 17: Regulatory Strategy in the Post Market Phase 4 th – 6 th December 2024

LOCATION: TOPRA OFFICE, 6 TH FLOOR, 3 HARBOUR EXCHANGE, LONDON, E14 9GE AND ONLINE

Module Leader(s) : Jane Arnold- Round

Date: 4 th – 6 th December 2024

Wednesday 4 th December 2024

Time

Activity

Speaker

Jane Arnold-Round

13.30 -14.30

Welcome & Introduction to the Module Lecture 1: The Role of the RA Professional and Good Regulatory Practice

NAMSA

Elizabeth-Anne Larsen

14.30 – 15.30 Lecture 2: Product Liability Law

CMC Law

15.30 – 16.00

Refreshment break

Stuart Helmer &

16.00 – 17.00 Lecture 3: Advertising and Promotional Issues

Bonnie Clemence

CMC Law

Module 17: Regulatory Strategy in the Post Market Phase 4 th – 6 th December 2024

Date : Thursday 5th December 2024

Time

Activity

Speaker

Kevin Butcher

09.00 – 11.00

Lecture 4: The UK Regulatory System

NAMSA

11.00 – 11.30

Refreshment Break

Geoff Fatzinger

11.30 – 12.30

Lecture 5: Interactions with Regulatory Authorities

Spectrum Global Consulting

12.30 – 13.30

Lunch

Kevin Butcher

13.30 – 14.30

Lecture 6: Unannounced Audits

NAMSA

Jonathan Craven

14.30 – 15.30

Lecture 7: Data Privacy & Protection Freedom of Information and Transparency

Irhythmtech

15.30 – 15.45

Refreshment Break

Jane Arnold-Round

15.45 – 17.45

Case Study

NAMSA

Module 17: Regulatory Strategy in the Post Market Phase 4 th – 6 th December 2024

Date: Friday 6 th December 2024

Sinan Utku

09.00 – 10.00 Lecture 8: Intellectual Property

Covington & Burling LLP

10.00 – 10.15

Refreshment Break

Geoff Fatzinger Spectrum Global Consulting

Lecture 9: Environmental Legislation

10.15 – 11.15

Geoff Fatzinger Spectrum Global Consulting

11.15 – 12.15 Lecture 10: Reimbursement and HTA

12.15 – 13.15

LUNCH

Lecture 11: When do the Obligations of Manufacturers Apply to You?

Howard Dobbs

13.15 – 14.15

Howard Dobbs Associates

14.15 – 14.45

Refreshment Break

Phil Brown

14.45 - 15.45

Lecture 12: Trade Associations

ABHI

27/11/2024

Lecture 1: The Role of the RA Professional and Good Regulatory Practice

Jane Arnold-Round, Senior Principal Regulatory Consultant

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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The Role of the RA Professional and Good Regulatory Practice

Agenda

Regulatory roles

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• Person Responsible for Regulatory Compliance (PRRC)

• Specific regulatory roles in the UK

• Good Regulatory Practice: GRP

Case study (tomorrow)

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The Role of the RA Professional

Q. What do we do?

…..Write submissions and Get approvals

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The Role of the RA Professional

Writing submissions Obtaining approvals

Additional Roles: QA

Identifying requirements Interpreting requirements Determining regulatory strategy and timelines Reviewing documents e.g. test reports Writing key documents e.g. CERs Participating in/ leading key processes: - Risk management - Vigilance Auditing

Technical

AR

Clinical

PRRC

Commercial

Representing the company: Conferences Manufacturer associations Professional associations Other activities: Standards work Regulatory due diligence

Liaising with regulatory bodies Addressing non conformities Maintaining CE certification Providing Training

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The Role of the RA Professional

Person Responsible for Regulatory Compliance in the MDR(PRRC)

• Responsible for regulatory compliance

• Responsible for ensuring that:

• Device conformity checked

• Technical documentation kept up to date

• Declaration of Conformity drawn up/kept up to date

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The Role of the RA Professional

Person Responsible for Regulatory Compliance in the MDR(PRRC)

• Responsible for ensuring that:

• PMS obligations are complied with

• Vigilance Reporting obligations are fulfilled

• Statement of compliance (for clinical investigational devices)

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The Role of the RA Professional

Qualifications and experience:

“…the requisite expertise in the field of medical devices… demonstrated by…”

• Degree (or equivalent) in a relevant area

+ 1 year RA/QA experience in medical devices

OR

• 4 years RA/QA experience in medical devices

• 2 years experience for custom made devices

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The Role of the RA Professional

Practical Issues:

• Available within the organisation

(Exemption for micro and small enterprises)

Duties can be shared

•

• Applies to manufacturers and Authorised Reps.

Registration on EUDAMED

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• Guidance available: MDCG 2019-7 Rev 1

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The Role of the RA Professional

Specific Roles in the UK

• The UK Responsible Person

• Qualified Person (future)

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The Role of the RA Professional

The UK Responsible Person

” a person established in any part of the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer's obligations under these regulations”

• Only required for manufacturers located outside the UK

• Manufacturer must appoint a UKRP in writing

• Appears on labelling of UKCA marked devices

• Responsible for registering devices with the MHRA

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The Role of the RA Professional

The UK Responsible Person

Responsibilities include:

•

• Declaration of Conformity, technical file, conformity assessment

• Provide device samples to MHRA on request

• Cooperate with MHRA on CAPAs to eliminate/mitigate risks

• Immediately inform manufacturer about complaints/suspected incidents

• Terminate contract in case of non compliance by the manufacture

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The Role of the RA Professional

Proposed Future Requirement – A qualified Person

• Responsibilities would include supporting the manufacturers UK compliance

• Minimum qualifications/experience

• Within the manufacturers organisation (except SMEs)

• UKRP to have a qualified person

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The Role of the RA Professional

Equivalent Regulatory Roles EU and UK

Europe

UK

PRRC

Qualified Person

EU Authorised Representative

UK Responsible Person

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The Role of the RA Professional

The Regulatory Role

Diverse

Communication is key

Impact throughout the device

life cycle

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The Role of the RA Professional and Good Regulatory Practice

Blue sky /concept stage:

• Get involved/Ask questions:

• What does it do? how does it do it? what’s it made of? who is it for? • Which markets are of interest? • Communication • regulatory strategy • risk • Planning • Timelines (internal and external) • Costs e.g. Notified Body fees

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The Role of the RA Professional and Good Regulatory Practice

Design and development phase:

• Stay involved /keep asking questions • Changes to the device….or the claims • Have timelines slipped? • Communication • Flag any gaps • Have regulatory requirements changed?

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The Role of the RA Professional and Good Regulatory Practice

Submission phase:

• Peer review

• Identify remaining gaps and weaknesses

• Check availability of key team members

• What was approved?

• Archive submission information

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The Role of the RA Professional and Good Regulatory Practice

Post approval phase:

• Ensure specific approval commitments are met

• Stay involved /keep asking questions

• Plan in time for renewals and for ongoing processes

• Keep up to date with requirements

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The Role of the RA Professional and Good Regulatory Practice

Questions?

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TOPRA MSc Module 17

Medical Device Product Liability

4 December 2024

Elizabeth-Anne Larsen, Senior Associate – Solicitor Advocate, CMS Cameron McKenna Nabarro Olswang LLP E: elizabeth-anne.larsen@cms-cmno.com T: +44(0)207 524 6115

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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Overview

• Product safety vs. product liability • Product Liability and some pipeline developments – Contract – Negligence – ‘Strict Liability’ under the new Product Liability Directive 2024/2853/EU (New EU PLD) – Recent legal decisions on ‘defect’ • Interaction between the EU MDR and the EU product liability framework

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Product Safety – v- Product liability

Legal duties on those who market products enforced via injured persons, (e.g. patients) bringing compensation claims before the civil law courts

Legal duties on those who market products enforced via public law regulatory authorities, (e.g. MHRA) – often via criminal law

Claims by persons injured by a product are based on: • Breach of a contract for sale of goods • Negligent design, manufacture or marketing • Damage caused by a defect in a product (revised EU PLD / Consumer Protection Act 1987) • Medicines & Medical Devices Act 2021 • Draft AI Liability Directive

Legislation setting out acceptable health & safety levels for products : •“New Approach” legislation (e.g. EU MDR) •“New Legislative Framework” (NLF) 2008 – 2019, e.g. RAMS (Regs

765/2008/EC & 2019/2010/EU) • EU AI Act 2024

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Product liability

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What are the legal bases for product liability claims?

Legal basis

What is the claim for? Look first at the supply chain

1 Contract

Damages claim for breach of contract terms re Quality (Safety) and Fitness for Purpose

2 Negligence

Damages claim for breach of duty of care causing reasonably foreseeable damage

3 Strict liability for “EOs” (new Product Liability Dir. 2024/2853 ((new) EU PLD )/ “producers” (Consumer Protection Act 1987) 4 MDR/IVDR potential AR liability – Art.11(5)

Damages claim for losses caused by defective products

Damages claim for losses caused by defective products IF ex-EEA Manufacturer has also breached Art.10 MDR obligations

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In the EU/UK pipelines…

EU Collective Redress Directive 2020/1828/EU (entered into force 24 Dec 2020)

• Domestic and cross-border injunction and redress representative actions • E.g. Product Liability Directive, infringements of Chapter II MDR/IVDR which harm collective interests of consumers & future EU Directive on AI Liability •Expect increased risk of ‘class action’ litigation in MSs with currently low levels of collective redress litigation • National transposition by 25 Dec 2022; date of application: 25 June 2023 • By 26 June 2028, the EC will evaluate the Directive/present a report of its main findings. UK: breach of statutory duty (civil) claim in the Medicines and Medical Devices Act 2021 for “ any person who may be affected by a breach” of UK Medical Devices Regulations (MMDA 2021, Ch. 3, s.38)

UK: AI Regulation White Paper (March 2023) and MHRA Policy Paper on Impact of AI on the regulation of medical products (April 2024)

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In the EU pipeline – medical device software and AI …

EC report on safety and liability implications of AI, IoT and robotics (Feb 2020) • EU AI Act (1 Aug 2024) • Draft AI Liability Directive (28 Sep 2022) • New EU Product Liability Directive (2024/2853) (enter into force 9 Dec 2024, repealing 85/374/EEC) • Machinery Products Regulation ((EU) 2023/1230) (19 July 2023) • EU General Product Safety Regulation ((EU) 2023/988) (12 June 2023)

AI risk characteristics

• Complexity • Supply chain • Components • Connectivity (IoT) • Vulnerability to 3P cyber-attack and openness to post market modification • Autonomy and opacity Potential deficits identified in current EU safety regimes for AI

Gaps in actionable losses

Proposals for legislative adjustments

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1. Breach of a contract for sale or supply of goods

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UK Strict Liability in Contract (B2B)

Statutory implied quality warranties for B2B sellers under Sale of Goods Act 1979 (SGA), if applicable (e.g. framework / call-down supply agreements following public procurement) • Satisfactory quality (s.14(2)) • Reasonable fitness for purpose (unless no reliance) (s.14(3)) • Correspondence with description (s.13) Statutory implied quality warranties for B2B suppliers under Supply of Goods and Services Act 1982 (SGSA) • Same as SGA regarding transfer of property in goods, if applicable • Services will be carried out with reasonable care and skill (s.13) Implied statutory quality warranties can be excluded B2B if exclusion satisfies UCTA “reasonableness test” (ss. 6(3) & 7(3))

NB: Consumer Rights Act 2015 contains equivalent implied warranties for B2C sales and supplies

Misrepresentation Act 1967

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2. Negligent design, manufacturing, marketing [EU: and/or non-compliance with AI system obligations]

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Fault based liability (negligence) (1)

Whether injury is caused by the conduct of a person?

• Acts / omissions (negligence / carelessness) • Only concerned with inadequate quality of a product as this results from faulty behaviour (e.g. carelessness) All producers owe a legal duty of care to end users (EU have extended this for high- risk AI systems to “deployers” (see AI Act for definitions))

All other suppliers owe legal duties to take reasonable care within the sphere of their own responsibility

• Potentially includes Notified Body (Case C-219/15 Schmitt – v- TUV Rheinland) and in EU will likely include all suppliers in SaMD / AIaMD supply chain (draft EU AI Liability Directive) Quality of the conduct must fall below a reasonable standard (reasonable care and skill) morally characterised as implying fault

• Choice and control of the product development process • Verification and validation during development process • Appropriateness of manufacturing processes and materials • Warnings and instructions to enable safe use • Adequacy of post-market surveillance / corrective actions •EU MDR/IVDR: additional “economic operator” responsibilities •EU AI Act “provider”/”deployer” responsibilities

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Fault based liability (negligence) (2)

Any injured purchaser / user / bystander has a direct right of action against any person in the supply chain (particularly the manufacturer) if not too remote • Designer, importer, seller • AR, distributor, systems & procedure pack Mfrs and Sterilisers now more likely targets? • EU extended this for high- risk AI systems to “providers” and “deployers” (see AI Act for definitions) Claimant must usually prove all elements of the claim: • Burden of proof: usually on a balance of probabilities (51:49) • Sometimes: burden of proof reversed, e.g. if product fails unexpectedly following normal use • Draft EU AI Liability Directive alleviates claimants’ burden of proof: • Where D fails to disclose evidence pursuant to court order • Presumes causation if D breaches specified EU AI Act obligations directly intended to protect against damage and reasonably likely D’s breach influenced AIaMD output (or lack of output) and that that caused the damage • Duty Fault Causation injury / loss

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Practical difficulties (UK negligence):

Is there a legal duty of care?

Limits on recoverable losses • Death, personal injuries (and consequential losses) • [EU draft AI Liability Directive aims to facilitate recovery of any type of damage by any type of victim] • Damage to property • Consequential losses • UK : No recovery for pure economic losses (unless negligent misstatement) Causation

Foreseeability of loss

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3. ‘Strict liability’ under EU Product Liability Directive (PLD): (2024/2853) and Consumer Protection Act 1987

Damage caused by a defect in a product

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Recoverable Losses

Any injured person can sue

No recovery for damage to commercial property, but no min for prop damage

No recovery for pure economic loss (but see 2015 CJEU cases & revised EU PLD)

Claimant must have suffered damage (Art.9) • Death / personal injuries (incl cost of treatment etc) • Damage to / destruction of physical property (excluding the defective product itself) provided the item of property: • Is of a type ordinarily intended for private use or consumption, and

• Was used by the injured person mainly for his own private use or consumption • Revised EU PLD: compensates loss, or corruption, of non-professional use data

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Defences to strict liability claims

In practice, companies aim to take defective products out of circulation to mitigate the risk. Most contested claims involve denial of any ‘defect’, reliance on warnings or disputing the causal effect of any defect that existed.

True legal defences

Exclusion Clauses

Defect attributable to compliance with mandatory law

Liability to an injured person cannot be limited or excluded by contact term or notices

Defendant not a supplier

Defect not present when put into circulation

State of scientific and technical knowledge not such that producers might be expected to discover defect

Component product incorporated in a subsequent defective product

Ten-year, long-stop limitation period (new EU PLD extends to 25 years for latent injuries)

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Who is “strictly liable” for a defective product in UK?

1 st Importer into GB*

“Own Brander”

“Producer”

Manufacturer

Each “Supplier” can be liable as “Producer” if it fails to identify previous supplier

User/Patient

Test for defectiveness: “ There is a defect in a product…if the safety of the product is not such as persons generally are entitled to expect ”. • *Changed geographic scope for UK from 1 Jan 2021 (Consumer Protection Act 1987), used to be first importer into the EEA

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New EU PLD

ECONOMIC OPERATORS LIABLE FOR DEFECTIVE PRODUCTS

Increase in potential secondary Ds:

Increase in potential primary Ds:

Manufacturer of a product

Component manufacturer

EU distributor

First importer who places the product onto the Union market from third country

Online platform

EU Authorised Representative

FSP (Fulfilment Service Provider)

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Test for defectiveness?

UK: “… there is a defect in a product…if the safety of the product is not such as persons generally are entitled to expect ”. “ All the circumstances shall be taken into account, including… ” (a) the manner in which, and purposes for which the product has been marketed, its get-up, instructions or warnings; (b) what might reasonably be expected to be done with the product; and (c) the time when the product was supplied by the producer Section 3, Consumer Protection Act 1987 New EU PLD adds circumstances to consider: • Date of ‘pom’ or end of manufacturer’s control • Relevant product safety requirements, incl safety-related cybersecurity • Any recall/other relevant intervention by a CA or an EO related to product safety • The needs of the group of users for whom the product is intended

Regulatory compliance may not be seen as a benchmark for safety

There is no explicit risk/benefit criteria in the defect test

CJEU litigation advocates higher legitimate expectations for human implantables

Pressure on courts to infer the existence of defects simply from the alleged injuries

Revised EU PLD presumes defectiveness if:

• D fails to disclose evidence following court order • Product not compliant with mandatory PS requirements intended to protect against the risk of the damage allegedly suffered, or • Damage caused by obvious product malfunction during reasonably foreseeable use/under ordinary circumstances

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NEW EU PLD: BOP AND REBUTTABLE PRESUMPTIONS

Presumption of CAUSATION (causal link between the defect and the alleged damage):

Presumption of DEFECT, CAUSAL LINK, or BOTH where:

Presumption of DEFECT:

• D fails to disclose relevant evidence ; or • C “demonstrates” product non-compliance with

•

Despite the disclosure, and in consideration of “all relevant circumstances”, the C faces “excessive difficulties”— due to technical or scientific complexity — to prove the defectiveness, causal link, or both; and

• C “demonstrates” (1) the product is defective, and

mandatory PS reqs intended to protect against the risk of

the damage allegedly suffered by the C; or

(2) the damage caused is of a kind typically consistent with the defect in question

• C “demonstrates” it is likely that the Product is defective, or that a causal link between defectiveness/damage/both exists

• C “demonstrates” alleged damage was caused by an obvious product malfunction during reasonably

foreseeable use/under ordinary circumstances

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“Defect categories”

Manufacturing

Design

Instructions / Warnings

Marketing

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Some Defect Cases

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Meaning of ‘defect’ (implantable medical devices)

Combined CJEU judgments: German Health Funds litigation against Boston Scientific (Cases C 503/13 & C-504/13 of 5 March 2015) • Individual AIMD is defective if belonging to same group, or forming part of same production, as products found to have a potential defect • Pacemakers subject to advisory action for premature battery depletion • Particularly high requirements for meddevs because of their function and particularly vulnerable patient user group

Defective if product risks have an abnormal, unreasonable character exceeding normal risks inherent in use • German court considered the expectation that a failure rate of close to zero would be reasonable in view of life-threatening risks presented by the product and in spite of specialist medical opinion that a 100% safe pacemaker was impossible • Advocate General: advocated a special “patient safety” category for defectiveness test

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Design Defect? Wilkes v DePuy International Limited MoM Hip Implant Litigation – 1st instance England (2016)

Total hip replacement femoral neck fracture – design defect alleged because persons generally would not have expected the stem to suffer from early fracture Defendant argued fatigue fracture = rare but recognised risk & noted in IFU – amongst most frequently encountered AEs – stems tested acc relevant British Standard

•

Not defective:

• Product met all relevant mandatory standards and regulatory requirements • Fatigue failure rate complied with relevant BSs • Fact that neck thread could have been avoided fails to take account of possible design disadvantages of such changes – not appropriate to design out entirely the single risk without regard to other design features • Unambiguous and clear IFU warnings re femoral stem fatigue • Small risk of fracture and relatively

•

limited consequences (i.e. revision operation)

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Judgment: Wilkes v DePuy International Limited “Safety” is inherently and necessarily a relative concept

“Fair apportionment of risk” – legislation not driven solely by consumer interests

Focus should be on ascertaining whether there is a defect and if so, what that might be

Defectiveness test is not assessed by reference to actual or notional persons’ expectations Claimant need not prove cause of lack of safety, or why product failed ( Ide v ATB Sales Ltd [2008] EWCA Civ 424) but must prove a causal link between defect and damage No restriction on relevant circumstances which should be taken into account in connection with the defectiveness test Focus must be on the product itself when determining ‘safety’ – no undue concentration on acts / omissions of designer/producer. • Question whether a risk is ‘avoidable’ unlikely to be fruitful for implantables but may be relevant to level of safety public generally entitled to expect

• Possible disadvantages of different design solutions must be considered Compliance with specification and standards both relevant circumstances

Knowledge of the medical profession, IFU warnings are relevant circumstances

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Gee & Others v DePuy International Limited [2018] EWHC 1208 MoM Hip Implant Group Litigation – 1st instance England (2018)

Judgment: • PLD balances interests of consumers and producers - system of non-fault liability for products that fail to meet the standard of safety •‘Defect’ = failure to meet an objective standard of safety that Court must evaluate - Court must be flexible when determining appropriate standard of safety • All circumstances with a bearing on the safety of the product should be taken into account • Only an abnormal propensity to cause ARMD, otherwise expressed as a materially greater risk of the product failing within 10 years, would amount to a defect • Level of safety to be measured by reference to what was known (re safety) at the time of placing on the market. • Subsequent performance of later products, incl within the Pinnacle System, could not inform entitled expectations as to the level of safety •“Worst - in class” product not necessarily defective

Group action preliminary issue to determine if Pinnacle System hip was defective or not

Alleged Adverse Reaction to Metal Debris (ARMD) caused by the debris generated by prosthesis, which necessitated revision surgery

Alleged defect:

• The product’s propensity to shed metal debris and consequently to require revision surgery; or • Materially increased risk of the prosthesis failing within 10 years, when compared to an appropriate comparator, also described as an abnormal risk of damage

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John Hastings v Finsbury Orthopaedics Ltd, Stryker UK Ltd [2022] UKSC 19

MoM prosthetic hip replacement

•

Not defective:

• Endorsement of recent case law - Wilkes v DePuy and Colin Gee & Others v DePuy International Ltd • Objective test for defectiveness • There can be no entitlement to an absolute level of safety • Generalised expressions of professional concern were not determinative of a defect for the specific product in issue • Field safety notices and medical device alerts were considered in light of subsequent up-to-date evidence • A product recall did not automatically amount to evidence of a defect • Product met the regulatory standards and requirements at the time of manufacture. • Insufficient statistical data because it did not conclusively show a higher failure rate than expected, and the sample size was too small to establish a definitive pattern of defects. Additionally, the variability in patient outcomes made it difficult to attribute issues solely to the product.

– Hastings, who underwent a total hip replacement, alleged that the MoM product was

defective and sought damages under CPA.

SC Appeal = was there prima facie evidence giving rise to a non-rebuttable presumption proving Hasting’s case? – Professional concerns – Official Notices and Alerts – Product Withdrawal

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Interaction between the EU MDR and the EU product liability framework

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Supply chain potential product related liability broadened

Manufacturer, EU Authorised Representative, Importer

Distributor

Non-medical purpose device Manufacturer

Online seller Commercial online therapeutic or diagnostic services provider

EU MDR: Manufacturer of predicate products to which ‘equivalence’ is claimed

Reprocessor

Provider / User of a high-risk AI system for fault-based claims per EU AI Act and draft AI Liability Dir

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EU Authorised Representative liability for defective devices

• “[…] Given that pivotal role [as an EU contact person and ensuring compliance of devices with MDR] , for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations [in Art.10] . The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC [old PLD] , and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. (Recital (35))

− “[…] where the

manufacturer is not established in any

Member State, and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, jointly and severally with, the manufacturer ” ( Article 11(5) MDR)

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EU Authorised Representative liability for defective devices

Multiple uncertainties for ARs

How to monitor and ensure Art.10 compliance of Manufacturer clients?

Legal basis for liability per MS?

AR obligation to terminate the mandate if Manufacturer acts contrary to its MDR obligations (Art.11(3)(h))

Notify reasons to national Authority and Notified Body (if relevant) (Art.11(6))

Failure to terminate promptly for cause will expose AR to liability for defective products

Manufacturer-AR relationship likely to be under significant tension under MDR AR will pass on cost of increased risk profile and resource requirements to Manufacturer clients Obligation to notify ex-Manufacturer client of complaints or reports of suspected incidents continues after termination

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EU MDR - SUD Reprocessors

“ Any natural or legal person who reprocesses a single-use device [SUD] 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” (Art.17 (2) MDR)

– Reprocessor name and address must be labelled / included in IFU – Name and address of original SUD Manufacturer removed from label but stays in IFU – Scope for MSs to prohibit or regulate more strictly – Revised EU PLD: anyone that substantially modifies a product outside the original manufacturer’s control is considered a “manufacturer” for purposes of claims

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Facilitation by a Competent Authority

• Facilitation, by a competent authority, of the provision of information to persons who may have been injured by a defective device (Art.10(14)) – Subject to data protection rules – Subject to IP protections – unless overriding public interest in disclosure • No obligation on Authority if disclosure obtainable ordinarily in legal proceedings

Mfr obligation to provide info, docs, samples & access to the device to demonstrate conformity (Art.10(14))

Authority considers or has reason to believe a device has caused damage

Upon request the Authority shall facilitate provision of the above info & docs to (1) potentially injured patient (2) user (3) successors in title (4) patient’s or user’s health insurer (5) other third party affected by the damage to patient or user

Revised EU PLD and draft AILD allow court to order disclosure by D of necessary & proportionate evidence (also against 3P if AIaMD for negligence claims)

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Wide-ranging transparency in MDR

Summary of Safety & Clinical Performance (SSCP) • Class IIIs & Implantables

Recital (43)

•

“Transparency and adequate access to

•

Clinical Investigations (CIs) • Study Reports & Lay Summaries (no PD or CCI)

information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.” (NB: future Eudamed public availability may help protect against claimant requests for disclosure orders under revised EU PLD / draft AILD)

UDI database

• No UDI-PIs or CCI to be public BUT incl processing and label info + device status

EOs database • name, contacts, role, PRRC’s name & contacts

Devices database (?) • Incl markets, materials, CIs, contract mfrs, SCCP & device status

NB certificates • Suspended, w/drawn, reinstated, refused, restrictions

•

Vigilance & PMS • Appropriate public access to FSNs, serious incidents, PSURs, trend reports

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Interrelation of promotional claims and validated ‘intended purpose’, safety and performance

Promotion outside validated ‘intended purpose’, safety and performance is ‘off - label’

Undermines protective ringfence which validated “intended purpose,” safety, and performance provides against third party claims

Not covered by valid CE marking

• All product

claims should also align with the validated SSCP • Implantables and Class III medical devices and Class C and D IVDs

MDR: public Summary of Safety and Clinical Performance (SSCP) – Art.32 MDR, Art.29 IVDR:

All product claims should therefore align with ‘intended purpose’, safety and performance as validated by

Manufacturer, including oral statements, demonstrations and promotional materials

New EU PLD’s defect test: regulatory compliance is taken into account as one of the circumstances to be considered.

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Implications for product liability

• Supply chain players • PRRC • New EU disclosure orders

Visibility

Spotlight on device status as part of “defect” test

• NB certificates status • FSCA/FSN, etc

• IFU, SSCP, claims • “failure to warn” / information defects

Vigilance -v- Warnings

• Key importance of Technical Documentation

Evidencing compliance

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Any questions?

Elizabeth-Anne Larsen Senior Associate – Solicitor Advocate CMS Cameron McKenna Nabarro Olswang LLP T: +44(0)207 524 6115 E: elizabeth-anne.larsen@cms-cmno.com

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Advertising and promotion in the EU General and medical device specific requirements

Bonnie Clemence

Stuart Helmer

E: bonnie.clemence@cms-cmno.com

E: stuart.helmer@cms-cmno.com

T: +44 20 7367 2402

T: +44 20 7367 2687

CMS Cameron McKenna Nabarro Olswang LLP

4 December 2024

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Bonnie Clemence

Stuart Helmer

Senior Associate

UK Head of Advertising and Marketing

E : bonnie.clemence@cms-cmno.com

E : stuart.helmer@cms-cmno.com

T : +44 20 7367 2402

T : +44 20 7367 2687

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Overview

• General regulation of advertising in the EU/UK

• Medical device specific advertising regulation

Industry Codes

•

• Online: Social media and websites

• Transparency and anti-bribery

• EU harmonisation for medical devices advertising

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General regulation of advertising in the EU/UK

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Unfair Commercial Practices Directive

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Misleading and Comparative Advertising Directive

Bans misleading advertising

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• Sets rules for comparative advertising:

not misleading

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• same needs / same purpose

• material, relevant, verifiable* and representative features

• does not discredit or denigrate

• does not take unfair advantage

• does not present goods or services as imitations or replicas

• does not create confusion

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UK implementation

• Consumer Protection from Unfair Trading Regulations

• Business Protection from Misleading Marketing Regulations

CAP Codes

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• Claims addressed to consumers

• Rule 12 on medical devices (rule 11 in the BCAP Code)

ABHI Code

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• Claims addressed to HCPs

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UK implementation

• Consumer Protection from Unfair Trading Regulations

• Digital Markets, Competition and Consumers Act (from April 2025)

• Business Protection from Misleading Marketing Regulations

CAP Codes

•

• Claims addressed to consumers

• Rule 12 on medical devices (rule 11 in the BCAP Code)

ABHI Code

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• Claims addressed to HCPs

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EU implementation

• “Maximum harmonisation” – but...

Areas of inconsistency:

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• Enforcement

• Scope (eg non-consumer contracts)

• National law, eg taste and decency, contract law, IP, H&S etc

Vulnerability

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• Main characteristics of products

• Since Brexit – new EU rules on greenwashing and fake reviews

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Enforcement - UK

No competitor enforcement

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ASA/ABHI

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• Trading Standards – criminal or civil enforcement

CMA – from April:

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• direct enforcement

• Fines up to 10% of worldwide turnover

Consumer claims

•

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Enforcement - EU

• Competitor enforcement available in most countries

Unfair competition

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• Interim injunctions (esp Germany)

Consumer claims

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• Fines up to 4% (or more) of turnover for “widespread infringements”

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CAP Codes – general points

Obviously identifiable

•

Not misleading

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Substantiation

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Qualification

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Imitation and denigration

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Harm and offence

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Promotions

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• Environmental claims (“greenwashing”)

Light-touch remedies

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CAP Codes – medical devices

• Medical claims only for CE/UKCA marked devices

• But a CE/UKCA mark is not evidence of efficacy

• Take care with “borderline” claims

• High standard of substantiation:

• Rule – objective claims must be backed by evidence, if relevant consisting of trials conducted on people • Guidance – sensory/impressionistic subjective claims vs uncontroversial/established objective claims vs “new” objective claims

• Must not falsely claim that a product is able to cure illness, dysfunction or malformations

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ASA ruling Omega Pharma Ltd – 19 October 2022

• CE marked nasal cleansing spray

• “Each day we breath [sic] in millions of viruses which can lead to cold symptoms. Clean your nose every day with new BecoCleanse ... It cleanses away viruses and helps protect against winter symptoms” • ASA: implied claim that the product would protect against viruses and help prevent cold symptoms

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ASA ruling Omega Pharma Ltd – 19 October 2022

• High level of substantiation required

• 10 papers provided, including 4 RCTs

• Supported the underpinning concept ✓

• But RCTs flawed – 2 on nasal surgery patients, 1 not blinded, 1 on patients with cold symptoms (so could not study prevention of cold symptoms) 

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Medical device specific advertising regulation

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UK approach to medical devices advertising: high level view

Fairly liberal, subject to certain safeguards

Promotion to both HCPs and patients / consumers permitted

HCPs & Patients: same rules apply but execution of advertising must be tailored to the audience. Vulnerability of patients and carers must be respected!

Online advertising is permitted. Similar rules apply as for non-broadcast advertising

Sensitivity: Medical devices are within a very sensitive (and political) sector

Both legislative and self-regulatory regimes apply

Article 7 MDR-type (prohibition of misleading claims) – enforcement regime still under consideration

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UK medical device regulatory law & advertising

MHRA primarily responsible regulatory body

•

Advertising to HCPs and patients permitted, including professional use products

Currently aligned with MDD

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Broadcast and non-broadcast (inc. online) advertising permitted

• Article 7 MDR-type (prohibition of misleading claims) changes anticipated 2025: • MHRA advertising committee – ABHI representative attending with other industry sector representatives (e.g. ABPI) • MHRA may hand over oversight to Advertising Standards Authority (ASA)

Claims must align with CE/UKCA marked ‘intended purpose’

Vigilance obligations apply to Manufacturer elicited social media comment

Risk that online user-generated comments may promote off-label

UK MD Regulations 2002: “supply” includes offer, exposure or possession for supply

Pre-CE/UKCA Mark: No advance orders but budget discussions likely allowable

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EU MDR & advertising – Article 7 prohibition of misleading claims

Bites on activity as well as materials

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• Off-label promotion

• Positive representations

• Omissions / failure to warn

• Importance of aligning with CE marked intended purpose

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EU MDR & advertising – Article 32 Summary of Safety & Clinical Performance

• Alignment of advertising materials and promotional claims / statements • Periodic reviews and ad hoc reviews to maintain alignment

Implantables & Class IIIs

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‘Living document’

•

Content must include:

•

• the intended purpose of the device and any indications, contraindications and target populations

• possible diagnostic or therapeutic alternatives

• summary of clinical evaluation and relevant information on post-market clinical follow-up

• suggested profile and training for users

• information on any residual risks and any undesirable effects, warnings and precautions

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Industry Codes

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• ABHI Code of Ethical Business Practice (July 2019) Sector-Specific Advertising Regulation

MedTech Code of Ethical Business (March 2022)

•

• Focus mainly on interactions with HCPs, e.g.:

Implements MTE Code

•

• ABHI Guidelines on Advertisements & Promotions addressed solely or primarily to Healthcare Professionals

• Provision of educational & promotional items

Fills a regulatory ‘gap’ in:

•

• Provision of demos and samples

• CAP Code which excludes ‘marketing communications in media addressed only to

• Third party educational events

medical, dental, veterinary or allied practitioners, that relate to those practitioners' expertise’

• Grants & charitable donations

• UK implementation of EU general advertising law without any private law right of action for companies in the UK

• Consultancy agreements & research

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