We are prepared for MDR – are you?

Hartelijk welkombij de deelsessieover de MDR

Inhoud

1. Introductie

2. Essity in het kort

3. Waarom MDR?

4. Essity’s MDR project➢ Project facts

➢ Document and label updates

➢ Collaboration with Suppliers and Distributors

➢ Assessment by Notified Body

➢ What we have achieved

5. Essity’s boodschap aan klanten

February 11, 2020

MDR

Patients' Safety First

Even voorstellen

▪ Jenny Wennerberg – Global Regulatory Affairs Director

o ‘Key-member' van het MDR projectteam en verantwoordelijk voor het implementeren van de nieuwe MDR

richtlijnen bij Essity.

▪ Marcel Buijs – Field Sales Manager Ziekenhuizen

o Verantwoordelijk voor het ziekenhuisteam in de noordelijke helft van het land

February 11, 20205

Relatief nieuwe naam, maar met een rijke historie.....

Geschiedenis van waardecreatie

20111950 1975

19951929

2001 2013

2007 2012 2014

1800 1900 2000

2016

2017

1849 2018

Essity, waar staan wij voor?

Wij ontwikkelen, produceren en verkopen producten en diensten op het gebied van:

▪ Hygiëne

▪ Algemene wondverzorging

▪ Geavanceerde wondverzorging

▪ Continentiezorg

▪ Non invasieve orthopedie

▪ Compressietherapie

Wereldwijd produceren 20 fabrieken deze producten

500 miljoen mensen wereldwijd komen dagelijks in contact met onze producten.

Wij leveren hiermee een bijdrage aan de kwaliteit van leven.

February 11, 20208

Essity productcategorieën & merken

Incontinence Products

Professional Hygiene

Consumer Tissue

Medical Solutions

Baby Care

Feminine Care

Essity in Nederland

▪ BU Consumer:

▪ BU Professional Hygiene:

▪ BU Health & Medical Solutions:

Essity heeft drie Business Units

February 11, 202010

Essity MDR quizzzzz!

▪ MDR regelgeving is best wel ‘taaie kost’ …..

▪ Om het wat levendig en interactief te houden is er een MDR quiz tijdens de presentatie

▪ Daarvoor hebben jullie twee Essity petjes gekregen.

▪ Bij iedere vraag kan je een antwoord geven door de juiste kleur petje op te zetten

▪ Diegene die de juiste kleur op zet gaat door naar de volgende ronde

▪ Aan het eind blijven zo een aantal gelukkige winnaars over en die ontvangen een fantastische prijs........

February 11, 202011

Essity MDR quiz!

▪ Hoeveel Essity producten komen met de nieuwe MDR richtlijnen in aanraking?

▪ Meer of minder dan 25.000 artikelen?

February 11, 202012

Why MDR

Why a new regulation?

February 11, 202014

▪ Scandals

▪ Old medical device directive from 1993

─ new types of devices (active devices, apps etc)

▪ Big differences in requirements in Europe, US and other jurisdictions

When will MDR be applied?

15

* Transition period to designate Notified Bodies and update certificates.

** Grace period for higher class devices to continue to be placed on the market (if no significant changes and if still under a valid

MDD certificate).

May 2025

All

medical devices

shall bear

the UDI data

February 11, 2020

The main benefits with MDR

16

M A N Y D ATA I N C L U D E D I N A U N I Q U E E U R O P E A N D ATA B A S E ( E U D A M E D )

February 11, 2020

Essity MDR quiz!

▪ De EUDAMED is een belangrijke instantie binnen de nieuwe MDR regelgeving.

▪ Is de EUDAMED bedoeld voor informatie uitwisseling of ook als controlerende instantie?

February 11, 202017

EUDAMED – transparency of information

18

Uncertainties:

• Functionality of EUDAMED (~60% ready)

• All UDI attributes not yet defined

• Identification and interpretation of content

• Unnecessary national databases replacing

EUDAMED during absence

February 11, 2020

EUDAMED registration and UDI data

EUDAMED requirements:

▪ Initial registration of >70 attributes per device

▪ Resubmission upon changes to devices

19

• Countries where device is made available

• Status of device (on the market)

• Recall/FSCA

Market info

• Manufacturer

• Authorized representative

• Importer

• Notified Body

Economic Operators

• Active

• Substances

• Sterile/to be sterilized before use

• Single use

• Implantable

• Clinical size

• Maximum number of reuses

Device characteristics

• Certificates

• Clinical Investigations

Certificates and Clinical

• UDI

• Critical warnings and contraindications

• Storage and handling conditions

Labelling info

February 11, 2020

Essity´s MDR project

Essity MDR quiz!

▪ Essity heeft 45.000 producten in haar assortiment

▪ Hoeveel procent van deze producten hebben met de MDR te maken?

▪ Minder dan 80% of meer dan 80%?

February 11, 202021

Essity´s internal MDR projectReality check before the MDR project was started - challenges

February 11, 202022

▪ Diversity of device types; 4 therapeutic areas

─ Orthopedics

─ Vascular

─ Wound care (Acute and Advanced)

─ Incontinence care

▪ Products long time on the market - long before MDR and MDD

▪ Broad assortment with many variants

▪ Global organization

Ortho

AcWC

Vascular

Product families per TA – Medical (inco excluded)

Essity´s internal MDR project

February 11, 202023

▪ > 30 000 articles grouped in >700 Product families

▪ 250 team members globally – every function within the company!

─ 50 persons - Core team, full time

─ 100 persons - ~50%

─ 100 persons - <50%

▪ Budget: ~30 million €

▪ Timeline: 2017 - 2024

▪ Own factories

▪ 3rd part suppliers

▪ Internal and external distributors

Essity MDR quiz!

▪ Binnen de nieuwe MDR worden producten ingedeeld in (sub)risicoclassificaties

▪ Hoeveel (sub)risicoclassificaties kent de MDR?

▪ Meer of minder dan 4?

February 11, 202024

MDR risk classes

25

Class ILow risk devices

e.g. incontinence pads,

fixation tapes,

compression stockings,

orthopedic casts

Class IrReprocessed class I

devices

Class IIbe.g. wound dressings

for hard-to-heal wounds

Class IIIHigh risk devices incl.

E.g. animal/human

tissues, pharma

e.g. collagen wound

dressings

Class IIae.g. sterile first aid

dressings, surgical

dressing

Class ImClass I devices with a

measuring function

Class IsSterile class I devices

e.g. sterile elastic

bandages

TENA

Leukoplast

Elastomull

Fixomull

Fixomull stretch

Actimove

Jobst

Delta Cast

Leukomed

Leukoplast

Leukosan strip

-- Cutisoft

Cutimed

Sorbact

Leukomed

Control

Cutimed

Sorbion

Cuticell Classic

Cutimed

Hydrocontrol

Cutimed Epiona

February 11, 2020

Internal

Documentation

26 February 11, 2020

Internal documentation updateManufacturers

27

What do manufacturers need to do:

▪ Update the Quality Management System

▪ Update technical documentation, production related documents

▪ Test and validate

Do we not have this already?

▪ Increasing requirements

▪ No grandfathering

▪ Changes to roles and responsibilities

February 11, 2020

An example

February 11, 202028

Technical File -Design

• Regulatory Assessment

• Design Input/Requirements

• Usability

• Risk Management File

• Biological evaluation

• Clinical Evaluation

• Standards

• Design Output

• Artwork /Label & Instruction For Use

• Product Specification

• Shelf Life/Stability

• Post Market Surveillance

• Design Verification & Validation

• DHF

• DMR

Technical File -Production

• Agreement

• Specifications

• Instructions

• Printing new symbols

• Printing UDI code

• Software validation

• Process Validation

Essity MDR quiz!

▪ Alle productverpakkingen moeten onder de nieuwe MDR regelgeving voorzien worden van nieuwe symbolen

en informatie zoals MD en UDI

▪ Moeten deze veranderingen op de verpakkingen tegelijk worden doorgevoerd of niet?

29 February 11, 2020

▪ The MD symbol

▪ The UDI Carrier

- Machine readable (data Matrix or bar code)

- Human readable

Symbols and UDI carrier

February 11, 202030

How can UDI provide benefits for customers?

→ Cost saving

→ Accurate data

→ Full traceability

→ No stock out

February 11, 202031

• Stock level planning

• Expiry dates

• Searchable product characteristics

Hospital Purchasing

• Automatic data transfer between systems

• Expiry dates

• Storage conditions

• Traceability

HospitalWarehousing

• Automatic data transfer to patient´s file

• Expiry date

• Critical warnings and contraindications

Healthcare professionals

Collaboration with

Suppliers &

Distributors

32 February 11, 2020

SuppliersIncreased demand on suppliers, contract manufacturers and OEM

33

Important factors for continued collaboration:

▪ Understanding of new requirements

▪ Agreement on roles and responsibilities

▪ Document exchange

▪ Supplier audits

▪ Involvement with their notified body

Reality

▪ Unable to comply with new requirements

▪ Unprofitable business - suppliers will close down their business

February 11, 2020

Distributors

Some of the distributor´s obligations:

▪ Control the medical devices they sell (CE mark, UDI, product information)

▪ Storage and transport conditions

▪ Traceability

▪ Complaints, recalls and falsified medical devices

▪ Transitional provisions until May 2025

Increased demand on distributors

34 February 11, 2020

Notified Bodies

35 February 11, 2020

Essity MDR quiz!

▪ Hoeveel notified bodies van de 70 zijn er klaar voor MDR?

▪ Meer of minder dan 15?

February 11, 202036

Notified Bodies

New demands

▪ Extremely high demands on competence to assess a device

▪ Number of designated Notified Bodies decreased from >70 to ?

─ At the moment only 9 (3 more to come soon)

What does it mean for us?

▪ No/limited possibility to plan when devices can be CE marked in accordance with MDR

▪ Higher demands on documentation, tests, evidences etc.

▪ Re-certification

▪ Regular audits, unannounced audits, authority inspections

Increased demands on Notified Bodies

37 February 11, 2020

Outcome –

What we have

achieved and where

are we?

38 February 11, 2020

Where we are with less than 4 months left

▪ Updates of Technical Files - ongoing

▪ Notified Body audit in March for higher class devices

▪ Production, stock building and distribution started

▪ Communication with customers

▪ Procurement and delivery planning

▪ Collection of UDI attributes - ongoing

Achievements and Status

39

February 11, 2020

Where we are with less than 4 months left

▪ Supplier might go out of business in the coming years

▪ The huge deadline for all class I devices in May 2020:

─ Medical device and raw materials production

─ Accumulated transportation and distribution

Disclaimer:

We can´t avoid backorders completely – new production of all devices at the same time. No stock

building of old devices.

We will stay in close communication with customers if unexpected situations occurs

Still challenges

40 February 11, 2020

Essity MDR quiz!

▪ De MDR heeft gevolgen voor de kosten om producten beschikbaar te krijgen voor de gezondheidszorg markt

▪ Onderdeel van deze extra kosten zijn de notified bodies

▪ Wat is de kostenstijging bij de notified bodies door de MDR richtlijnen voor de fabrikanten?

▪ Minder dan 25%, of meer dan 25%?

February 11, 202041

Product discontinuation

First analysis:

▪ Cost for upgrading a device to MDR

▪ Profit per device

▪ Necessity of the product

▪ Equivalent devices

▪ Total number of sold units per device

▪ Procurement possibilities/supplier situation

Process:

▪ Suggest devices to be discontinued

▪ Find replacement devices

▪ Communicate externally

42

Distribution

€€ € €

€ € €€

Documentation &

Clinical data

Certification &

Sampling

Post market

surveillance

Manufacturing

Distribution

February 11, 2020

Essity´s message to customers

44 February 11, 2020

Essity cares about our customers

Essity upgrades product assortment within given timelines

▪ Start selling MDR conform class I medical devices in the beginning

of 2020

▪ Compliance with the MDR as of 26th May 2020

▪ Transitional provisions until 2025

MDR 202045

Recommendation:

▪ If customers experience a situation of non-delivery

from other suppliers, Essity will offer support to convert

to a suitable MDR-compliant Essity assortment

alternative as far as possible.

February 11, 2020

We are prepared for MDR!

Are you?

Thank you!