48
We are prepared for MDR – are you?
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!
