2021 01 22 - DIAGNED IVDR webinar handouts

Economic Operator
AUTHORIZED REPRESENTATIVE

See Article 12.

SWEXIT-->
Switzerland

TrBio IVDR: topic 2: 15-01-2020 Slide 53

Economic Operator
IMPORTER

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

• See article 13

Slide 54

Economic Operator
IMPORTER

• See article 13

55

Economic Operator
DISTRIBUTOR

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

•See article 14

56

Economic Operator
DISTRIBUTOR

Clear new requirements for Distributors (Article 14):
Responsible to contact CA when problems are noted.

• See article 14

HOW will the control of
distributors be executed ??
By whom?

57

IVDR
Principle of PMS and PMPF

DIAGNED IVDR workshop: 22-01-2021 58

New IVDR
Hot Topic

Requirements for a person responsible for regulatory compliance

– Liability
– Independent : No –disadvantage for executing tasks
– Responsibilities: many
– In EUDAMED

DIAGNED IVDR workshop: 22-01-2021 59

Economic Operator
PRRC

• See article 15

60

Economic Operator
PRRC

MDCG 2019-7

• See article 15:

Liability issues?

61

Economic Operator
Cases in which obligations of manufcaturers appy to

importers, distributors or other persons

• See article 16

62

Economic operators/distributors/
Autorised Rep/ Importer

Inside the EU manufac AR Importer Dist
X - - eisen zie *
outside the EU
Mandate outside EU X X identified X
CE mark X X Verify -
EU declaration X - Verify Verify *
technical documentation X Verify+copy Verify *
conformity assessment X Verify+copy Verify+copy -
Certificates (X) check - -
Eudamed (X) copy - -
Labelling en IFU X X X -
UDI X X X X
terminates mandate X Verify X X
Product liability - X X -
record keeping (10 years) X X last option - -
Rules for change X X - -
Free Samples X X X -
Verification of X Not free - X (a CA) *
Non compliance with CE - - importer on label
Risk after placing on the market - - X (the CA) M (AR + I)
serious risk after placing on the market X - AR and mandate inform M (AR + I)
all info on request X - all CA's involved
? X in requested EU M + AR -
inform M (AR)
language all CA's involved 65

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DIAGNED IVDR workshop: 22-01-2021

Economic Operator 66
Manufacturer/ Importer/Distributor/ EU Rep

CASE STUDY: 1) USA Based companyà legal
manufacturer: same products as samples used
before
Group 1 : Manufacturer (article 10)
Group 2 : Authorized Rep (article 11, and 12)
Group 3 : Importer (article 13)
Group 4 : Distributor (article 14)
Extra: Person Responsible for regulatory
requirements (Article 15) needed in group 1, 2 3 and
4??

DIAGNED IVDR workshop: 22-01-
2021

Distribitor, Importer, EU rep?

Requirements for a distributor

– Liability?
– Am I an Importer? What do I need to do?

• Register in Eudamed?
• Control mandate/Contract
• Control distributors
• Control Manufacturer
• Free Sample available
• Extra label requirement ; name details address available on product

– Am I an EU rep? What do I need to do?

• Register in Eudamed
• Contract/Mandate
• Technical documentation of Tech files

– Am I a distributor only? What do I need to do?

• Register in eudamed? NO
• Control Manufacturer! DoC : CE certs classification and scope of the products : Not allowed to sell out of

scope of CE cert.
• Free sample potential for CA

DIAGNED IVDR workshop: 22-01-2021 67

Economic Operator
Manufacturer/ Importer/Distributor/ EU Rep
CASE STUDY: 1)
- USA Based companyà legal manufacturer: same
products as samples used before

Group 1 : Manufacturer (article 10):à PRRC, EUDAMED; CONTRACTS/mandates:
Liability insurance: Check EU rep, Check importer, Check distributor
Group 2 : Authorized Rep (article 11, and 12):à EUDAMED, MANDATE/Contract
à PRRC, QMS up to date and in place for checking requirements: Tech

documentation available: Check manufacturer compliance

Extra: Person Responsible for regulatory requirements (Article 15)
needed in group 1, 2 3 and 4??

DIAGNED IVDR workshop: 22-01-2021 68

Economic Operator
Manufacturer/ Importer/Distributor/ EU Rep

CASE STUDY: 1)
- USA Based companyà legal manufacturer: same products as samples

used before
Group 3: Importer (article 13): à CONTRACT: EUDAMED: check manufacturer’s documents and

compliance; DoC, product classification CE certs? Check EU REP activities; ETC: SPECIFIC label importers info on
product / or available near product: provide samples of the devices free of charge for CA ; complaints-incident
reporting

Group 4: Distributor (article 14):à CONTRACT: check manufacturer’s documents and

compliance: DoC, product classification CE certs valid: WITHIN SCOPE? / complaints –incident reporting

Extra: Person Responsible for regulatory requirements (Article 15) needed
in group 1, 2 3 and 4??

DIAGNED IVDR workshop: 22-01-2021 69

Unique Device Identifier
Eudamed database

DIAGNED IVDR workshop: 22-01-2021 70

EUDAMED UDI

“Basic UDI-DI” is the most important KEY for access to the data within the EUDAMED 71
DIAGNED IVDR workshop: 22-01-2021

UDI EUDAMED

• Economic operators are identified by a Single Registration Number (SRN) – NL-MF-
123456789

• Products are identified by the UDI
• Clinical Performance Studies are identified by Single Identification Number (SIN)
• Reporting and FSCAs get Case numbers
• Free of charges a nomenclature number becomes available EMDN (not GMDN codes

but the Italian CND-codes)
• Nomenclature for incidents (potential IMDRF?)
FOCUS:
• GUIDANCE by EU Commission on this implementation

DIAGNED IVDR workshop: 22-01-2021 73

UDI EUDAMED

https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/ 74

md_actor_module_q-a_en.pdf

DIAGNED IVDR workshop: 22-01-2021

UDI EUDAMED

DIAGNED IVDR workshop: 22-01-2021 75

UDI Timelines

DIAGNED IVDR workshop: 22-01-2021 76

Regulatory Strategy needed for economic operators

STRATEGY NEEDED and implemented à 26 May 2022

• For Manufacturers of Current CE-IVD

– Upgrade to IVDRà most up-classified Class B and Class C
– Phase out of current products?
Example Covid-19 test: from self-declared to Class D.

• For Distributors /Importers of selling current CE-IVDs

– Do I have my QMS adjusted to the requirements of Article 13 and 14 of IVDR
– Process for checking all required documents
– PMS process in place for timelu report
– Upgrade to IVDR product à informed by HQ timely mannerà most up-classified Class B and Class C
– Phase out of current products? Inform customers?

• And Health Institutions with

1) CE-IVDs and
2) In house developed test what do they have need to update?

Example Covid-19 test: from self-declared to Class D.

DIAGNED IVDR workshop: 22-01-2021 77

Strategy Manufacturers:

ACTIONS: Current manufacturers of IVD’s

• Portfolio analysis:

– Products phased out under IVDD: soft transition possible for List A and B products?

Will this be communicated to the distributors and Health Institutions?
– Product transferred to IVDR:
• à self-declared as of 26 May 2022 (example COVID-19 test)
• à List A and B: IVDD cert valid until max 26 may 2024
– New approach for specific compounds? à collaboration with Health Institution?

– IVDD-IVDR: Major impact for Manufacturer to comply to IVDR this fast:

LARGE IVD manufacturer: all range IVD products:
• Currently IVDD: 4% notified body à
• Soon: IVDR 92 % notified body. à Will they transfer all product to be IVDR or Phase out?

DIAGNED IVDR workshop: 22-01-2021 78

Strategy Distributors and manufacturers:
IVDR compliance:

• Portfolio analysis of current products à will they be available in time

• Make a Regulatory strategy plan taken in to account à Manufacturers and
Health Institution needs and requirements.

• Fill the “warehouse” with “old product “ as distributor full as of 25 May
2022!.

• Communicate with HQ and with Health institurions (as they have to make it
in-house otherwise)

• Communication, Recognition the situation of each other and
Collaboration between the parties is Key:
Needed in order to serve the patient safety and performance as of
26 May 2022

DIAGNED IVDR workshop: 22-01-2021 79

Take home message

SAFETY and Performance for CE marking
• GAP Assessment and time schedule: à ask Communicate with HQ.

• Manufacturer is in control: Always!
• Distributor/ sales marketing organisation has to control the legal manufacturer:

not allowed to sell “off label” and not when there is no CE cert. à liability
• Marketing materials are part of product (and under control of legal

manufacturer)à translation control
• EUDAMED: for Legal manufacturer, EU Rep, Importer and PRRC
• Ask when the CE certs for your product are ready and available for you to sell it.
• Fill the “warehouse” with “old product “ as distributor before 25 May 2022!.

DIAGNED IVDR workshop: 22-01-2021 80

DIAGNED IVDR workshop: 22-01-2021 81

Questions?

And which questions do you want to get an answer to?

- TD content and how NoBo’s review it : Standard text? : Annex I Annex II, PMS Annex III
- Registration documentation: eudamed
- Country affiliate as marketing and Sales organisation: requirements: discussed
- Local customization process (legal manufacturer? Of not?): article 16
- Requirements for PMS/ vigilance? : Much extra update PMPF process PMS process

PSUR : Annex III. : reporting timeline 2-10-15 days
- Impact for business partners in the complete chain: discussed
- Consequences of new requirements as importer/distributor: discussed
- Economic operators requirements: discussed
- Notified body alignment , technical doc update, labelling changesà translation

requirements? : align in Team NB lost of template documents via MDCG guidance
documents

DIAGNED IVDR workshop: 22-01-2021 82

Questions?

And which questions do you want to get an answer to?

• IVDD instruments in het veld en IVDR reagents, die door de manufacturer niet gevalideerd zijn
op de IVDD legacy instrumenten, hoe kan dit door de gebruiker alsnog als IVD worden gebruikt
op deze IVDD legacy instrumenten? Het ganse installed base kan onmogelijk worden vervangen
op korte tijd door IVDR instrumenten...

• Registratieverplichtingen, verificatieverplichtingen levering van 3e-partijen.

• Zijn er mogelijkheden om deze richtlijnen te omzeilen door de gebruiker?

• IVDR in relatie tot LDT

• IVD

• UDI eisen

• ‘’ Verschillen tussen de verschillende economic operators. Verantwoordelijkheden voor de EC
Rep"

• UDI en Basic-UDI en het verschil

• Algemeen kennis niveau op peilen houden

• Wat zijn de gevolgen van IVDR voor leveranciers en voor klanten? In welke gevallen hoeft er niet
aan IVDR gehouden te worden en in welke gevallen wel?

• Tijdslijn en vertraging EC

• Hoe wordt er gecontroleerd vanuit de inspectie en of accreditatie op de implementatie

DIAGNED IVDR workshop: 22-01-2021 83

IMPLEMENTATION IVDR
Be prepared and enjoy the RIDE

. 84
DIAGNED IVDR workshop: 22-01-2021

Questions?

DIAGNED IVDR workshop: 22-01-2021 85

Questions?

Contact:
Anja Wiersma,
mi-CE consultancy
Kerkstraat 30 A
6675 BS Valburg
The Netherlands
www.mi-CE.nl
[email protected]

MEETING THE STANDARDS, LEADING THE WAY. 86

DIAGNED IVDR workshop: 22-01-2021