1.
Are you ready for IVDR?
IVDR readiness check
By Oliver Eikenberg, PhD
Senior Consultant RA/QA
Oliver.Eikenberg@ul.com

2.
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MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE
ALWAYS AHEAD OF THE GAME.
“My QMS is world class”
“One stop shop for MDQMS”

3.
22 Years Ago We Saw …
We started with the medical device directives:
AIMD 90/385/EEC, MDD 93/42/EEC ….and IVDD 98/79/EC as initiated by the Council
Resolution on the “New Approach” to harmonize the essential requirements and
standards and to improve the industrial manufacturing for MD/IVDD.
The Directives have represented the common legal basis for placing MDs/IVDDs onto the
European market up to now.
2 guiding principles of the Directive are
• to provide patients, users and third parties with a high level of health protection and
• attain the performance levels originally attributed to them by the manufacturer.
The Directives were developed over several years and outlining the obligations of the
manufacturer and the performance of MDD/IVDD in general terms.
Necessary practical details are then supposed to be further considered in written
standards and other documents by a Committee on Standards and Technical
Regulations…. Technical Committee 140 of the European Committee for Standardization
(CEN TC 140) ….e.g. ISO 15189

4.
Ready or Not, compliance to
NEW Legacy Device Requirements in the EU
will need to be demonstrated very soon.
Yes
No
Not Sure
Is your company ready?
10-item IVDR readiness checklist.
NOW
2021

5.
1. Do you have a quality plan for documenting
your transition from IVDD to IVDR ?
Have you performed a gap analysis to identify
potential gaps between IVDD and IVDR ?

6.
ISO 13485:2016 and IVDR
The new IVDR is to be considered in line with
EN ISO 13485:2016 and includes multiple cross
references (e.g., Annexes to IVDD!)
• 4.2.3 Medical Device File
• 5.4 Quality objectives address the obligation to meet
ALL applicable regulatory requirements (REACH, WEE,
RoHs, CLP, GDPR…) next to UDI Software, Medical
Device File, User training, Post Market requirements
• A Quality Plan or equivalent needs to be established…
Key aspects
• Status of quality plan
• Resource planning
/Budget
• Training on IVDR
• Verification of IVDR
changes (audit)
• Update RM, TD, PMS
• Updates based on new
EC guidelines,
statements, standards

7.
Example Article 10 General obligations of manufacturers

8.
Readiness Question 1
Do you have a documented quality plan for
documenting your transition from IVDD to IVDR?
Do you have performed a gap analysis and
identified potential gaps between IVDD & IVDR?
☐ YES
☐ NO
☐ Not sure
Status of Actions ?
PLAN AHEAD
PUT your PLANS
into ACTIONS

9.
2/3. Check your Category/Class
Does your product qualify as a in vitro
diagnostic device under IVDR?
Does IVDR change the classifications of your
medical devices?

10.
No substantial changes in the current definition of an IVD…
NEW … software
Changes in IVDR definition- impact on IVD?
Key aspects
• Status - How to find out?
• Use current interpretations!
• Assess well in advance of
the IVDR application May
2022 whether your
products may fall under
the extended IVDR scope.
• If you are unsure, ask for
help and clarify your
categorization BEFORE
• entering the market!

11.
Examples for classification guidance
Guideline relating to the application of EU
Regulation 2017/746 addressing the
classification of IVDs and provides guidance
on the interpretation of the classification
rules as set out under Annex VIII.
Internal MDCG
document

12.
Example- Software might be classified as IVD
The IVDR also now includes in their definition “software,” and as a consequence software intended for IVD
might be classified as an accessory to the corresponding IVD, falling under IVDR!
NEW Guidance

13.
Chapter V
Classification and conformity assessment
✓ Instead of a „positive“ listing used for IVDD (List A, B)
✓ ...the IVDR uses a risk based classification system
based on the GHTF. Now 7 classification rules apply
and categorize the IVD with the new IVDR in risk-
related categories A, B, C, D

14.
Annex VII
New IVD classification scheme
D
Used for blood, cell, tissue or organ screening. Devices used to detect transmissible agents that cause life
threatening diseases, or infectious loads thereof.
RULE 1
Non-critical products and accessories for general lab use, including specimen receptacles. Instruments
specific to IVD procedures.
RULE 5 A
Devices not covered by Rules 1-5RULE 6 B
Devices which are controls without assigned values.RULE 7 B
Used for blood grouping or tissue typing to ensure immunological compatibility. Uses related to certain
high risk markers are Class D.
RULE 2 C D
Devices intended for self testing are Class C. Devices for testing pregnancy, fertility, cholesterol, glucose,
erythrocytes, leucocytes and bacteria in urine are Class B.
RULE 4 B C
Uses related to sexually transmitted diseases, infectious agent detection, companion diagnostics, cancer
screening, disease staging, human genetic testing and more.
RULE 3 C

15.
Readiness Question 2/3
Does the IVDR (MDR) may change categorization of your
products as MD or IVD?
☐ YES
☐ NO
☐ Not sure
Does the IVDR change classification of your products as IVD? ☐ YES
☐ NO
☐ Not sure

16.
4. Check your (Role of) Economic Operators
involved in the supply chain
Have you updated your quality agreements to
cover the new requirements for economic
operators (distributors, importers) and service
providers….change from OEM-PLM?

17.
Economic operators include manufacturers, distributors,
importers, suppliers, subcontractors, assemblers, and EU
Authorized Representatives, all of whom carry
responsibility for conformity to the regulations.
The new Regulation (articles 10, 11, 13, 14, 30) describes
obligations that must be carried by ALL involved parties,
including “what” and “how” — representing a major
increase in responsibilities for all stakeholders.
Role of Economic Operators in the supply chain
Key aspects
• Update of contracts /
Quality agreements.
(End of OEM-PLM)
• … - may only work if
economic operator
has ISO 9001 or ISO
13485
EUDAMED
Contrary to popular belief, the OBL alone assumes the total regulatory
responsibility for the device under the IVDR; the manufacturer is required
to hold a full copy of the TD at all times. This will have a severe impact on the
PLM (or OBL) business. (Art. 10.4)

18.
Examples
ANNEX II Technical Documentation
Sub-contractors
Are there any changes to sub-contractors related to the application?
• All significant sub-contractors/crucial suppliers must be added to associated QMS certificate(s) and the Unannounced
Audit Visit schedule. …
• Significant sub-contractors/crucial suppliers that do not hold a valid ISO 13485 certificate issued by an EU NB or one of its
direct subsidiaries (e.g. TUV Americas) may require a sub-contractor audit, depending on the scope of their activities and
the verification activities undertaken by the manufacturer. There may be instances where a verification visit is needed,
even if they hold ISO 13485 certification from a NB. Please ensure that these details are made clear in the application.
• If design is sub-contracted, control of this sub-contracted activity must be considered.
Current expectation from a NB

19.
Readiness Question 4
Have you updated your quality agreements to cover the new
requirements for economic operators (distributors,
importers, European AR)?
☐ YES
☐ NO
☐ Not sure

20.
5. Harmonized standards- new standards
Do you comply with current state of the art standards?
Do you need updated testing of your device to comply
with the current standards?

21.
Over many years references of harmonized standards for medical devices have been
published in the official journal of the European Union and these have reflected the
current status.
Since 1 December 2018 the references of harmonised standards are published in,
and withdrawn from the Official Journal of the European Union by means of
'Commission implementing decisions'.
The references published under Directive 98/79/EC on in vitro diagnostic medical
devices are found in Commission Implementing Decision (EU) 2020/439 of 24 March
2020 (OJ L 90I , 25 March 2020) listed below. The decision applies until 26 May 2024.
Check your compliance to current standards
Key aspects
• Several revisions of key
standards that
manufacturers use to
show compliance to
essential requirements
are expected for
MDR/IVDR….
• Risk Management
• Clinical Performance

22.
Since 2017 there had been many standards not officially listed in this “official journal”,
but applicable and often needed to demonstrate compliance to the essential
requirement (IVDD) and GSPR (IVDR).
But….Manufacturers “need” to consistently meet current state of the art technical
standards for compliance.
Background
The EC (technical committees, MDCG) has to review each revised standard against the
GSPR, there are ca. 140 standards on their list …this might take some time
e.g. risk management for medical device ISO 14971 of the 3rd edition published along
with its technical report [ISO 24971]
the ISO20916:2019 standard for clinical performance/study.
These new standards are not on the published list
Consequence

23.
Readiness Question 5
Do you comply with current state of the art standards?
Do you need updated testing of your device to comply with
the current standards?
☐ YES
☐ NO
☐ Not sure

24.
6. Check your status of scientific, analytical and
clinical performance data
Do you have a performance evaluation plan
addressing scientific validity, analytical and
clinical performance evaluation ?
Do you have ongoing clinical investigations, and
have you considered the new
ISO 20916 and ISO 14971 standards?

25.
What do these terms mean?
✓ Scientific validity of an analyte means the association of an analyte to a clinical condition or a
physiological state;
✓ Analytical performance means the ability of a device to correctly detect or measure a particular
analyte
✓ Clinical performance means the ability of a device to yield results that are correlated with a
particular clinical condition or a physiological or pathological process or state in accordance with
the target population and intended user
Note: For external performance evaluation the applicable harmonized standard as listed in the
'Commission implementing decisions’ is EN 13612:2002, but ISO 20916:2019 applicable under IVDR
There are also GHTF guidance documents that can be used;
–Clinical Performance Studies for In Vitro Diagnostic Medical devices
–Clinical Evidence for IVD Medical Devices –Key Definitions and concepts
–Clinical Evidence for IVD Medical Devices –Scientific Validity determination and Performance Evaluation

26.
✓ Expectations to include clinical data for IVDs have increased
✓ Clinical claims will need to be supported by data and specific
reports depending on the risk of your device for all 3 pillars
✓ Clinical Evidence must be justified by data and conclusions
✓ Clinical Evidence must be continuously kept up to date to ensure
devices remain state of the art. This includes PMS.
✓ Follow a performance evaluation plan
✓ Performance evaluation report needed
✓ Summary of Safety and Performance Required for Class C + D
✓ Notified Body will look into data AND methodology!
Major changes for clinical data
Key aspects
• Check adequateness for
state of the art (literature).
• Check if NEW ISO 20916 is
followed and analytical &
clinical performance is up to
date.
• Show interaction of PER-
PMS-PMPF-RM.

27.
Readiness Question 6
Do you have a performance evaluation plan addressing scientific
validity, analytical an clinical performance evaluation ?
Do you have ongoing clinical investigations, and have you
considered the new ISO 20916 and ISO 14971 standard?
☐ YES
☐ NO
☐ Not sure

28.
7. Check your status of PMS and PMPF
Do you have a post-market surveillance plan in
place reflecting IVDR Annex III, and specifically
establishing a proactive and systematic process
to collect any PMS-related information?
Do you have a post-market performance follow-
up plan in place reflecting IVDR Annex XIII?

29.
PMS is not new , but getting more complex and linked to PMPF
requirements…. And reflect the regulatory lifecycle and risk-based thinking
of modern IVD regulations.
PMS must be understood and set up as a system collecting continuous and
proactively feedback about the IVD from the market(s)….instead of reactive
feedback e.g. through complaint monitoring.
PMS plan (Art. 78/79/80) covering proactive and passive activities to collect and
analyse market-related experience including disclosure of methods and protocols to
manage those post-market activities
PMS report which summarises the results and conclusions of the post-market
surveillance data.
Post-market performance follow-up plan (PMPF plan, Annex XIII, Part B) or a
justification as to why a PMPF is not applicable (outlined in the PMS plan)
Periodic Safety Update Report for classes C and D: report of analysis of data + rationale
for and description of, any preventive and corrective actions taken (at least annual update)
+ specifics for class D… (PSUR, Art. 81).
Post Market Surveillance (PMS) and Post Market Clinical
Follow-up (PMCF) -what is new?
Key aspects
• Multiple IVDR-elements
relate to “planning” like
the PMS Plan, PEP,
PMPF-Plan.
• This require robust QMS
procedures.
• Show interaction of
PER-PMS-PMPF-RM.

30.
Post-market surveillance plan and PMPF
✓Necessary for each device
✓Part of product life cycle approach and clinical evidence
✓Collect information on specific subjects (incidents, trending,
complaints, feedback etc.) and evaluate safety and
performance
✓Define how to systematically evaluate information and
continuous reflection on risk management
✓Perform clinical risk/benefit assessment
✓Record in the PMS report, part of Technical Documentation
✓PMPF is part of PMS as a continuous process to update
clinical performance data
Start developing your
PMS plans NOW,
they may generate
valuable information for
your transition to the
IVDR.

31.
Readiness Question 7
Do you have a post-market surveillance plan in place reflecting
IVDR Annex III, and specifically establishing a proactive and
systematic process to collect any PMS-related information?
Do you have a post-market performance follow-up plan in place
reflecting IVDR Annex XIII?
☐ YES
☐ NO
☐ Not sure

32.
8. Technical Documentation structure
Have you updated your Technical Documentation
Structure?
Have you updated your ER-checklist to GSPR
requirements?
Do you have a dedicated, qualified responsible
person?

33.
TD has been extended and clarified in many aspects for documentation content….
format might be STED, but should include new elements (clinical evidence, GSPR,
PMS plan and report, PMPF, PSUR).
All documents of the TD must be well structured and organized and clearly
identifiable for reviewers, decisions must be justified e.g. risk-based approach.
GSPR replaces the Directive’s ER. Manufacturers will have to consider how to
demonstrate compliance through RM, testing, technical studies, and other means.
For Class C and D devices, manufacturers must create a summary of safety and
performance (SSP). The summary must be written in a way that is clear to the
intended user.
e.g. should include … “reference to any harmonised standards and CS applied”
Technical Documentation structure (Annex II and III, Art 10)
General Safety and Performance Requirements (Annex I)
Summary of Safety and Performance (Art 29)
Key aspects:
• Change TD structure
• Udate ER to GSPR
• Include rationales

34.
Technical
Documentation
Design history file
Risk Management
File
PMS Report
PSUR
Clinical Performance
Report
PMPF studies
Vigilance related
data
Non-vigilance
related data
Performance
Evaluation Report
Check your compliance

35.
Responsible person
Art 15 defines qualifications - MUST be qualified
Generally should be available inside the organization
Should be „within their organization“ means…exempt for small
enterprise without definition of “small”….
Comparison to Safety Officer (Germany, § 30 MPG)
Key aspects
• Identify responsible
person
• Check qualifications
• Change Organigram
• Appointment letter
Responsibility MDR / IVDR MPG
Check Conformity of MD^/IVD X —
Technical Documentation (incl. Continous Updates) X —
Post Market Surveillance X X
Registration X X

36.
Readiness Question 8
Have you updated your Technical Documentation Structure?
Have you updated your ER-checklist to GSPR requirements?
Do you have a dedicated, qualified responsible person?
☐ YES
☐ NO
☐ Not sure

37.
9. EUDAMED (UDI, data entry, vigilance)
Are you and your economic operators prepared for
UDI and data entry into EUDAMED?

38.
EUDAMED will manage data for:
✓ Devices (Unique Device Identifiers (UDI))
✓ Certification (e.g. CE markings)
✓ Clinical Investigations
✓ Manufacturers and importers — identified by SRN
✓ Notified Body accreditation and designation
✓ Extended vigilance data, including PMS
✓ Applications for conformity assessment by NB
✓ Summaries of safety and clinical performance
✓ Performance studies for IVDs (like clinical investigations)
✓ Market surveillance data
Key aspects
• Prepare for UDI
• EUDAMEDentry might be later (2022)
• Check Medical Device Coordination
Group documents MDCG 2019-4
“Timelines for registration of device data
elements in EUDAMED, 5 “Registration of
legacy devices in EUDAMED,” etc.

39.
Further Eudamed considerations:
Eudamed will be public facing ! EUDAMED will be open to many more groups, EC,
National CA, AR, Notified Bodies, Manufacturers, Importers, and Sponsors….(current
estimate >70000+ individual organisations, >300000 actual users).

40.
Readiness Question 9
Are you and your economic operators prepared for UDI and
data entry into EUDAMED?
☐ YES
☐ NO
☐ Not sure

41.
10. Notified bodies
Have you confirmed that your Notified Body will be
designated to IVDR, or
will you need to change your NB?

42.
Supervision of NB changed considerably.
Unannounced audits of manufacturers and AR increased.
Surveillance assessments might include a test of the approved parts
and/or materials essential for the integrity of the device, including a
check that the quantity of purchased parts corresponds with the
quantity of finished devices….and more.
A significant number of NBs may not be re-notified, or may not be
notified for the same scope, which could force some medical device
manufacturers to change NBs.
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
Current situation - Capacity vs. Workload
Key aspects
• Less NBs have to
manage more work….
• Expected number of
NBs in the next
month unclear….
• Early interaction with
your NB or a new NB
is key!
• Ask for timelines!
• Be prepared to
deliver needed
documents upfront!

43.
Current situation - Capacity vs. Workload

44.
Readiness Question 10
Have you confirmed that your Notified Body will be designated
to IVDR, or will you need to change your NB?
☐ YES
☐ NO
☐ Not sure

45.
Avoid the IVDR deadline becoming
a flatline for YOUR IVD.
So where are you today on this route to EU-compliance?

46.
Questions?
Emergo by UL can assist you in Europe and 23 other markets worldwide.
My contact information:
Oliver Eikenberg, PhD
Senior Consultant RA/QA
Oliver.Eikenberg@ul.com
EmergobyUL.com