This session will discuss the one year delay of the MDR date of application as well as some strategies to employ during the MDR Transition. In addition, some approaches for determining documents to prioritize for the transition will be discussed. This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

1. Prioritizing Documentation for
MDR Transition Planning
Evangeline Loh, Ph.D., RAC (US, EU), June 2020
Emergo by UL and the Emergo by UL logo are trademarks of Emergo Global Consulting LLC © 2020.

2. “Greenlight Guru Software is the handrail for Medical
Device Development and Documentation”
FEATURED
IN
75
years
industry
experience
275k
podcast
listeners
#1
blog and
podcast in
the industry
90k
look to us for the
latest in medical
device quality
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. I. Background
Emergo MDR Readiness Checklist
Categories of Devices
II. Documentation Prioritization related to regulatory strategy
Regulatory Strategy and Clinical Strategy + Gap Analysis + Business Portfolio
III. PMS (Chapter VII, Annex III)
QSP PMS and Vigilance, PMS templates: PMS Plan, PMS Report, and PSUR
IV. Technical Documentation (Annex II)
GSPR Checklist, MDR TDF, and CER
V. Recommendations
Symbols, Standards and Guidance
VI. Conclusion
Agenda

4. I. Background

5. • Series of questions to help the manufacturer consider
the MDR
• Quality Plan (Item 5) is pivotal
• Have you performed a gap analysis and identified
potential gaps between MDD and MDR? Do you
have a quality plan for your transition (QMS and
Technical documentation) from MDD to MDR?
• Describe and organize the important aspects of
compliance, functional areas, responsibilities
• EU COMM Implementation Model for Medical
Devices Regulation - Step by Step Guide
20/11/2018
MDR Readiness Checklist

6. MDR Readiness Checklist
• Regulatory Strategy Questions based on classification
• Class I SC (Item 2)
• Class I SC MDD upclassified MDR (Item 3)
• NB issued MDD CE marking certificates (Item 4)
• PMS (Item 10)
• GSPR Checklist (Item 6)
• CER (Item 7)
• TDF (Item 8)

7. ‘Early’ MDR certification
• Class I SC MDD Class I SC MDR
• New devices
• Annex XVI devices, but only once Common
Specifications (CS) have been adopted
(Article 1.2)
Legacy Devices
• MDD NB issued CE marking certificates
• Class I SC MDD, upclassified MDR
(Corrigendum 2)
Categories of Devices
Current DOA
Article
120(2)
26 May 2021
---------
---------
3 June 2020
Article 120 Transitional
provisions “legacy”
26 May 2024
---------

8. II. Documentation Prioritization related
to Regulatory Strategy and Clinical
Strategy + Gap Analysis + Business
Portfolio

9. • Legacy devices: significant change in design
and intended purpose
• Legacy devices: significant change in state
of the art (MDD, Annex I, Section 2)
• NB capability
• designated to MDR
• ceases activity
• based in UK, Switzerland or Turkey
• capacity
• NB issued MDR certificates
expected to peak after August
2023 until May 2024
• Best period for NB MDR
certificate 2021 and 2022
Regulatory Strategy
Article
120(2)
26 May 2024
---------
“sell off” provision
26 May 2025
---------

10. • Sufficient clinical evidence
• Legacy devices or new devices
• Implantable and Class III
• Equivalence
Clinical Strategy

11. • Based on MDR Gap Analysis and
MDR Quality Plan
• Specific areas require
remediation
• Based on Business Portfolio
• Medical device family revenue
• Interest in medical device
family/ potential interest
Gap Analysis + Business Portfolio

12. III. PMS (Chapter VII, Annex III)

13. • Explicit requirement for legacy devices on
DoA (Article 120(3))
• Linked to RM to understand any residual
risks or assumptions that are part of the
RM process, benefit risk determination
• All manufacturers must perform PMS.
• PMS requires manufacturers to cooperate
with their distributors and importers.
• QSP PMS and Vigilance, PMS templates: PMS
Plan, PMS Report, and PSUR
Post-Market Surveillance (PMS) and
Risk Management (RM) and PMS
reporting
Definition of PMS (Article 2(60))
“all activities carried out by
manufacturers in cooperation
with other economic operators
to institute and keep up to date
a systematic procedure to
proactively collect and review
experience gained from devices
they place on the market, make
available on the market or put
into service for the purpose of
identifying any need to
immediately apply any
necessary corrective or
preventive actions”.

14. Article 83(3)
PMS System
a) to update the benefit-risk determination and to improve the risk management…
b) to update the design and manufacturing information, the IFU and the labelling
c) to update the clinical evaluation*
d) to update the summary of safety and clinical performance …
e) the identification of needs for CAPA or FSCA
f) the identification of options to improve the usability, performance and safety …
g) to contribute to the post-market surveillance of other devices and
h) to detect and report trends” (Article 88 – “Trend Reporting”)
The clinical evaluation and its documentation shall be updated throughout
the life cycle of the device concerned with clinical data obtained from the
implementation of the manufacturer’s PMCF plan ….
Article 61(11)

15. Manufacturers must have a PMS plan (Annex III, 1.1),
which addresses:
• Any specific questions related to safety, performance, risk-
benefit;
• Potential sources of information and how to access these;
• Product characteristics relevant for PMS;
• A proactive and systematic process to collect any
information;
• Tools to investigate incidents and complaints +
communication plans in case of serious risks;
• Effective and appropriate methods and processes to assess
the collected data;
• Suitable indicators and threshold values …. in the continuous
reassessment of the benefit risk analysis….;
• PMCF plan or a justification why this is not needed.
PMS Plan

16. The PMS Report and PSUR will summarize the
results and conclusions from PMS data, including
the rationale and description of any preventive
and corrective actions taken.
The PSUR will also contain:
a) the conclusions of the benefit-risk
determination;
b) the main findings of the PMCF;
c) the volume of sales of the devices and an
estimate of the size and other characteristics
of the population using the device and,
where practicable, the usage frequency of
the device.
PMS Reporting
• The PMS Report will be updated
when necessary for Class I and
made available to the CA upon
request.
• The PSUR must be updated yearly
for Class IIb and Class III and once
every two years for Class IIa.

17. • Reduced timeline for reporting all other
Serious Incidents (15 days vs. 30 days)
• Emphasis on Trend Reporting
• New definitions: recall, withdrawal, incident,
serious Incident (MDR Art.2(62-69))
• Reporting via EUDAMED (once functional)
• New MIR form introduced and its use is
mandatory (for both MDD and MDR
compliance)
These changes will require an update of your
vigilance SOP within your QMS.
Vigilance Reporting

18. Relationship
of PMS with
TD

19. IV. Technical Documentation (Annex II)
GSPR Checklist, MDR TDF, CER

20. Manufacturers must
meet the GSPRs listed in
Annex I MDR.
Currently most manufacturers
have included within their
Technical File/Design Dossier, an
ER Checklist. The GSPR Checklist
replaces the MDD ER Checklist.
General Safety and Performance Requirements (GSPR) Checklist
GSPR Checklist Example
Column 1 Column 2 Column 3 Column 4 Column 5
GSPR Comply (Y/N/NA)
Applied
Standards/ CS
Complying
Documents
Location
2.”… reduce risks
as far as possible
means the
reduction of risks
as far as possible
without
adversely
affecting the
benefit-risk
ratio…”
Y
EN ISO
14971:2012/ EN
ISO 14971/2019
Risk Management
Report,
Document
Control Number
Appendix F
Technical
Documentation
File
Typically, this GSPR Checklist includes the following columns:

21. The manufacturer reviews each GSPR [Column 1] and determines if it is necessary for the device to comply [Column
2] with that particular GSPR/ characteristic. If “NA” is the appropriate response, the manufacturer should include a
justification as to why the particular GSPR is not relevant.
If the GSPR were applicable, Column 2 should state “Y”. (If the GSPR is applicable though the manufacturer does
not yet comply, Column 2 would state “N”.).
In Column 3, the manufacturer would identify the standards or specifications which may be relevant. If a
manufacturer’s device is compliant to a standard which is European Norm harmonized and published in the Official
Journal of European Union (OJEU) to the MDR directive, the device is presumed to be compliant to the relevant
GSPR (Article 8). Similarly, if the manufacturer is compliant to Common Specifications (CS), the device is presumed
to be compliant to the relevant GSPR (Article 9).
GSPR Checklist, continued

22. MDR TDF
• Review existing MDD TF/DD
• Use Annex II as the basis as well as Notified
Body guidance
• Ensure there is sufficient information
• Recommend narrative text and use of
tables
• Consistency in content between different
regulatory documents

23. MDR TDF
The final finished
product is a PDF
that is hyperlinked,
bookmarked and the
“living” version can
be maintained in
RAMS Smart
Builder.

24. Project Initialization and the Syncing Tab
• The European Union Smart Builders have been
designed so that users can link Smart Builder
projects for the same Product through the Syncing
Tab.
• Additionally, this will ensure consistency between
projects for the same Product, automatically creating
identical product features (i.e., product descriptions,
test results, and manufacturing details) across all
Smart Builder projects for the same Product.

25. Template Text
• There is extensive template text
built into the project which
minimizes the effort required on
the part of the users, and
reduces errors.
• Some nodes require very little
input, for example, Node 4 –
Information Supplied by the
Manufacturer. The standards in
this node will autopopulate for
the user, so all they need to do
is confirm they are accurate,
and the node is complete.

26. Logic and Template Text
• In order to streamline the compilation process
and reduce errors, there is logic built into many
of questions within the MDR TD File Builder
that will enable or disable related questions
based on responses provided.

27. • Review existing MDD CER and MEDDEV
2.7/1, Rev. 4 and MDCG guidance
documents
• Align the Clinical Evaluation Plan (CEP) with
the CER
• Consistency in content between different
regulatory documents: labeling, Risk
Management, and clinical data (clinical
investigational data, published literature,
PMS data, and publicly available vigilance
data)
• Importance of similar devices and
equivalent devices and state of the art
Clinical Evaluation Report (CER)
Article 61 and Annex XIV
Definitions in EN ISO
14971:2019 State of the art

28. V. Recommendations

29. • Symbols
• Monitor and be aware of Standards
• Guidance
Recommendations

30. • Use of harmonized standards mentioned in
Article 8 and 9 and also in the GSPRs Annex
I, section 23.1(h) require, where
appropriate, the information supplied by
the manufacturer:
• EN ISO 15223-1 (standard currently under
revision) to add new symbols to comply
with the MDR, 21 New symbols: MD, EOs,
Sterile Barrier Systems, safe use symbols,
etc.
Symbols
“shall take the form of
internationally recognised symbols.
Any symbol or identification colour
used shall conform to the
harmonised standards or CS. In
areas for which no harmonised
standards or CS exist, the symbols
and colours shall be described in the
documentation supplied with the
device.”

31. • ISO/FDIS 20417 titled Medical devices — Information
to be supplied by the manufacturer is under
development in the review phase
• Will replace EN 1041:2008+A1:2013
• Developed after review of IMDRF guidance documents,
ISO 16142-1:2016, and GSPR of the MDR and IVDR
• Scope is information on the label, on the packaging, in
the IFU and technical description, required to be
provided with the device
New Standard to Replace EN 1041:2008

32. VI.Conclusion

33. • No certification is certain, unless
already MDR certified
• Even if current certificates under the
Directives remain, start implementing
MDR as much as possible now
• This helps develop practice and is
needed in case early transition is
needed
• Understand the concepts needed for
Eudamed and UDI, and implement if
necessary
Conclusion
Prioritization still = all the MDR
compliant documents prepared at
the time of MDR compliance

34. Thank You for your Time.
Continue to stay safe and well!
QUESTIONS?
Questions can be directed to
Evangeline.Loh@ul.com

35. References
1. https://ec.europa.eu/growth/sectors/medical-
devices/new-regulations/guidance_en
2. https://ec.europa.eu/docsroom/documents/40341
3. https://www.camd-europe.eu/wp-
content/uploads/2018/05/FAQ_MDR_180117_V1.0-
1.pdf
4.https://www.iso.org/obp/ui/#iso:std:iso:20417:dis:e
d-1:v1:en