2022-09-05 Webinar - How To Build Compliant Technical Documentation Under MDR

Medidee Services © 2022
ISO 9001 & ISO 13485 1

Certified company
Introduction
Philippe Etter Dr. Lydie Moreau

Senior Partner Project Associate

ISO 9001 & ISO 13485 2
Certified company
Webinar’s content and objectives
• What are the additional requirements of MDR compared to previous

directives:
à requirements for all types of MD – a step by step approach

à requirements specific to some devices
• How to make sure you have a clear traceability thread within your TD
to demonstrate compliance to all GSPRs
ISO 9001 & ISO 13485 3

Certified company
Webinar set-up
• During the first 45 minutes of this webinar, we will not yet

address questions, but please post them all in the chat
• We will have some questions / quizzes for you, your

participation is key!
• During the last 15 minutes, we will address questions you

have posted previously
ISO 9001 & ISO 13485 4

Certified company
Interested in further training?
Look out for the logo below and follow the link in the chat box

ISO 9001 & ISO 13485 5
Certified company
Why is it urgent to submit your TD under MDR?
ISO 9001 & ISO 13485 6

Certified company
1. Q&A
At which stage of MDR transition are you?
a) I am about to submit my TD under MDR
b) I am still compiling MDR-compliant TD
c) I am about to start the process of compiling MDR-compliant TD
d) Other stage not mentioned above
ISO 9001 & ISO 13485 7

Certified company
All MD SaMD Implant D.D.
All Medical Devices
ISO 9001 & ISO 13485 8

Certified company
STEP 1 : Confirm your device classification
80% of SaMD are deemed to change classification!
Intended Use
Risk Profile
Class I Class I s/m/r Class IIa Class IIb Class III
Notified Body involved in conformity assessment!
No NB
Clinical evaluation consultation*
involved
* III and IIb active device intended to

administer and/or remove medicinal product
ISO 9001 & ISO 13485 9
Certified company
STEP 2 : Review GSPR to identify all applicable standards
MDR
Article 10.4
General obligations of manufacturers
“Manufacturers […] shall draw up and keep up to date technical
documentation […] to allow the conformity assessment of the device
with the requirements of this Regulation”
à TD must provide sufficient evidence for fulfilling the

General Safety And Performance Requirements
ISO 9001 & ISO 13485 10

Certified company
Correct hierarchy of “standards” used?
GSPR – Annex I Applicability? Justification if not applicable?
Req. ID Description Applicable Applied Standards Fulfilment of the requirements

CHAPTER I. General Requirements
1 Devices shall achieve the performance intended by their ISO 14971:2019 clause 5.2, Hazard Analysis Report
manufacturer and shall be designed and manufactured in such a 8 Risk Management Report
way that, during normal conditions of use, they are suitable for their IEC 62366-1:2014 clause 4.1 System Verification Report
intended purpose. They shall be safe and effective and shall not ISO 10993-1:2018 clause Clinical Evaluation Report
compromise the clinical condition or the safety of patients, or the 4.1, 4.2, 7
Yes EN 60601-1 Test Report
safety and health of users or, where applicable, other persons,
ISO 11607-1:2019 clause EN 60601-1-2 Test Report
provided that any risks which may be associated with their use
5.1, 5.3, 5.5, 6.1, 8
constitute acceptable risks when weighed against the benefits to
the patient and are compatible with a high level of protection of ISO 11607-2:2019 clause 5
health and safety, taking into account the generally acknowledged MEDDEV 2.7/1 rev4
state of the art.
2 The requirement in this Annex to reduce risks as far as possible ISO 14971:2019 clause 7.5 Risk Management File
means the reduction of risks as far as possible without adversely ISO 10993-1: 2018 clause Biological Evaluation Report
affecting the benefit-risk ratio. Yes 4.1, 4.3, 4.5, 4.7, 4.8, 7 Usability Engineering File
IEC 62366-1:2014 clause
5.1-9
… …
11.3 Devices labelled as sterile shall be processed, manufactured, ISO 11607-1:2019 clause Risk Management File
packaged and, sterilized by means of appropriate, validated 5.2, 6.1 Manufacturing Work Instructions
methods. Yes ISO 15223-1:2021 clause Label
5.2.8 Verification & validation test
reports

ISO 9001 & ISO 13485 11
Certified company
STEP 2 : Review GSPR to identify all applicable standards
Remember: NO GRAND-FATHERING
à Your NB will review the TD as if it was the 1st time

à Having plenty of rationales why “new versions of the standards do
not impact old tests performed” might not work anymore…
Rationale 1
Rationale 2
Rationale 3
ISO 9001 & ISO 13485 12
Certified company
2. Q&A
Can harmonized standards under MDD be

applied to show conformity under MDR?
a) Yes, harmonized standards under MDD can be applied but state

of the art needs to be considered and argued
b) Yes, harmonized standards under MDD can be applied to show

conformity with GSPRs from MDR
c) No, they cannot be applied
ISO 9001 & ISO 13485 13

Certified company
Pitfalls to avoid!
• The Legal Manufacturer claims conformity to ISO xyz:2016 while the tests
reports demonstrate conformity with ISO xyz:2007.
• Test report referenced in section xyz of the GSPR does not relate to the
device submitted (copy / paste mistake)
• All reports mentioned in the V&V matrix / GSPR checklist cannot be

located in the TD

ISO 9001 & ISO 13485 14
Certified company
STEP 3 : Review you TD organization (Annexes II & III, MDR)

Ensure information traceability
Provide Medidee
Tech-Doc
Servicesstructure
© 2022 according Annex II and III if EU
ISO 9001 & ISO 13485 15
Certified company
only (check first with NB if you want to use IMDRF ToC)
STEP 3 : Review you TD organization (Annexes II & III, MDR)

Ensure information traceability
Functional
User Requirement
Requirement Risk Analysis Clinical Evaluation
Specification
Specification
URS 01 FRS 01.01 RA 01.01.01

FRS 01.02 CL 01.01.01.01
URS 02 RA 01.01.02
… … RA 01.01.03
FRS 01.19 …
GSPR 1
GSPR 2
FRS 02.01 V&V …
FRS 02.02
GSPR 13.6
“Traceability Matrix” …
…
FRS 02.08 Report X.1
Report X.2
ISO 9001 & ISO 13485 16
Certified company
STEP 4 : Project planning
1st :
Start outsourced work to
avoid bottlenecks
GAP ANALYSIS (for example lab tests,
CER…)
List of documents / tests /
validations (…) that need to
be updated or created
2nd :
Update time consuming
key documents (step 5)
(for example RM file)
ISO 9001 & ISO 13485 17
Certified company
STEP 5 : Update key documents under MDR

Risk management file
Risk Analysis
User Level – aFMEA / uFMEA
Application
Analysis Evaluation Control
or Use
Analysis
Component / Function Level – dFMEA
Design Analysis Evaluation Control
Analysis
Process Level – pFMEA
Manufacturing Analysis Evaluation Control

Analysis
ISO 9001 & ISO 13485 18
Certified company

Clinical Evaluation Plan and Report
Intended clinical Benefit - Risk

benefit justification
SOTA assessment Clinical evidence:

available clinical data
Risks
Benefits
=> Define relevant clinical performance & safety

indicators
=> Set acceptance criteria
ISO 9001 & ISO 13485 19

Certified company
3. Q&A
Which of the below statements is correct?
a) Class I medical devices do not need a clinical evaluation nor a

clinical investigation
b) Manufacturers of medical devices, independent of the risk class,

will need to conduct a clinical investigation for each medical device
c) Manufacturers of medical devices, independent of the risk class,

will need to conduct a clinical evaluation for each medical device.
ISO 9001 & ISO 13485 20

Certified company

PMS File
PLANNING EXECUTION REPORTING
PMCF PMCF
plan report
BENEFIT-RISK?
CEP CER SSCP NoBo
PSUR / NoBo
PMS PMS
plan report
ISO 9001 & ISO 13485 21
Certified company

Usability engineering file
• The intended use
• The users
• The use environment
Result of the usability engineering

• The user interface process throughout the D&D +
inputs of RM file
ISO 9001 & ISO 13485 22

Certified company
STEP 6 : Do not neglect QMS alignment

• PRRC and its responsibilities related to technical
documentation
• Vigilance and the related processes (adverse event

reporting, trend reporting, periodic summary process, SSCP
if applicable)
• Device traceability (UDI numbering system)
• Eudamed registration, data accuracy, EC-Rep (if applicable)
ISO 9001 & ISO 13485 23

Certified company
Software as a
Medical Device
(SaMD)

ISO 9001 & ISO 13485 24
Certified company
Standalone software: frequent gaps in TD
à V&V gaps during the D&D phases

(needed at each software level:
plan with acceptance criteria à reports)
à No cybersecurity data
à No usability data

ISO 9001 & ISO 13485 25
Certified company
Standalone software: frequent gaps in TD
à Risk management file not covering all

aspects of the software (design / use stages)
à CER without good clinical records
àNo summary of all tests performed in the

V&V section (together with all tests)

ISO 9001 & ISO 13485 26
Certified company
Implantable
Medical Devices

ISO 9001 & ISO 13485 27
Certified company
MDR transition –> Review clinical strategy

NB:
Obligation to consult Expert panels for clinical evaluation Art 54
Manufacturer:
Option to consult expert panels prior to clinical evaluation and / or
investigation Art 61 (2)
For :
• Class III implantable devices
• Class IIb active devices intended to administer and / or remove a
medicinal product
ISO 9001 & ISO 13485 28
Certified company
Active implantable accessories = Class III
Rule 8: accessories of active implantable are also

classified as Class III medical devices
àException compared to other devices

àAll MDR requirements then apply to those
accessories, need all V&V data

ISO 9001 & ISO 13485 29
Certified company
Combination Products
(Drug Delivery Products)

ISO 9001 & ISO 13485 30
Certified company
Device part à requirements now apply

(when the drug is key for the combination product)
If device part not CE marked:

àNeed a TD regarding the device part
àThe NB needs to give its opinion on the device part
EMA (European Medicines Agency) will then check the file to ensure
everything is covered
àPharmaceutical companies might have to deal with NB for the 1st time

ISO 9001 & ISO 13485 31
Certified company
Key messages to take home
• Put yourself in the position of the reviewers and take into account
the review process at your NB!
• Indicate clearly where to find the evidence (not “Risk Management
Report” but “RM Report, section 3”)
• Ensure traceability between Specs, Risk Analysis, CER, GSPR à the
V&V matrix is key
• If you deliver TD as pdf, use hyperlinks, prepare native searchable
pdf, use consistent wording
• Make meaningful summaries for each section (STED) – with links to
the further evidence

ISO 9001 & ISO 13485 32
Certified company
Guidance Technical
Documentation MDR:
à Being updated

ISO 9001 & ISO 13485 33
Certified company
Info & Registration:
training@medidee.com
34
ISO 9001 & ISO 13485
Certified company
Medidee’s services
Digital Health
Switzerland | Germany | Denmark | Spain | Belgium | APAC | USA
www.medidee.com
ISO 9001 & ISO 13485 35

Certified company
Thank you for your attention!
Time for questions from the chat
ISO 9001 & ISO 13485 36

Certified company

2022-09-05 Webinar - How To Build Compliant Technical Documentation Under MDR

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2022-09-05 Webinar - How To Build Compliant Technical Documentation Under MDR

Uploaded by

Copyright:

Available Formats

Medidee Services © 2022

ISO 9001 & ISO 13485 1

Philippe Etter Dr. Lydie Moreau

Medidee Services © 2022

• What are the additional requirements of MDR compared to previous

à requirements for all types of MD – a step by step approach

ISO 9001 & ISO 13485 3

• During the first 45 minutes of this webinar, we will not yet

• We will have some questions / quizzes for you, your

• During the last 15 minutes, we will address questions you

ISO 9001 & ISO 13485 4

Medidee Services © 2022

ISO 9001 & ISO 13485 6

At which stage of MDR transition are you?

a) I am about to submit my TD under MDR

b) I am still compiling MDR-compliant TD

c) I am about to start the process of compiling MDR-compliant TD

d) Other stage not mentioned above

ISO 9001 & ISO 13485 7

All Medical Devices

ISO 9001 & ISO 13485 8

STEP 1 : Confirm your device classification

80% of SaMD are deemed to change classification!

Class I Class I s/m/r Class IIa Class IIb Class III

Notified Body involved in conformity assessment!

* III and IIb active device intended to

STEP 2 : Review GSPR to identify all applicable standards

à TD must provide sufficient evidence for fulfilling the

ISO 9001 & ISO 13485 10

GSPR – Annex I Applicability? Justification if not applicable?

Req. ID Description Applicable Applied Standards Fulfilment of the requirements

Medidee Services © 2022

STEP 2 : Review GSPR to identify all applicable standards

à Your NB will review the TD as if it was the 1st time

Can harmonized standards under MDD be

a) Yes, harmonized standards under MDD can be applied but state

b) Yes, harmonized standards under MDD can be applied to show

c) No, they cannot be applied

ISO 9001 & ISO 13485 13

• All reports mentioned in the V&V matrix / GSPR checklist cannot be

Medidee Services © 2022

STEP 3 : Review you TD organization (Annexes II & III, MDR)

STEP 3 : Review you TD organization (Annexes II & III, MDR)

URS 01 FRS 01.01 RA 01.01.01

STEP 4 : Project planning

STEP 5 : Update key documents under MDR

Manufacturing Analysis Evaluation Control

STEP 5 : Update key documents under MDR

Intended clinical Benefit - Risk

SOTA assessment Clinical evidence:

=> Define relevant clinical performance & safety

ISO 9001 & ISO 13485 19

Which of the below statements is correct?

a) Class I medical devices do not need a clinical evaluation nor a

b) Manufacturers of medical devices, independent of the risk class,

c) Manufacturers of medical devices, independent of the risk class,

ISO 9001 & ISO 13485 20

STEP 5 : Update key documents under MDR

STEP 5 : Update key documents under MDR

• The intended use

• The use environment

Result of the usability engineering

ISO 9001 & ISO 13485 22