We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

1. Simon Wieser
Global Medtech Regulatory Trends
True Quality Summit Series
Reducing friction
between companies
and regulatory bodies
THE NEXT LEVEL.
TOGETHER.

2. Simon Wieser
▪ Auditor for MDR, MDSAP and ISO 13485
▪ Background in Physics
▪ Experience as R&D Engineer for >6 years at an AIMD manufacturer
▪ with TÜV SÜD since 2019
Contact: Simon.Wieser@tuvsud.com
LinkedIn: https://www.linkedin.com/in/simon-wieser/
Presenter
2
TÜV SÜD Product Service GmbH | Reducing Friction between Companies and Regulatory Bodies

3. Agenda
A peek behind the curtain of a notified body
2
The MD-codes
3
Take home message
4
The current environment
1

4. ▪ Treasure: Successful transfer from MDD to MDR before May 2024
▪ Volatile, uncertain, complex environment
▪ Rumours/wishes: postponement of deadline May 2024
▪ POLITICALLY NOT POSSIBLE
▪ Result: rising tension between authorities, NBs and
manufacturers while close cooperation is needed to
‘find the treasure’
The ‘treasure hunt’ for MDR implementation
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TÜV SÜD Product Service GmbH | Reducing Friction between Companies and Regulatory Bodies
5
Guidance
EUDAMED
NB-
capacity
MDR
implement.
TÜV
SÜD

5. Notified Body -
Resource bottleneck
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6. Resources
- Notified bodies hired >2,000 employees in the past 5 years

7. Resources
2010 – 2021 Full Time Equivalent Employees in Notified Bodies
0
500
1000
1500
2000
2500
3000
3500
4000
4500
2021
2020
2019
2018
2017
2016
2015
2014
2013
2012
2010
Direct Employees Externals
2.25x fold in 5 years
External personal constant
Take home message

8. Times
- Initial MDR assessments
43
53
4
> 12 Months
< 6 Months
6-12 Months

9. How to handle this environment? What does it mean for you?
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10. How to handle this environment? What does it mean for you?
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11. Plan ahead
How to handle this environment? What does it mean for you?
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Communicate early
Plan enough buffer time

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TÜV SÜD Product Service GmbH | Reducing Friction between Companies and Regulatory Bodies
A peek behind the curtain of a NB

13. ▪ The Product Specialist → for TD assessment and change notifications related to the device
▪ The Auditor → for audit planning and change notifications related to the QMS
▪ The Project Coordinator / Assistant → for project timelines, quotes and administrative topics
And (best case scenario):
▪ Central Contact Point: Client manager → Distributes client requests to appropriate contact point and gathers all
information as a central knowledge point.
Your main contact point(s)
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Know your contact point

14. How is a notified body structured?
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Client
NB Review Teams
Product Specialists
Auditors
Technical Reviewer
Project Coordinators
Assistants
Will plan and handle the
audit/TD project
Certification
Board
Additional
Review by
„Certifier“
Independent
from the NB
review teams
National
Competent
Authority
Audits the
NB and
also pulls
technical
files
Notified Body

15. Application
Technical
Documentation
Audit
Clarification
Certificate

16. Client
Application for
TD Review and
Submission of
TD
Product
Specialist
Review of
application and
project
planning
Assistant
Send quotation
Book reviewers
Plan timeline
Certification
Board
Review of
project
planning and
approval of
project
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Application Phase

17. Product
Specialists
Review of all
aspects of TD
Creation of
assessment
reports
Deficiency
Rounds with
client
Technical
Reviewer
Review of all
assessment
reports
Additional
Certification
Board
Certification
reviewer
performs an
additional
review of the
whole
assessment
file
Product
Specialist
Provides
Answers to
the
certification
reviewer
Certification
Board
Final Release
of project
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Depending on the device and risk level, there
will be multiple different reviewers/reports
TD Assessment

18. Takeaway
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Planning phase is crucial
Even at later stages,
clarifications might be necessary

19. Auditor/Client
Auditor:
Gather
information &
Audit planning
Client:
Control of
audit plan and
feedback
Certification
Board
Release audit
Auditor
/
Client
Perform audit
Auditor
/
Client
Audit Follow-
up
(Non-
conformities)
Report
Certification
Board
Review of
audit file
Issue
certificate
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Audit

20. Takeaway
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Discuss changes and scope
expansions before the audit
Carefully review audit plan

21. Short Intro to MD-codes (and why they matter)
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22. Certificates / Codes / Metadata
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EMDN Code
Metadata is not
visible on Cert
but just as
important!

23. ▪ Important for the manufacturer: EMDN Code
– This code will be listed on the QM certificate
▪ Important for the notified body: MD-Codes
The Codes – What do they mean and what are they used for?
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Related to the device:
Exactly 1 MDA/MDN code
Related to the technology: All
applicable MDT/MDS codes

24. ▪ The MDA/MDN/MDS/MDT codes decide who within the notified body is qualified to review a specific device / perform an
audit at a specific facility.
▪ E.g.: For the assessment of an active implantable medical device the product specialist, the technical reviewer and the
certification reviewer all have to be trained and qualified under the code MDA0101.
The Codes – What do they mean and what are they used for?
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Clarify which codes are applicable to
you and your devices

25. Example – MDN Code
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▪ Excerpt of a notified body designation form. (not TÜV SÜD)

26. Example MDT-Code
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27. ▪ If you are not sure: Discuss early which codes are applicable to your devices with your NB
▪ For a new device a QM scope expansion might be needed additionally to the TD assessment.
▪ If you plan to change something regarding your manufacturing technologies or special processes (e.g. sterilization method
from ETO to gamma radiation), let your NB know as early as possible to allow planning of required assessment steps.
The Codes – What do they mean and what are they used for?
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MD-codes can have influence on
project timeline
Additional devices might lead to
additional audit activities

28. Agenda
A peek behind the curtain of a notified body
2
The MD-codes
3
Take home message
4
The current environment
1

29. Testing at 17025 accredited test labs
30
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TÜV SÜD Product Service GmbH | Reducing Friction between Companies and Regulatory Bodies
Microbiological
Testing
Biocompatibility
Testing
Environmental
& Packaging
Testing
Rehabilitation,
Medical Care
and Physical
Therapy
Cyber Security
Testing
Chemical
Characterization
Electrical
Safety Testing
Battery
Testing
Certification
and
Global Market
Access
Radio
Equipment –
Testing and
Global Market
Access
Electromagnetic
Compatibility
Testing
Functional
Safety Testing
MRI Safety
& MRI
Compatibility
Testing

30. Do you know our one-
stop shop for testing?
TÜV SÜD AG
Westendstr. 199
80686 Munich
Germany
medicaldevicetesting@tuvsud.com
www.tuvsud.com/mhs-testing
Chemical Characterisation
Toxicological Risk Assessment
ISO 10993-18, ISO 10993-17
Biocompatibility ISO 10993 series
Microbiological Testing ISO 11137, ISO 11737, ISO 17664
Environmental Simulation IEC 60721, IEC 60529, UL50/UL50E, IEC 60068
Transportation
Simulation & Packaging
ISO 11607-1, ISTA series, ASTM series, ASTM F1980
Rehabilitation, Medical Care &
Physical Therapy
EN 12183, ISO 7176-ff, EN 12184, ISO 7176-ff, EN 50637, EN ISO 10535, EN 12182, ISO 17966,
EN 1985, EN ISO 11199, IEC 80601-2-78, EN 20957-ff, EN 957-ff
Electrical Safety
IEC 60601 series, IEC 61010 series, IEC 60825-1, IEC 62471, IEC 61508/ISO 13849, ANSI/AAMI
ES 60601-1:2005/(R)2012, CAN/CSA C22.2 NO. 60601-1:14, JIS T0601-1:2012 (IEC 60601-1:2005)
Battery Testing IEC 62133 series, UN 38.3
Functional Safety / Single Fault Safety IEC 60601-1
Electromagnetic Compatibility (EMC) IEC 60601-1-2, IEC 60601-2-x, IEC TR 60601-4-2, IEC 61326-1, ETSI EN 301 489-1, -3, -17
Radio Equipment – Testing & Global
Market Access
ETSI EN 300 328 series/ETSI EN 301 893 series, ETSI EN 300 220 series/ETSI EN 300 330 series,
ETSI EN 301 839 series/ETSI EN 303 203 series, ANSI C63.10 series/FCC Part 15 B/
FCC Part 15 C, RSS-Gen/RSS-210/RSS-247, Japan ARIB Standards/MIC Ordiances, RED/
FCC/RSS requirements, FDA Wireless Co-Existence Standard, IEEE ANSI C63.27-2017
MRI Safety Testing ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, ASTM F2503
Cyber Security Testing IEC 62443, IEC 62304
Note: All testing laboratories are ISO 17025 accredited and/or GLP compliant.

31. Which value do you
benefit from?
1 One stop shop for medical device testing
3 Competitive pricing due to global lab network
2 Dedicated project handler & Executive Summary
TÜV SÜD AG
Westendstr. 199
80686 Munich
Germany
medicaldevicetesting@tuvsud.com
www.tuvsud.com/mhs-testing

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Big challenge – Step by Step
Stay in contact and close communication with your NB.
Work as a team to overcome the hurdles in this fast changing and
uncertain environment.
Together, we enable market approval for safe and reliable medical
devices.

33. ▪ We are operating in a complex environment (which is still undergoing changes)
▪ A lack of regulatory/QM resources can be seen on both the NB and industry side
▪ To overcome these hurdles close collaboration and communication between companies and the notified body is necessary
Take Home Message
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35. Questions?
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36. ▪ Common issues during TD and Audit
Attachments
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37. 1. Technical Documentation not complete
2. Structure does not cover Annex II & III
3. Missing documents:
▪ Process data often incomplete
3. Content issues
▪ General Safety and Performance Requirements
▪ Documented evidence missing
▪ Information on design stages missing
▪ Information on pre-clinical testing not included
▪ Post market activities unclear and not described
TD Assessment

38. ▪ Relevant roles not defined
▪ EUDAMED not covered by QMS
▪ UDI System integration missing
▪ No awareness on Common Specifications
▪ No awareness on latest MDCG guidance documents
Audit

39. ▪ Internal audit on MDR implementation missing
▪ Internal auditors not qualified for MDR
▪ Post Market Surveillance requirements not fully implemented
▪ Article 120 not followed – appropriate surveillance
▪ Vigilance and interlink of processes not established
Audit