Legal and regulatory aspects of 3D printing and biofabrication. Lecture for Utrecht Summer School 14 July 2015.

1. REGULATORY AND
LEGAL ASPECTS OF
3D PRINTING AND
BIOFABRICATION
Utrecht Summer School Course
14 July 2015
Sofie van der Meulen
www.axonlawyers.com

2. Yesterday…

4. Superstars… & superheroes

5. Agenda
• How does the law see 3D printing?
• Intellectual property
• Personal data

6. Is it all that revolutionary?
Dental has been
doing this for ages

7. How the law sees 3D printing +
biofabrication
You use a production facility
• Medical devices and medicinal products production
facilities are regulated (GMP, ISO 13485)
You make a product that can be regulated
• Medical device (or accessory), advanced therapy
medicinal product or something else
You procure and use materials that can be regulated
• Parts for devices and substances for medicinal
products are regulated; harvest, transport and use of
biologic (tissues, cells) material is regulated

8. How the law sees 3D printing
You apply a production process that can be regulated
• Manufacturing processes for medicinal products and medical
devices require a quality system
• NCAs / notified bodies may perceive design/production tools as
medical devices (e.g. design software)
You use data that pertain to an identified or identifiable person
• Collection and processing of personal data concerning health
• Customization links objects to persons
• Data can be breached, stolen etc

9. Regulation of the printer
Currently: EU
Machinery
Directive

10. Regulation of the material
• REACH (chemical substances)
• EU Tissues & Cells Directive (live cells and tissues)

11. Regulation of the material
• Intermediate material to be printed may constitute
medical device under current Commission guidance
for custom made devices
• Special regime for medical devices manufactured
utilizing animal tissue which is rendered non-viable or
non-viable products derived from animal tissue (e.g.
proteins)

12. Regulation of the end result
• Can be a medical device

13. Regulation of the end result
OR
• Can be an accessory to a medical device
• e.g. surgical guides

14. Regulation of the end result
• Can be an advanced therapy medicinal product
• OR a combination ATMP

15. Regulation of the end result
• Printing ‘old style’
medicinal products

16. Regulation of the end result
• Can be none of the foregoing,
e.g.
• pre-op models
• tissue models for research,
drug discovery and
toxicology.

17. Regulation of the end result
Medical devices law
• Currently default regulatory position: custom-made
device
• Prescription defines end result but production
technique is standardized
• Question: what is “custom” about a 3D printed
medical device?

18. Regulation of the end result
ATMP regulation
• Tissue engineered product
• May contain additional substances or objects, like
scaffolds
• ATMP unless completely unviable
• Cells / tissues substantially manipulated
• Combined advanced therapy medicinal products

19. Regulation of the end result
New Proposal on Medical Device Regulation
• increases standards for non custom-made 3D printed
medical devices by introducing stricter identification
(UDI), traceability and registration requirements
• Parliament proposal to exclude mass produced
customized devices from scope of custom made
devices
• No provision in new Regulation for
• 3D printing
• biofabrication

20. Regulation of the activity
• Quality system requirements / GMP requirements

21. Regulation of the activity
GMP requirements
• can turn out very cumbersome and unpractical for
bedside applications – ATMP GMP requirements are
geared towards development this at all (assumed to
take place in industrial process in a fixed “facility”)
• NCAs generally risk averse and exhibit ‘department of
no’ mentality and diverge in their assessments
• innovative companies get stuck in compromise
solutions like hospital exemption under ATMP
regulation
• no basis for viable business model
• no basis for applied technological innovation

23. Regulation of the activity
ATMP regulation currently subject
to revision; some careful optimism
warranted based on Commission
findings regarding
• autologous ATMPs
• combined ATMPs
Yes, please!

24. Regulation of the activity
Some notified bodies have started to request CE
marking as standalone software medical device of
• final product design software
• customer requirements fine-tuning collaboration
software
IMHO unlawful approach – regulation of production tools
as medical devices that will be placed on the market

25. IP: Copyright - software
Protects the original form or expression of information but not the
underlying information itself. -> specific algorithm
• “original” only if “selection or arrangement of contents is
author’s own intellectual creation”.
• Infringement by translation or making an altered version.
Successful claim needs to show at least:
• That copyright exists (pragmatic approach ‘what is worth
copying is worth protection’)
• Claimant owns the copyright
• Work is within copyright (life plus 70 years for software
and databases)
• Infringement (substantial part is reproduced without
authorisation)

26. IP: Patents
Patents
• Printing method (e.g. living cells)
• End result (ear with particular properties)
• Printing materials

27. Intellectual property: body parts

28. Personal data
3d printing related activities involve collection and processing of
personal data concerning health and biometric data on many levels
• Data from hospital’s electronic health records
• Generation of patient related data for end product
• Data in files describing the final product
• etc.
Who controls the data?
• Controller has regulatory burden, must conclude processing
agreement with others that get access to the data
Where is the data?
• External printing lab?
• Hosted?
• Sent outside of EU for e.g. modeling / printing?

29. Personal data
Currently existing EU guidance relevant for 3D printing:
• personal data as concept
• WP 136 on concept of personal data
• WP 192 on facial recognition
• personal data concerning health
• WP 131 on the processing of personal data relating to
health in electronic health records (EHR)
• WP 189 on eHealth and privacy
• Letter of WP29 of 5 February 2015 on health data
• biometric data
• WP 80 working document on biometrics
• WP 193 on biometric data

30. New data protection regulation will
be regulatory nightmare for 3D
Different definitions for biometric data and data concerning health
In 3D printing definitely overlaps between these, but different requirements
in regulation (biometric data not subject to health data processing
exemptions in article 81 and 83) – problematic because also a ‘special
category’ (prohibited unless)
should have said: “is collected for the purpose of”

31. www.axonlawyers.com
THANKS FOR YOUR ATTENTION!
Sofie van der Meulen
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 53 44 05 67
E sofie.vandermeulen@axonlawyers.com
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