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REGULATORY AND
LEGAL ASPECTS OF
3D PRINTING AND
BIOFABRICATION
Utrecht Summer School Course
14 July 2015
Sofie van der Meu...
Yesterday…
Superstars… & superheroes
Agenda
• How does the law see 3D printing?
• Intellectual property
• Personal data
Is it all that revolutionary?
Dental has been
doing this for ages
How the law sees 3D printing +
biofabrication
You use a production facility
• Medical devices and medicinal products produ...
How the law sees 3D printing
You apply a production process that can be regulated
• Manufacturing processes for medicinal ...
Regulation of the printer
Currently: EU
Machinery
Directive
Regulation of the material
• REACH (chemical substances)
• EU Tissues & Cells Directive (live cells and tissues)
Regulation of the material
• Intermediate material to be printed may constitute
medical device under current Commission gu...
Regulation of the end result
• Can be a medical device
Regulation of the end result
OR
• Can be an accessory to a medical device
• e.g. surgical guides
Regulation of the end result
• Can be an advanced therapy medicinal product
• OR a combination ATMP
Regulation of the end result
• Printing ‘old style’
medicinal products
Regulation of the end result
• Can be none of the foregoing,
e.g.
• pre-op models
• tissue models for research,
drug disco...
Regulation of the end result
Medical devices law
• Currently default regulatory position: custom-made
device
• Prescriptio...
Regulation of the end result
ATMP regulation
• Tissue engineered product
• May contain additional substances or objects, l...
Regulation of the end result
New Proposal on Medical Device Regulation
• increases standards for non custom-made 3D printe...
Regulation of the activity
• Quality system requirements / GMP requirements
Regulation of the activity
GMP requirements
• can turn out very cumbersome and unpractical for
bedside applications – ATMP...
Regulation of the activity
ATMP regulation currently subject
to revision; some careful optimism
warranted based on Commiss...
Regulation of the activity
Some notified bodies have started to request CE
marking as standalone software medical device o...
IP: Copyright - software
Protects the original form or expression of information but not the
underlying information itself...
IP: Patents
Patents
• Printing method (e.g. living cells)
• End result (ear with particular properties)
• Printing materia...
Intellectual property: body parts
Personal data
3d printing related activities involve collection and processing of
personal data concerning health and biom...
Personal data
Currently existing EU guidance relevant for 3D printing:
• personal data as concept
• WP 136 on concept of p...
New data protection regulation will
be regulatory nightmare for 3D
Different definitions for biometric data and data conce...
www.axonlawyers.com
THANKS FOR YOUR ATTENTION!
Sofie van der Meulen
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31...
Summer school Utrecht 3D printing and biofabrication
Summer school Utrecht 3D printing and biofabrication
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Summer school Utrecht 3D printing and biofabrication

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

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Summer school Utrecht 3D printing and biofabrication

  1. 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. 2. Yesterday…
  3. 3. Superstars… & superheroes
  4. 4. Agenda • How does the law see 3D printing? • Intellectual property • Personal data
  5. 5. Is it all that revolutionary? Dental has been doing this for ages
  6. 6. 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
  7. 7. 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
  8. 8. Regulation of the printer Currently: EU Machinery Directive
  9. 9. Regulation of the material • REACH (chemical substances) • EU Tissues & Cells Directive (live cells and tissues)
  10. 10. 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)
  11. 11. Regulation of the end result • Can be a medical device
  12. 12. Regulation of the end result OR • Can be an accessory to a medical device • e.g. surgical guides
  13. 13. Regulation of the end result • Can be an advanced therapy medicinal product • OR a combination ATMP
  14. 14. Regulation of the end result • Printing ‘old style’ medicinal products
  15. 15. Regulation of the end result • Can be none of the foregoing, e.g. • pre-op models • tissue models for research, drug discovery and toxicology.
  16. 16. 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?
  17. 17. 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
  18. 18. 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
  19. 19. Regulation of the activity • Quality system requirements / GMP requirements
  20. 20. 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
  21. 21. 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!
  22. 22. 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
  23. 23. 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)
  24. 24. IP: Patents Patents • Printing method (e.g. living cells) • End result (ear with particular properties) • Printing materials
  25. 25. Intellectual property: body parts
  26. 26. 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?
  27. 27. 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
  28. 28. 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”
  29. 29. 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 READ THIS BLOG: http://medicaldeviceslegal.com

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