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3d printing and biofabrication

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Presentation at the UMCU Summerschool for Biofabrication and 3d printing about legal and regulatory aspects

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3d printing and biofabrication

  1. 1. REGULATORY AND LEGAL ASPECTS OF 3D PRINTING Utrecht Summer School Course: Biofabrication 16 July 2014 Erik Vollebregt www.axonadvocaten.nl
  2. 2. Agenda • How does the law see 3D printing? • Regulation of various aspects of 3D printing • Intellectual property • Personal data
  3. 3. How the law sees 3d printing You use a production facility • Medical devices and medicial products production facilities are regulated (GMP, ISO 13485) You make something that can be regulated • Medical device, advanced therapy medicinal product You use materials that can be regulated • Parts for devices and substances for medicinal products are regulated; harvest, transport and use of biologic material is regulated You apply a process that can be regulated • Manufacturing processes for medicinal products and devices require a quality system
  4. 4. How the law sees 3d printing You use data that pertain to an identified or identifiable person • Collection and processing of personal data concerning health • Customisation links objects to persons • Data can be breached, stolen etc
  5. 5. Regulation of the printer Currently: EU Machinery Directive
  6. 6. Regulation of the material • REACH (chemical substances) • EU Tissues & Cells Directive (cells and tissues)
  7. 7. Regulation of the end result • Can be a medical device • Can be an advanced therapy medicinal product
  8. 8. Regulation of the end result Medical devices law • Currently custom-made device • Prescription defines end result but production technique is standardised • Question: what is “custom” about a 3D printed medical device? 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
  9. 9. Regulation of the end result The 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.
  10. 10. Regulation of the activity • Quality system requirements / GMP requirements
  11. 11. Intellectual property: general • Copyright • Software • Software model for device / bodypart • Patents • Printing method (e.g. living cells) • End result (ear with particular properties) • Printing materials • Contributory Patent infringement: - the individual operating the 3D printer, and - the designer of the CAD file/s.
  12. 12. Intellectual property: body parts
  13. 13. Personal data 3d printing related activities involve collection and processing of personal data concerning health on many levels • Data from hospital’s electronic health records • Generation of patient related data for end product • Data in files describing the end 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. modelling?
  14. 14. www.axonlawyers.com THANKS FOR YOUR ATTENTION Erik Vollebregt Axon Lawyers Piet Heinkade 183 1019 HC Amsterdam T +31 88 650 6500 F +31 88 650 6555 M +31 6 47 180 683 E erik.vollebregt@axonlawyers.com @meddevlegal B http://medicaldeviceslegal.com READ MY BLOG: http://medicaldeviceslegal.com

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