The document discusses the regulatory and legal aspects of 3D printing, focusing on its application in biofabrication, particularly for medical devices. It covers how the law views production facilities, materials, and processes involved, as well as implications for intellectual property and personal data management. Additionally, it emphasizes stricter regulations proposed for non-custom-made 3D printed medical devices, including quality system requirements and the handling of personal health data.

1. REGULATORY AND
LEGAL ASPECTS OF
3D PRINTING
Utrecht Summer School Course:
Biofabrication
16 July 2014
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• How does the law see 3D printing?
• Regulation of various aspects of 3D printing
• Intellectual property
• Personal data

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. 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. Regulation of the printer
Currently: EU
Machinery
Directive

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

7. Regulation of the end result
• Can be a medical device
• Can be an advanced therapy medicinal product

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

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. Intellectual property: body parts

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. 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