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

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