REGULATORY AND LEGAL ASPECTS OF 3D PRINTING

Utrecht Summer School Course: Biofabrication16 July 2014

Erik Vollebregtwww.axonadvocaten.nl

Agenda

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

How the law sees 3d printingYou 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

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

Regulation of the printerCurrently: EU Machinery Directive

Regulation of the material

• REACH (chemical substances)

• EU Tissues & Cells Directive (cells and tissues)

Regulation of the end result

• Can be a medical device

• Can be an advanced therapy medicinal product

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

Regulation of the end result

The new Proposal on Medical Device Regulationincreases standards for non custom-made 3D printed medical devices by introducing stricter identification (UDI), traceability and registration requirements.

Regulation of the activity

• Quality system requirements / GMP requirements

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.

Intellectual property: body parts

Personal data3d 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?

www.axonlawyers.com

THANKS FOR YOUR ATTENTION

Erik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E erik.vollebregt@axonlawyers.com @meddevlegalB http://medicaldeviceslegal.com

READ MY BLOG:http://medicaldeviceslegal.com