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 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

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 printer

Currently: 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 Regulation

increases 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 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

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