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REGULATORY AND LEGAL ASPECTS OF 3D PRINTING AND BIOFABRICATION
Life Sciences & Health Cluster Café6 May 2015
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 + biofabricationYou use a production facility
• Medical devices and medicinal products production facilities are regulated (GMP, ISO 13485)
You make a product that can be regulated
• Medical device (or accessory), advanced therapy medicinal product or something else
You procure and use materials that can be regulated
• Parts for devices and substances for medicinal products are regulated; harvest, transport and use of biologic (tissues, cells) material is regulated
How the law sees 3D printing
You apply a production process that can be regulated
• Manufacturing processes for medicinal products and medical devices require a quality system
• NCAs / notified bodies may perceive design/production tools as medical devices (e.g. design software)
You provide a service that may be regulated
• Customer consulting re products and/or) production process (implementation, in-production finetuning of end result)
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 (live cells and tissues)
Regulation of the material
• Intermediate material to be printed from may constitute medical device under current Commission guidance for custom made devices
• Special regime for medical devices manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue (e.g. proteins)
Regulation of the end result
• Can be a medical device
• Can be an accessory to a medical device
• e.g. surgical guides
Regulation of the end result
• Can be an advanced therapy medicinal product
• Combination ATMP:
Regulation of the end result
• Printing ‘old style’ medicinal products
Regulation of the end result
• Can be none of the foregoing, e.g.
• pre-op models• tissue models for research, drug
discovery and toxicology
Regulation of the end result
Medical devices law
• Currently default regulatory position: custom-made device
• Prescription defines end result but production technique is standardised
• Question: what is “custom” about a 3D printed medical device?
Regulation of the end result
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• Placed on the market / industrial process?
Regulation of the end result
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
• Parliament proposal to exclude mass produced customised devices from scope of custom made devices
• No provision in new Regulation for•
• 3D printing• biofabrication
Regulation of the activity
• Quality system requirements / GMP requirements
Regulation of the activity
GMP requirements
• can turn out very cumbersome and unpractical for bedside applications – ATMP GMP requirements are geared towards development this at all (assumed to take place in industrial process in a fixed “facility”)
• NCAs generally risk averse and exhibit ‘department of no’ mentality and diverge in their assessments
• innovative companies get stuck in compromise solutions like hospital exemption under ATMP regulation
• no basis for viable business model• no basis for applied technological innovation
Regulation of the activity
ATMP regulation currently scheduled for revision; some careful optimism warranted based on Commission findings regarding
• autologous ATMPs• combined ATMPs
Yes, please!
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 and biometric data on many levels
• Data from hospital’s electronic health records• Generation of patient related data for end product• Data in files describing the final 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. modeling / printing?
Personal data
Currently existing EU guidance relevant for 3D printing
• personal data as concept
• WP 136 on concept of personal data• WP 192 on facial recognition
• personal data concerning health
• WP 131 on the processing of personal data relating to health in electronic health records (EHR)
• WP 189 on eHealth and privacy in epSOS
• biometric data
• WP 80 working document on biometrics• WP 193 on biometric data
New data protection regulation will be regulatory nightmare for 3DDifferent definitions for biometric data and data concerning health
In 3D printing definitely overlaps between these, but different requirements in regulation (biometric data not subject to health data processing exemptions in article 81 and 83) – problematic because also a ‘special category’ (prohibited unless)
should have said: “is collected for the purpose of”
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 [email protected] @meddevlegalB http://medicaldeviceslegal.com
READ MY BLOG:http://medicaldeviceslegal.com
