JRC Roundtable on additive manufacturing in medical devices JRC European Commission – Ispra – November 4th 2015

1. 3D PRINTING IN HEALTHCARE:
REGULATORY ISSUES IN THE
FUTURE OF MEDICINE
Avv. Maria Livia Rizzo, PhD
info@marialiviarizzo.com
marialiviarizzo.com
J R C R o u n d t a b l e o n a d d i t i v e m a n u f a c t u r i n g i n m e d i c a l d e v i c e s
J R C E u r o p e a n C o m m i s s i o n – I s p r a – N o v e m b e r 4 t h 2 0 1 5

2. Who I am
§ Lawyer
§ Law & Technology PhD
§ Research Fellow at CIRSFID – University of Bologna
§ Teaching Fellow at Forensic Medicine chair – Faculty of Law –
University of Bologna
§ Legal 3D Printing Co-Founder (legal3dprinting.it)

3. 3D PRINTING
Lack of regulation

4. 3D PRINTER
§ Directive 2006/42/
EC of the European
Parliament and of the
Council of 17 May
2006
§ Product liability:
manufacturer

5. 3D PRINTING IN MEDICINE
Involvement of:
§ printer manufacturer
§ 3D model designer
§ surgeon
§ other healthcare professionals
§ hospital
§ ethics committee
§ insurance company
§ maker

6. 3D PRINTING IN MEDICINE
ANATOMICAL MODELS
MEDICAL DEVICES
BIOPRINTING

7. ANATOMICAL MODELS
§ diagnostic tools
§ surgical planning
§ medical training
- medical students
- surgical trainees
§ patient education
- to obtain informed
consent
§ medical research

8. ANATOMICAL MODELS
Legal issues
§ Liability for deviating from
an existing standard of
care?
§ Are supportive tools or
medical devices?
Regulation?
§ Informed consent:
§ Negotiating responsibility
§ Redirecting the decision
making authority back to the
patient
§ Decrease of medicolegal
claims
§ Defective tools:
§ Harms to patient
§ Lack of oversight of the
quality

9. MEDICAL DEVICES
§ anyone can print a MD
§ anyone can upload and
download a MD blueprint
§ counterfeit devices
§ unsafe devices
§ defective devices
§ errors in customization settings
§ toxic materials
§ harms to patient
§ implants
§ prosteheses
§ braces
§ guides and templates
Risks

10. MEDICAL DEVICES
Current EU regulation
§ Council Directive 93/42/EEC of 14 June 1993
Custom-made medical devices
§ Any device specifically made in accordance with a duly qualified
medical practitioner’s written prescription which gives, under his
responsibility, specific design characteristics and is intended for
the sole use of a particular patient.
§ A manufacturer of a custom-made medical device, who places
devices on the European market under his own name, must meet
the requirements of national legislation, which transposes the
Medical Devices Directive 93/42/EEC (MDD)

11. MEDICAL DEVICES
Who is the manufacturer?
§ Custom-made manufacturer –
“The natural or legal person who
undertakes the design of the
product and manufactures the
device to a predefined specification
(i.e. a prescription)” (EU Guidance Note
for Manufacturers of Custom-made Medical
Devices)
§ 3D model designer?
§ 3D printer producer?
§ health professional?
§ maker?
Low regulatory burden
§ Custom-made devices shall not
be CE marked (article 17 MDD /
article 12 AIMDD)
§ New Proposal MDR:
Manufacturers of CMMD must
ensure that their devices are
safe and perform as intended
§ suitable for low risk traditional
devices
§ unsuitable for high risk 3D
printed medical devices

12. MEDICAL DEVICES
3D printed MD will be still custom-made devices?
§ mass-produced devices which need to be adapted to meet
the specific requirements of any professional user and
devices which are mass-produced by means of industrial
manufacturing processes in accordance with the written
prescriptions of any authorised person shall not be
considered to be custom-made devices (New Proposal MDR)
§ Exclusion of individualized 3D printed medical devices from
the field of CMMD?
§ How is 3D printing process to be deemed?

13. MEDICAL DEVICES
New Proposal on MDR
No provision for 3D
printed MD

14. MEDICAL DEVICES
FDA Additive Manufacturing Workshop (October 8-9 2014)
§ technical challenges and solutions to 3D printing
§ input regarding technical assessments related to AM
§ transparent process for future AM medical device submissions
§ future regulation of 3D printed medical devices

15. MEDICAL DEVICES
FDA Additive Manufacturing Workshop discussion topics:
§ Preprinting considerations:
– material chemistry
– physical properties
– recyclability
– part reproducibility
– process validation
§ Printing considerations:
– printing process
characterization
– software used in the process
– post-processing steps
– additional machining
§ Post printing considerations:
– cleaning/excess material
removal
– effect of complexity on
sterilization and
biocompatibility
– final device mechanics
– design envelope
– verification

16. MEDICAL DEVICES
FDA Additive Manufacturing Workshop: some findings:
§ encourage publication of failures, of situations where
inconsistency is found, and of defining such inconsistencies in
the context of the application
§ define additional requirements
§ establish additional standards or test methods to
demonstrate such consistency
§ Outstanding questions
§ FDA is actively seeking input from stakeholders in industry and
academia
but

17. BIOPRINTING
subcategory
of 3D
printing
but the same
regulation can
not be applied
different
public policy

18. BIOPRINTING
§ Risks
– biosafety
– malfunction or failure
– black market for
synthetic human body
parts
– bioterrorism
§ Current regulatory
framework
– stem cell research: for
research purposes
– organ transplantation:
for a transplantation
into a human body
§ specific regulation is
needed!

19. BIOPRINTING
Regulation?
§ …Bioprinted organs and
tissues are not “original”
body parts…so they have to
be regulated as…
– products?
– medical devices?
– drugs?
– …a new category?

20. BIOPRINTING
Ethical issues
treatment safety animal testing human
enhancement
moralization “playing God”
objection
justice and
access

21. BIOPRINTING
Regulation?
§ Ban?
– “safest” option, but
– prevent from saving lives
– paralyse innovation
§ No regulation?
– foster scientific progression,
but
– unsafe option
– unsuitable current regulatory
framework

22. BIOPRINTING
Regulation!
§ Multi professional
collaboration
– legislature and health
professionals – legal experts
– engineers– biologists –
computer programmers…
– wide use/keep in check
– suitable option
– encourage progression of
bioprinting

23. Promising signals
to continue on 3D printing path

24. Let’s hope regulation can keep up.
The Guardian

25. Avv. Maria Livia Rizzo, PhD
info@marialiviarizzo.com
marialiviarizzo.com