3D medtech printing conference maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation

1. EU CURRENT AND
FUTURE
REGULATION OF 3D
PRINTING OF
MEDICAL DEVICES
3D Medtech Printing Conference
1 February 2017
Erik Vollebregt
www.axonadvocaten.nl

2. Agenda
• 3D printing of medical devices under EU law
• Basics of current regulation under Medical Devices Directive
• 3D relevant highlights from future regulation under Medical
Devices Regulation
• Custom made devices regime
• Hospital produced devices regime
• Nanomaterials
• For more general materials on EU regulation of 3D printing of medical
devices, see my blog http://medicaldeviceslegal.com
• For materials about specific industries (dental, orthopedic, etc.)
contact me

3. Medical Devices Directive
• Your 3D printed product is
• Medical device?
• Accessory?
• Component?
• Rule of thumb: MDD treats 3D printed medical devices and accessories
to medical devices as ‘custom made devices’
• Prescription by qualified person
• Annex VIII dossier
• No QMS
• Who is ‘manufacturer’ for regulatory purposes?

4. MDR
• The new Medical Devices Regulation is now a fact
• It will regulate medical devices and accessories for decades to
come in the EU
• Regulatory philosophy largely similar with some marked
departures from current policy
• What are the most relevant points for 3D printing industry?
• New custom made devices definition brings more devices
out of scope of custom made devices regime and in scope of
‘normal’ medical devices regime
• Hospital produced devices regime will allow hospitals to print
their own devices but restricts possibilities more than
hospitals would like
• “Who is manufacturer?” question unresolved and aggravated
by limitation of private label devices under MDR
• “Accessory” definition significantly expanded with devices
that “assist” a device’s medical intended use

5. Custom Made Devices
• 3D printed medical devices currently regulated as custom made devices in the EU
• 3D printing is a strategic item for hospitals – they will seek to combine their own
research with external and internal printing capablities
• Current definition in MDD
“‘custom-made device’ means 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.
The abovementioned prescription may also be made out by any other person
authorized by virtue of his professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific
requirements of the medical practitioner or any other professional user shall not be
considered to be custom made devices;”

6. Custom Made Devices
• Changes:
• Scope of prescribers
• Industrial mass-production of 3D printed devices (BIG change)
• Article 2 (1) (3) MDR:
‘custom-made device’ means any device specifically made in accordance with a
written prescription of any person authorised by national law by virtue of this
person's professional qualifications which gives, under his responsibility, specific
design characteristics, and is intended for the sole use of a particular patient
exclusively to meet their individual conditions and needs.
However, 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;

7. Custom Made Devices
• Consequences:
• ‘Industrial’ mass-production of 3D printed patient specific prescribed devices
will no longer fall under custom made devices regime
• Manufacturer will need full technical documentation and QMS that is
proportionate to the risk class of the device
• MDR increases requirements considerably compared to MDD, especially
for implants and devices that contain or consist of nanomaterials
• Parallelising 3D print companies and hospitals will have difficulties
meeting these requirements - “all-in” or “all-out”
• Most custom made devices printers are not ready for this
• Neither as manufacturer
• Nor as subcontracted producer

8. Hospital Produced Devices – ideal for home
printed devices?
• MDR HPD regime mirrors IVDR HPD regime
• Article 4 (4a) “With the exception of the relevant general safety and performance
requirements set out in Annex I, the requirements of this Regulation shall not apply
to devices, manufactured and used only within health institutions established in the
Union, provided that the following conditions are met:
(aa) the device is not transferred to another legal entity,
(a) manufacture and use of the devices occur under appropriate quality
management systems,
(b) the health institution justifies in its documentation that the target patient group’s
specific needs cannot be met or cannot be met at the appropriate level of
performance by an equivalent device available on the market,
(c) the health institution provides information upon request on the use of such
devices to their competent authority, which shall include a justification of their
manufacturing, modification and use;
(d) the health institution draws up a declaration, that it shall make publicly
available, including:
- the name and address of the manufacturing health institution;
- the details necessary to identify the devices;
- a declaration that the devices meet the general safety and performance
requirements set out in Annex I of this Regulation and, where applicable,
information on which requirements are not fully met with reasoned justification,

9. Hospital Produced Devices – ideal for home
printed devices?
(da) the health institution draws up documentation, allowing an understanding of the
manufacturing facility, the manufacturing process, the design and performance data of
the devices, including the intended purpose, sufficiently detailed to enable the
competent authority to ascertain that the general safety and performance requirements
set out in Annex I of this Regulation are met;
(e) the health institution takes all necessary measures to ensure that all devices are
manufactured in accordance with the documentation referred to in point (da), and
(f) the health institution reviews experience gained from clinical use of the devices and
takes all necessary corrective actions.
Member States may require that the health institutions submit to the competent
authority any further relevant information about such devices which have been
manufactured and used on their territory. Member States shall retain the right to restrict
the manufacture and the use of any specific type of such devices and shall be permitted
access to inspect the activities of the health institutions.
These provisions do not apply to devices which are manufactured on an industrial
scale.

10. Hospital Produced Devices – ideal for home
printed devices?
• Hospital will seek to compete with industry produced devices, if only out of scientific
curiosity and proof of concept
• Hospitals will have steep learning curve to meet the requirements:
• Quality system requirements, like production control
• Burden of proof for justification of need to make HPDs
• Unknowns
• National competence to restrict types of HPDs allowed (e.g. not implants)
• Concepts of ‘industrial scale’ and ‘mass production’

11. Definition of nanomaterial
• Article 2 (1) (15)
‘nanomaterial’ means a natural, incidental or manufactured
material containing particles, in an unbound state or as an
aggregate or as an agglomerate and where, for 50 % or more of
the particles in the number size distribution, one or more external
dimensions is in the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes
with one or more external dimensions below 1 nm shall be
considered as nanomaterials;

12. Nano classification
Many new 3D print basic
materials contain and/or
release nano size
particles, placing them
within scope of definition
of nanomaterial under
MDR

13. Classification
• Nothing new in 3D related classification specifically,
BUT:
• Rule 19: All devices incorporating or consisting of
nanomaterial are:
- in class III if they present a high or medium potential
for internal exposure;
- in class IIb if they present a low potential for internal
exposure;
- in class IIa if they present a negligible potential for
internal exposure.
Dental Tribune, 29 July 2015

14. www.axonlawyers.com
THANKS FOR YOUR ATTENTION
Erik Vollebregt
Axon Lawyers
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
M +31 6 47 180 683
E erik.vollebregt@axonlawyers.com
@meddevlegal
B http://medicaldeviceslegal.com
READ MY BLOG:
http://medicaldeviceslegal.com