EU CURRENT AND FUTURE REGULATION OF 3D PRINTING OF MEDICAL DEVICES3D Medtech Printing Conference1 February 2017

Erik Vollebregtwww.axonadvocaten.nl

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

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?

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

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;”

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;

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

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,

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.

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’

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;

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

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

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THANKS FOR YOUR ATTENTIONErik VollebregtAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500M +31 6 47 180 683

E erik.vollebregt@axonlawyers.com @meddevlegalB http://medicaldeviceslegal.com

READ MY BLOG:http://medicaldeviceslegal.com