This is an issue that has been subject of multiple consultations here in Australia - which has a regulatory system closely modeled the EC Directives. A couple of issues arise:
Custom device exemptions were initially written to allow regulators to exclude supervision of low risk things like spectacle lenses, moulded orthotics and the like which are manufactured to some sort of prescription to fit individual patients.
Now we have additive manufacturing techniques which allow custom manufacture of high risk implants.
Additive manufacture is also widely used to make non-custom devices where complex shapes can be made more easily than by older techniques such as machining or moulding. But in that case additive manufacturing is simply another production process - matters of customisation are not relevant.
The issue trying to be addressed by the "industrial scale" language is that of someone setting up a factory (even if it's a facility in a clinic) to use techniques such as additive manufacturing to make devices which are each individually fabricated to fit an individual patient, but are otherwise of the same type and intended purpose. Think custom maxillofacial implants - each are separate shape - but they are all maxillofacial implants for reconstructive surgery.
The US FDA deals with this very simply - by defining more than 5 pieces in one year of a single device type/intended purpose to be not eligible for custom exemptions. I believe the intent of the European regulations is the same.
The other issue is of course risk class. Where we are talking lower risk devices (orthotics, dental crowns etc.) then there will be very little regulatory oversight anyway. But things like orthopaedic implants - that's a different matter where regulatory oversight is necessary and the use of custom exemptions can result in circumstances of inadequate regulatory controls..
So how to interpret? I would suggest this simple approach: if the manufacturer involves serial production of many devices which, although each custom produced, are of the same intended purpose and same GMDNS (or other current nomenclature code), then you have industrial scale custom manufacture - which should be subject to conformity assessment and CE marking.
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Arthur Brandwood PhD FRAPS
Founder and Principal Consultant
Brandwood Biomedical
Sydney, Australia
Arthur@brandwoodbiomedical.com------------------------------
Original Message:
Sent: 12-Mar-2019 03:34
From: Xavier Canals-Riera
Subject: "mass-produced" exclusion of EU custom-made devices
Dear all
The definition of custom-made devices , in EU MDR art. 2, exclude the "devices which are mass-produced by means of industrial manufacturing processes"
"... (3) 'custom-made device' means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's 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; ..."
Simmilarly the EU MDR art. 5 for in house devices exclude devices manufactured on "industrial scale":
"... Member States may require that such 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. This paragraph shall not apply to devices that are manufactured on an industrial scale. ..."
As example of custom-made devices are the ear-plugs of the hearing aids made by industrial processes , ¿are these devics changing to need CE evaluation of conformity with NB evaluation?
Also the health centres use 3D printers, ¿are they "industial manufacturing processes "? can be considered manufactured on an "industrial scale"?
An example in dental manufacturing is Nobel Biocare which always considered their custom-made devices as manufactured on an industrial scale and their devices are CE marked with a NB intervention.
Thanks in advance for your help
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Xavier Canals-Riera
Director Tecno-med
Barcelona Spain
xcanals@tecno-med.es
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