custom medical case devices are devices specifically tailored to the needs of an individual patient, produced based on a written prescription from a healthcare professional and featuring features or design characteristics tailored for that patient.
These devices are exempt from inclusion in the ARTG, but must still abide by Australian regulatory requirements. This includes providing appropriate documentation with each device and maintaining records related to them for at least five years.
?What is a custom made device in dentistry
Custom made devices are medical devices specifically prescribed by a dental professional. These may include prosthetic devices, bruxism splints and speech prostheses as well as other appliances tailored to each patient’s individual needs.
Custom-made medical devices are exempt from the US Food and Drug Administration’s (FDA) premarket clearance or approval requirements. To be sold and distributed within Australia, they must also be listed on the Australian Register of Therapeutic Goods (ARTG).
According to the FDA, a custom device is defined as “any device which, in order to meet an individual physician or dentist’s order, deviates from devices generally available or from an applicable performance standard or premarket approval requirement.” Therefore, all medical device manufacturing must take place in accordance with that prescription.
The role of manufacturer is typically shared between a prescriber and dental professional who fabricates the device. The latter “manufactures or fully refurbishes” the item for the health professional who prescribed it.
In the UK, custom-made devices were previously subject to European Union (EU) Directive 93/42/EEC which took effect in 2002 with Statutory Instrument 2002/618. On February 25, 2021 this directive was replaced by EU Regulation (EU) 2017/745 known as the Medical Device Regulation.
?What are they used for
Custom made medical devices are used in a variety of health care settings, from hospitals and clinics to rural and remote regions. They play an integral role in the global healthcare system by providing access to essential treatments, screenings, diagnosis, interventional procedures and palliative care.
In the United Kingdom, custom-made devices are governed by the EU Medical Device Directive (MDD), which was transposed into UK law through The Medical Device Regulations 2002. After Britain left the EU in 2004, however, this framework for custom-made medical device production changed drastically.
Under the new definition, custom-made devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). This means manufacturers must abide by MHRA regulations.
According to MHRA guidance, manufacturers must notify the Therapeutic Goods Administration (TGA) if they produce or supply custom-made medical devices. You must display a label identifying your device as a ‘Custom-made device’ and guarantee you have notified TGA within two months of production or initial supply.
Some custom-made devices require materials not readily available through existing additive manufacturing processes. If this applies to you, consider alternative techniques like vacuum casting or powder bed fusion; these are more accurate but may be costlier alternatives.
?What are they doing
Custom made devices are a unique type of medical device, defined in the Regulation as any medical device that differs from those generally available for sale or from a dispenser in terms of design characteristics specified by a healthcare professional in writing to its manufacturer.
These devices are intended to address specific anatomical, physiological and/or pathological features of a patient (and their needs) and should be designed with these considerations in mind.
Common examples of these devices include spectacle frames and optical glasses, plates to fix a broken bone, and cutting guides for knee arthroplasties.
Under the new framework for regulating personalized medical devices, they are no longer exempt from regulation by the Therapeutic Goods Administration (TGA) and must be included in the Australian Regulatory Tracking Guide (ARTG) before supply. Furthermore, they must abide by all other relevant regulations (like providing patient information leaflets and implant cards).
The MHRA guidance document on custom-made devices outlines some of the key issues to take into account when prescribing such devices. It also specifies who is accountable for manufacturing and health professionals issuing written prescriptions for these items.