With the development of 3D printing, custom-made devices are becoming widely implemented. Enabling unlimited personalized solutions, their manufacturing and usage are recently increasing very rapidly. However, this requires meeting a lot of requirements, regulations adjustment and documentation preparation. The regulations are still not clear enough and need a lot of adaptation and interpretation.
As defined by International Medical Device Regulators Forum (IMDRF), custom-made devices are the medical devices, that meet the following requirements:
- they are intended to be used by a particular individual, a patient or an authorized healthcare professional
- they are made in accordance and under the request of an authorized professional, who is responsible for designing specific characteristics and manufacturer consulting
- they are intended to meet the specific anatomy-physiological features or pathological condition of the individual
Also, it is important to outline that the custom-made device cannot be found or replaced by any other alternative on the market. This also has to be written and authorized by a professional in the form of a specific prescription and used with the requirements of the particular individual.
General requirements of the custom-made devices
Before introducing the custom-made device, a list of requirements needs to be met. This considers authorized documentation and a list of specific characteristics prepared by the healthcare professional. A manufacturer of the custom-made medical device (CMMD) is obligated to produce a statement to be able to place it on the market. This should include elements such as:
- date of the identification of the device (serial and order number, generic name etc.)
- the proof that the device is intended to be used by a particular patient (identification number, however with the maintenance of the confidentiality)
- the full name of an authorized person or a clinic who wrote the prescription
- the full name and address manufacturer
- the specific features of the device produce and fulfilment of the key requirements such as safety and performance in the written form
After ensuring that the custom-made device includes all of the requirements listed above, the device needs to get classified in accordance with the classification system. Safety and proper performance can be checked by validation of the software, modelling and simulation. The further step includes also physical testing, in which all the risks have to be considered.
Custom-made devices manufacturing
The custom-made devices have to be manufactured under specific requirements such as Quality Management System (QMS). Also, if the process involves high-risk medical-device production, it is recommended to have oversight from regulatory or auditing organizations.
In order to be able to supply the custom-medical devices, the manufacturer has to consider:
- providing proper infrastructure and appropriate environment of the manufacture
- method of device sterilization and infection control
- energy source connection or equipment requirements
- technical and manufacturing records documentation requirements
- impact of the biological, chemical and physical device properties
- Information and instruction of the device usage
What is also recommended is to:
- when requested from the regulatory authorities, being able to provide a copy of the written statement (manufacturing process, the aim of the custom-device production, conformity of the fulfillment of the regulatory requirements)
- retain the custom-made device documentation for 5 to 15 years
- enable a healthcare professional and the individual whom custom-made device was created an authorized statement
Custom-made devices manufacturers should be able to provide the authorities with the whole documentation and reports produced in the post-production and market surveillance process. Every responsible party such as a manufacturer, healthcare professionals or local representatives needs to follow requirements and investigate cases in the adverse-event reports to be able to identify the cause.
However, most of the custom-made medical devices’ regulations and jurisdictions are not applied in terms of the technology and have been mostly used in both experimental and investigation aim for now and this is what needs to be changed to move the industry forward.
Medical devices regulations according to the MDR, MDD and FDA
Due to the medical device regulations of European Medical Devices Regulations (MDR) and Medical Devices Directive (MDD), they are differentiated from these set up by Food and Drug Administration (FDA) in the US. The manufacturers who are struggling to get their approval for the product to enter the market are dependent on the rules included in the regulatory framework. They need to fulfil mostly in the aim of getting a higher vigilance and lowering the risks.
In order to receive FDA authorization on the market, steps regarding the safety and effectiveness have to be assured. The EU MDA is focused mostly on devices traceability and their performance. Also it covers economic operations, clinical information and regulatory, which regards notified bodies. What is included too is post-market, it’s vigilance and surveillance. All the regulations mentioned in the MDR are the ones that are replacing the previous Medical Devices Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD).
Generally speaking, the FDA is responsible for the authorization or controls and according to successfully complete it, EU MDR needs to ensure proper classification of the devices (Class I, Class II, Class III), conformity and in-detailed described procedures. The medical devices regulatory is complex and still needs a lot of adjustments to be brought to the market with success.
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