The definition of a substandard medical device has been clarified (such a device does not meet the safety and effectiveness requirements of medical devices, the requirements for their labeling, regulatory, technical and operational documentation and cannot be used safely for the purpose established by the manufacturer), and the concept of an “adverse event” has been introduced (this includes side effects not specified in the instruction / manual, adverse reactions when using medical devices, the interaction between medical devices, facts and circumstances of the adverse events, the identification of adverse events, and the necessity to report and report those adverse events to appropriate national authorities and health authorities).
In March 2012, Australian Standards of Medical Device Compliance (Australia) [ASMDC] was set up in response to industry requests to develop a set of guidelines for medical device compliance (and effectively, provide regulation itself as a trade association). However, ASMDC is not a regulatory body in itself; ASMDC is a platform for consulting, training and technical consultation in the development, use, evaluation and investigation of medical devices. The first ASMDC’s study showed that compliance with the health legislation required by the FDA in the United States is not an easy task. The report highlighted that the companies who participated in the study identified the need for more extensive training and support on areas such as medical device design (devising a system, carrying out a development and evaluation plan, and the importance of compliance with legal requirements), device compliance documentation (labelling and compliance with various requirements), and patient documentation (complaining to the government about side effects and reporting to regulatory authorities when an adverse event occurs).
Medical device compliance requirements vary in terms of cost and regulation
As mentioned, the regulation of the medical device industry has been set up in multiple countries across Europe, the United States and Asia; each of these countries has their own individual legislation.
For instance, in Australia, the National Health and Medical Devices Safety Committee (NHMDC) and Medical Device Regulation Office (MDRO) provides an overview of current regulation and guidance, as well as oversight and regulation for manufacturers and their agents.
As mentioned, it is expected that the Australian Medical Association will provide a platform to discuss ways of improving the regulation of the medical device industry.
There are some individuals in Europe who have developed medical device compliance requirements, but these have never been enforced.
For example, in the European Union (EU), one of the countries that has developed requirements for medical device compliance is the Netherlands. Netherlands has some important advantages such as no formal charges (and the possibility of obtaining a warning) for breach of the regulations; the Netherlands also has a strict and comprehensive quality control scheme for medical device suppliers (subsequently, there are around 400 accredited healthcare professionals in the Netherlands to carry out medical device assessments of compliance to the Dutch requirements).
Moreover, the Netherlands has a legal requirement that the manufacturer must produce all documentation related to the device, and this is done by a system of medical engineers who do not need any training.
Medical device manufacturers (and their independent consultants) need to comply with existing European regulations and their own individual registration procedure.
In terms of the cost, it is important to realise that all organizations that have medical device compliance requirements have invested in obtaining a certificate of registration and an endorsement. For example, a current registered medical device engineer working in the Netherlands can be certified by a healthcare professional (or graduate engineer or qualified pharmacist) with a three-year license to carry out assessments and evaluations.