As far as compliance in Medical Industry is concerned, medical devices top the list in the health care industry. Compliance in medical devices is required mostly because of the new changes in the laws and policies by the ruling authority that affects the working and regulation of the medical devices every now and then. Medical devices save people's lives. It is, therefore, every organization's responsibility to ensure that they provide safe and sterilized medical devices for the healthcare industry. In order to ensure the safety and precautionary measures while performing on any medical device, one needs to be compliant enough to know the updated measures, surrounding the governance of the medical devices. Let's take a look at the latest updates in compliance with the medical devices in the healthcare and hospital industry.
Every medical device must comply with the standards of the national and international regulatory bodies that govern the principles to mechanize the use of the latest medical devices. The major Notified Bodies that perform the regulation of the laws and policies, which administer the use of the medical devices, are the FDA and the ISO. If the medical device has its regulatory use in the U.S., it is mandatory that it must comply with all the standards that are set by the FDA. If the devices are used anywhere else except the U.S., it must comply with the latest reformatory of ISO standards.
The organizations that constantly deal with the medical devices, must comply with the ISO standards. The ISO 9001, for instance, provides standards that can be beneficial to implement a sound Quality Management System. The latest edition of ISO 9001:2015, updates the requirements for setting new business which is small scale and needs limited compliance. The ISO 14000 deals with standards that concern about the environmental changes, recycling of products, packaging and labeling, and other important stuff affecting the environment in any given way. The updated ISO 14000 family of standards is the ISO 14006:2015. Considering the standards set for the medical devices, the ISO 13485 ensures that the medical devices must have a sound quality when they are deployed in the marketplace.
The organizations that are involved in the designing, producing and installing the medical devices, must comply with ISO 13485 standards. The 13485 standards, just like the other ISO standards, focus on implementing an effective management system for maintaining the quality in the medical devices. Since ISO does not provide any kind of certifications, the organization must conform to the standards set by the ISO and can get the certification done by a third-party. The conformity to the standards, when scrutinized by the third party, must appear to be valid in every way, as per the regulatory standards.
The revised ISO standard for medical devices is ISO 13485:2016, which has the latest regulatory norms, as per the recent advancements in the technological industry. The standards ensure that the organization must follow all the safety guidelines in compliance with the latest technologies, on which, the medical devices are implemented. These latest standards also have better clench on risk management and decision making based on meticulous risk assessment. It also affects the regulatory requirements that administer the food chain.
Apart from the updates in the ISO standards, new regulations have come into play concerning the Audit programs. With the failure of the Canadian Medical Devices Conformity Assessment System (CMDCAS), the Canadian market employed in regulating the medical devices in compliance with the CMDCAS structure will now have to follow the MDSAP standards. The Medical Device Single Audit Program, which is short for MDSAP, involves reduced inspection time and frequency with which the inspection is conducted. As MDSAP lays a strong guideline that restricts the old aspects of inspection, a single audit program will be enough to carry out a whole inspection.
Inspections with different inspecting entities can result in a complex process, and the findings in different functional areas can be different. This is comparatively a difficult process when inspection with a single entity is concerned. MDSAP instigates single entity for an inspection, which will have a single outlook towards the entire functional requirements of the QMS than the one with a different overview of the same process. This will provide a better picture of the functional requirement and how it can be effective with respect to the QMS. This consistent auditing program will require a less need for interconnectedness explanation and issues regarding translations.
The EU Medical Device Regulations, also known as EU MDR is another updated regulatory standard that requires the organizations, manufacturing the medical devices, to comply with the safety performance of these medical devices in the European countries. The EU MDR in association with In-Vitro Diagnostic Medical Devices Regulation (IVDR), in January 2016, drafted new guidelines that focus on the safety measure of the medical devices. In the new guidelines, the European Council has demanded the Notified Bodies to have perfect functioning to guarantee the quality and safety of the medical devices and In-Vitro Diagnostics. An unannounced audit will be conducted with regards to check the maintenance of the quality and safety norms and whether the standards are followed in compliance with regulatory bodies. The unannounced audit must be carried out at least once in 5 years. Also, a regular check on the Quality Management System (QMS) and the manufacturer's sample in conformity with the technical documentation will be the major agenda of this unannounced audit.
It is crucial for the organizations dealing with the medical devices, to understand, how important it is to comply with the latest updates when dealing with medical devices are concerned. Underestimating these regulatory norms can cause the organization paying costly fines and penalties and may cost its market values for a time unknown. Hence, keeping a regular track with the latest updates from the Notified or the Regulatory Bodies is an important aspect in governing safety and quality measures in the medical devices.
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