Bringing a medical device to market is full of regulatory standards and regulatory authority certification that must be complied with and which must be integrated into the design and production of the device. In the medical device business, it is not enough to have just a good end-product; the development and production processes also have to fulfill very demanding criteria.
Every company working in the field must commit to ensure that high quality and regulatory requirements are met throughout the device whole life cycle. This requires deep understanding and knowledge of continuously changing regulations and standards.
But why is it so? Why are rules and regulations needed in medical business, and why is it that important to follow and meet them? And what kind of requirements we need to meet during different stages of the medical device life cycle – how is the medical device regulatory process like in practice?
In this page you will find some insights on how to ensure the quality compliance of medical devices throughout the whole medical device life cycle efficiently.
The following topics are addresses in this page:
- The role of rules and regulations in medical business
- Domain specific features – what need to be recognized?
- Medical and IVD device regulatory process in practice
The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. To ensure the safety and effectiveness of medical devices the regulations have to be taken into account throughout the entire medical device life cycle. It is mandatory to know and follow the regulations related to each life cycle phase of the product.
From the very early product specification and component selection phase to sales approvals, production processes, supplier control and even after-sales services, it is mandatory to know and to follow the regulations related to each phase.
In other words: the rules and regulations define how we in medical business operate, every single day.
As discussed earlier, it is not enough to have just a good end-product in medical business – the development and production processes also have to fulfill certain criteria.
This “certain criteria” that companies need to follow includes e.g. the quality management system (QMS), which is “must have” for every medical device manufacturer. QMS covers processes related to the medical device’s development, manufacturing and maintenance throughout its whole life cycle.
The QMS can be seen to be one key to ensure the success in the market. The well-established quality management system helps the companies to comply with current regulations as it establishes the company processes in a way that those align with regulatory expectations and standards.
We suggest you to partner with some professional in the field that can help you to proceed with all Quality and Regulatory actions; e.g., who can create and maintain certified QMS which is based on your own operation at the very practical level. Alternatively, you can outsource the design and/or manufacturing to a partner company who has the QMS in place and have only other functions covered in your QMS.
Read more about QMS as a key to your success from here!
In addition to QMS, the regulatory requirements concerning medical devices are compelling. For example, EU’s medical device directive describes how a manufacturer of medical devices has to operate. In EU, the new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The new rules will apply after a transitional period, which will come to its end on 26th May, 2020. From that date on the new MDR will apply fully. Due to the changes in the medical device legislation in the EU, there’s a lot of things you need to know as a medical device manufacturer. That’s why we’ve started a blog post series, where we discuss about the new MDR and its effects.
The operation is also regulated by other region and country-specific laws and legislations, such as FDA, that apply to manufacturers who export their products to the American market. More tips for medical device companies for US market entry from here.
The regulatory requirements are very strict and complicated – both in Finland and in international markets. If you find it too difficult to handle them by yourself, we suggest you to partner with some professional in the field that can help you to proceed with all Quality and Regulatory actions.
The rule number one is to start the balancing early enough. Medical device developers should remember that the identification of the regulatory requirements begins already when you come up with the new idea. Every medical device developer must have a suitable Quality Management System (QMS) as well – and the QMS efforts need to be started already right after the idea phase, because it need to be in place already during product development.
In addition to QMS, there is a lot more that need to be recognized and fulfilled at the design and development phase of the device. Companies should remember that there is both process and device related standards which must be taken into account in the design and developing phase. The device must satisfy all the criteria if the development is to proceed.
Market approvals for different market areas are naturally needed – there are many of them, as well, and companies must apply those depending on the market areas the company tries to reach. This must always happen before the device can be placed on the market.
And there’s much more that must be fulfilled even before manufacturing: e.g., the design transfer as well as production process validation phases have their own requirements, as well.
And when the manufacturing starts, the device need to be built according to the relevant standards and requirements throughout the entire production process. When manufacturing, you have to control that the design changes to the product are adequately transferred to production.
And because the life of a medical device does not end when it is sold to a customer, there are rules for post production phase, as well. The regulations require post-production activities to generate different kind of information regarding the use of the device.
To get even more detailed overview and description about the requirements the companies must meet during different stages of the medical device life cycle, please collect your free copy of our White Paper below!
The white paper shows the same, illustrated outline of the stages in developing your idea into a worldwide selling product in the medtech/healthtech sector – including more specific details what kind of actions, regulations and standards are required during each phase.
