How a medical device reaches the market
Gurge Phull gives a step-by-step guide to the route to regulatory compliance. The route to regulatory compliance of medical devices follows a similar process wherever you are in the world. To remove the risk of injury and harm to patients and users, medical device manufacturers must show that the device’s clinical benefits outweigh the risk of its use and the device is safe. In most cases this can be achieved through clinical reports and by testing to recognised standards. While the regulation process is rigorous, manufacturers have a duty to ensure that devices consistently meet both customer and all applicable regulatory requirements.
To streamline the approval journey, device manufacturers need to make compliance part of their company’s design process – starting with the initial concept of the device and then continuing throughout the whole development cycle. By ‘building-in’ the attributes that will steer the product or device away from any compliance and approvals pitfalls during the design phase, the product can be successfully delivered to market more quickly and economically.
During product design a systematic approach is applied to conceptualise and evaluate ideas into a tangible product prototype, whose evaluation and validation results in modifications and improvement to the design. Once clinical phase is completed, the design is locked down and transferred for production to manufacturing.
In simple terms, there are several key considerations when planning a new product’s route to regulatory compliance in the European Union as a minimum:
(i) device classification;
(ii) identify and meet essential requirements;
(iii) technical documentation;
(iv) conformity assessments;
(v) declaration of conformity; and
(vi) on-going market surveillance.
Device classification is the first step of any medical device approvals process and needs to take into account the potential countries in which the product will be marketed. Globally there are similarities in the classification coding, and the higher the classification, the more rigorous the regulation process becomes. It is vital to determine the appropriate classification for the medical device as early as possible to ensure you follow the correct route through the compliance submission process.
A diverse range of interconnected market regulatory requirements must then be met – from medical and engineering device evaluation, quality systems that govern processes, through to the documentation and the process of the formal application. These will vary from country to country and according to the device classification.
Risk assessment and compliance
Risk management relating to product safety is vital in the medical device manufacturing industry as it prevents product recalls and patient or user harm. The key standard used for this is EN ISO 14971, which examines the probability of the occurrence of harm and the consequences of that harm, i.e. how severe they might be. For example, the failure of a therapeutic medical device such as a glucose or insulin monitoring device could result in inaccurate readings and, subsequently, inaccurate doses, which could be very dangerous for the user.
Meeting these requirements must be demonstrated across all medical device stakeholders including governments, health care services, industry, patients and members of the public. It is therefore essential to ensure that your risk assessment is rigorous, appropriate and that the right evidence is present in your documentation.
The device is also assessed against other relevant standards. If the new product is an established technology, or makes use of established technologies in its production, will be easier to approve than an innovative product, on account of existing standards. An example is the quality management standard ISO 13485. This international standard defines Quality Management System (QMS) requirements within the medical device sector and is applicable to all manufacturers of medical devices and to those organisations that support medical device manufacturers. To ensure compliance, it is worth undertaking QMS audits and advice ahead of the formal approval process.
During device evaluation, a number of tests are completed that may include electrical and mechanical safety, electromagnetic compatibility (EMC), machine safety, wireless and radio compliance, environmental and reliability, clinical trials, usability, risk assessment and risk management, and software validation among others.
For example, certain medical devices, such as those with electro/mechanical drive systems, constitute a ‘machine’ and call up additional machinery safety requirements. These devices may require additional testing of components (or the complete device) to ensure they satisfy the relevant essential health and safety requirements of the Machinery Safety Directive.
Technical documentation must then be completed in the form of a technical file, sometimes known as a summary technical document or STED, to submit information for regulatory approval of the new medical device.
A typical STED may be divided into the following sections:
- device description/product specification;
- design and manufacturing information;
- essential requirements;
- risk analysis and control summary;
- product verification and validation; and
- declaration of conformity.
The long-term goal of STEDs is to globally standardise regulatory submissions.
Finally, capturing customer feedback and managing risk is crucial to the success and compliance of any medical device. Therefore, once the medical device/product is marketed to prospects, customers and others, the manufacturer must have a system in place for ongoing post-market vigilance. This is typically a two-pronged approach comprising manufacturer’s post-market surveillance and regulators’ post-market surveillance. This will allow for improved health and safety protection of patients, users and others by considering that the benefits of using the medical device outweigh the risks.
Introducing a new medical device to the market is always going to be a complex and costly process. However, companies can streamline the process by seeking expert advice early and invest time in planning the compliance journey from the onset. This not only benefits the manufacturer, whose success in launching the product to the marketplace is assured, but also provides essential benefits to the patients and practitioners who are able to gain access more quickly to the latest technologies in healthcare, safe in the knowledge that they have met the latest regulatory compliance requirements.