Do medical devices have to undergo clinical trials?

However, this design study is often much more difficult or impossible to implement for medical devices. Learn why if you don't properly document design controls, you'll end up paying for it later with more medical device complaints.

Do medical devices have to undergo clinical trials?

However, this design study is often much more difficult or impossible to implement for medical devices. Learn why if you don't properly document design controls, you'll end up paying for it later with more medical device complaints. In this free guide, you will learn how to start using FDA design controls to your advantage today and implement a process to actually improve your medical device product development efforts. While device trials have some basic similarities to drug trials, they have many different requirements and a common assumption for some CROs is that if they have participated in a drug trial in the past they will be able to take responsibility for a medical device trial.

John Lehmann is the director of business development at IMARC Research, a clinical research organisation (CRO) specialising in medical device trials. With regulators, payers and physicians demanding more data and even patients demanding to see clinical trials, medical device companies and CROs are starting to have to match biopharmaceutical companies in the number of trials being conducted. Given these differences, it is very important for a sponsoring company to ensure that the CRO it chooses has the relevant expertise in the medical device space. Just as pharmaceuticals can be divided into Phase I-III and Phase IV trials, medical devices can be divided into non-CE-marked and CE-marked trials.

These interventions can be medical products, such as medicines or medical devices, procedures, or changes in participants' behaviour, for example diet. When thinking of medical devices, complex instruments such as a hip prosthesis or a surgical robot may come to mind. In order for medical device companies to conduct a human study with a product of significant risk that is not yet approved for its intended use, an IDE approval is required. One of the main challenges for CROs that have worked in drug trials and are looking to move into the growing medical device sector is their own lack of experience with similar devices.

Greenlight Guru's eQMS software is an ideal solution for medical device companies that want to maximise their clinical trial readiness. Most medical professionals like to be at the forefront of new treatments, techniques and clinical products. However, in Australia, all medical devices, regardless of their class, must comply with the Australian Regulatory Guidelines for Medical Devices (ARGMD), which include requirements for device design and manufacture, benefits outweighing risks, minimisation of risks and unwanted effects, and so on. In contrast, the approval process for a medical device begins with a pilot study in which 10-30 subjects are enrolled.

Samantha Brookhouse
Samantha Brookhouse

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