Electrical safety in medical devices is very important to ensure the safety of both patients and caregivers. The regulatory world of medical electrical devices can seem complex at times, especially with the transition to MDR and its new requirements. But, as always, we at Key2Compliance try to make the complex easier for our clients. As a full-service partner that offers complete solutions for all our customers’ needs, we have the expertise to help with the safety and performance of medical electrical equipment and meeting the requirements of both the IEC 60601-series and MDR. Our electrical safety expert Gustav Sundström will tell you more about this field and how to develop a safe and successful product.
Gustav is one of Key2Compliance Regulatory Affairs (RA) consultants. With a degree in aeronautical engineering and more than 14 years of experience in electrical safety testing of medical and laboratory equipment, Gustav knows how to work with technical documentation for medical devices and help clients with electrical safety. As an important part of the RA team, Gustav is mainly working with technical documentation for MDR 2017/745. He is helping companies who are developing new products as well as those that have had products on the market for a long time to meet the new regulations.
“A big part of my job is working with MDR and helping our clients understand the new regulations, and what it means for them” says Gustav. “Right now, there are many manufacturers of medical devices that are struggling to understand what they need to do to get approved according to the MDR and get a CE marking for their product. We are assisting companies that just have an idea on paper and need to gain an understanding of the requirements they need to meet in the development process, and manufacturers that have had their product on the market for a long time but now have to update their technical documentation to meet the new requirements. By guiding them in what they need to do, we can help them save a lot of time and ensure that they get everything correct from the start.”
Gustav and his team like to get involved as early as possible in the process because it saves time for the client, and everything gets done correctly from the start. “We mainly work with companies that don’t have the electrical safety competence themselves. Key2Compliance can help in so many areas, from training and quality and regulatory affairs to biological and chemical testing and clinical evaluations. Electrical safety and its technical documentation are a natural part of that. In order to conduct a clinical study, you need to have a large part of your technical documentation in place. That’s where we come in.”
The workflow of the electrical safety process depends on what kind of client it is. Companies that have just begun working with the development of their product usually ask for assistance when the idea is still on paper. “We can step in and help them understand what’s required and set up a regulatory strategy of what needs to be done in this process,” says Gustav. “We prefer to get involved as early as possible. Then we can ensure the clients get everything right from the beginning, and they can avoid missing something that can delay the development of the product. We start by looking at what kind of product it is, what is considered its intended purpose, that is then used to assess whether it is a medical device and how it should be classified. There are different risk classes in the MDR with different requirements. When we know which risk class it is, we can start producing the technical documentation, describing the product, do risk management, help with studies in electrical safety testing, and more. All this needs to be done before you can move on to performing clinical studies.”
When it comes to clients that already have a product on the market and need to make sure it meets the new regulations, the process looks a little different. “When we assist those who already have a product on the market and maybe need to perform additional tests to show that the product meets the requirements, we start by looking at what’s already there. We do a GAP-analysis to figure out what they have and what’s required. Then we help them produce more data and, if it’s needed, do additional testing to show that the product meets the requirements.”
“In the end, all technical documentation must be submitted to a Notified Body, where it will be reviewed and generate a certificate,” says Gustav. “What we can do is write reports, help produce the technical documentation, be involved in the testing of products, for example, to meet electrical safety standards. We do everything we can to make this process as quick and efficient as possible, helping the client get a CE-marked product.”
With the transition to MDR, the regulations have become more detailed, and they also cover more products. This has caused a growing demand for having medical devices and their technical documentation assessed by Notified Bodies to see if they meet the requirements of the Medical Device Regulation. Gustav’s advice to the manufacturers is to plan ahead. “Right now, there is a queue for Notified Bodies, and we recommend contacting them early to find out if they review that specific product and how long the process is. This can take time, and it’s good to plan for that.”
Planning ahead is Gustav’s general advice when it comes to electrical safety. “Look at the requirements and standards before starting to build the product. If you don’t meet a standard, you may have to go back to the drawing board. Being prepared saves time and gets the product on the market sooner. And we can help with that process. We can also assist in regulatory support during development, review of a suggested design, standard identification, and risk management of medical electrical devices. If you’d like to learn more about electrical safety, MDR requirements and the IEC 60601-series, get in touch with us and we’ll help you.”
