The global medical device regulatory space is becoming increasingly complex, making a well defined and researched regulatory strategy vital for medical device and in-vitro diagnostic (IVD) companies. With many changes planned for the next few years, a regulatory strategy ensures that you are well informed and aware of all existing requirements as well as any new or updated ones, which may impact the marketing of your device. We define the regulatory strategy as the ‘roadmap to market’ – because this describes the regulatory requirements that need to be addressed. There are a number of questions that you need to consider when developing a regulatory strategy. 1. Intended use Consider the intended use and design of your device as well any claims you make about the product. What are the proposed indications for use? You need to decide about the proposed indications for use that will be described in the instructions for use. An important distinction is between the ‘intended use’ which is precisely what your product is used for, whereas ‘indications for use’ are the situations and reasons where and why you would use your device. Both of these must be very clear and definitive, so it may take several iterations of these statements to get the wording correct; it is important so take the time to get it right. Another question to be addressed is, what is the regulatory classification of your device for each market in which you will be selling your products? In particular you must know whether the stated intended use changes the classification in any of those markets. 2. Device design Questions about the design of your device relate to the unique characteristics that are integral to the product. How could this impact the ability to demonstrate substantial equivalence with competing devices in certain markets? … Continue reading Why is regulatory strategy so important?