In our previous post, we mentioned that as part of the setting up your Design and Development (D&D) work structure, you must determine the user needs and intended use of your product. This is important for your product risk classification and company’s regulatory strategy.
Due to differences in laws and regulations across international markets, the same product claim or intended use can require varying actions to be taken with regards to product classification and registration. To avoid as many obstacles as possible while bringing your medical device to market, it is best to keep this in mind and plan a regulatory strategy.
A regulatory strategy is often a formal plan that aligns regulatory activities to business strategy, so as to bring a new or modified medical device product to market. Formulating this plan would require your consideration of various regulatory issues in the target markets you wish to place your product. When well planned, your regulatory strategy should be balanced, realistic, achievable, and in support of your organisation’s mission and vision. It identifies important regulatory requirements to be addressed and provides overall definition and clear direction for your product development team, even outlining the reasons for the path to be taken.
Planning your regulatory strategy should be done at the earliest possible stage of product development, while you are putting your D&D work structure in place. Here are 3 points to consider with specific regard to regulatory concerns:
Target markets for commercialisation
Medical Device Classification
Overall project milestones and timeline
1) Target markets for commercialisation
“Which countries do I want my product to be sold in?”
It is important to know which markets you want to sell in, and prioritise the various market entries. Different markets have varying market size, medical practices, pricing and reimbursement, as well as distribution activities. Furthermore, regulatory regimes differ between markets. You would need to evaluate all these different factors when considering your regulatory strategy. It can be helpful for your D&D plans as well.
An example of regulatory difference is the risk classification of medical devices, where the same product might be classed slightly differently under different regulatory regimes. With this differentiation, the timing and ease of product release could be affected as well.
2) Product Classification
“Which risk classification does my medical device belong to?”
As mentioned above, medical device classification is important in establishing the pathway to a specific market. When you have clearly established the options and requirements for your “route to market”, you can better plan your product development with a “go-to-market” strategy.
Here are some links to a few of the more common regulatory markets to help you determine this:
EU Directive Product Classification on MDD, EU Directive Product Classification on IVD (valid till 26 May 2024, or MDD and IVDD certificates issued before dates of application* become void, whichever sooner)
Identifying your medical device classification correctly can allow you to clearly establish the relevant controls for your product development and risk management. It is also useful for understanding the risk profile of your product, as well as your competitors’.
Based on regulatory requirements for your medical device risk classification, you can determine the required scope of verification and validation, and thus estimate the cost and timeline to bring your product to market.
* Note: MDR date of application in 26 May 2020; IVDR date of application in 26 May 2022
3) Overall Project Milestones And Timeline
“What milestones can I look to gauge the progress of my project?”
Tying in with the above points, you would be able to craft your regulatory strategy when you have a clear idea of your target market’s regulations and requirements that need to be met. For example, you might find that certain markets require more extensive pre-clinical and clinical trials to be done, while others might request for relevant comparisons of your product.
Knowing this would also give you a good gauge of the time needed for each step of the certification and product registration process. You can then align your product development and business plans accordingly, to maximise your team’s efficiency.
With proper consideration of the key information mentioned, you can have a good grasp on your timeline for market entry and product development, as well as the cost involved. Accordingly, this means you are able to craft your regulatory strategy to bring your device to the market.
Crucial to meeting regulatory requirements throughout the world is having a proper QMS. The ISO 13485:2016 standard is often the reference for best practice QMS processes. You can read and learn more about the ISO 13485 here: