Understanding the meaning of Medical Device and Medical Device Regulatory Strategy
Medical Devices are defined differently in different parts of the world. At times, device manufactures don’t even know if the product is a medical device or in fact, is a wellness product.
To erase this confusion, our experts have created a simple guide to clearly define and help you self-classify your medical device as per the regulations in the EU and the US markets.
Launching your product in the EU? We can be your EU Authorised Representative!
Let’s understand the legal definitions from the regulators:
The International Medical Device Regulators Forum (IMDRF) has taken several aligning efforts, yet there are regional differences in device definition, classification, requirements, and technical documentation. To understand these changes, let’s dive in deeper:
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devices for the control or support of conception;
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products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point”
Confused?
Find out how to identify your device as per USFDA guidance: Identify if your device is a medical device and as per European guidance: EU MDR guidelines
Apart from the definition of a medical device, every regulatory authority has further divided medical devices into certain classifications or ‘classes’. You can read here about product classification.
After defining your product, let us understand the meaning of Medical Device Regulatory strategy.
While developing your medical device and the sales plan, you will spend time determining and making careful decisions about your Target Market. The commercialisation strategy and plan should also consider the regulatory requirements of your target markets. Too often, manufacturers will ignore the regulatory requirements in their target market negatively impacting on the market reach of their innovation.
Lucrative factors like revenue and market share often overshadow the regulatory requirements, and manufacturers are lured into spending more time on economic advantage and, at their peril, ignore the regulatory considerations. While deciding on the target market, manufacturers should weigh up the potential lucrative economic factors with the regulatory requirements of that target market.
A well thought out regulatory strategy will provide you with a pathway to enhance your production, business development and marketing plans. Shortcomings in the regulatory strategy will directly impact the product reach in the market and hamper business activities. To avoid potential catastrophe, focus on this 3 point formula:
- Describe your product and check the Regulatory requirements against this description
- Plan your market access activities in parallel to your regulatory strategy (Regulatory and Marketing strategy can go hand in hand)
- Approach our medical device experts at Med-Di-Dia who will check your product is correctly classified and that you understand the regulatory pathway to commercialisation
With this 3 step formula, you will be able to protect your medical device from any regulatory mishaps. You’ve heavily invested time, money and resources into your medical device so don’t ignore the importance of regulations. If you do, you will put your business at risk, delaying innovation and denying future patients access to your device.
Remember: the medical device is your innovation and providing regulatory support is our passion!
Contact us now
Call: +353 (0)91-704804
Email: mdd@mddltd.com
Read More
- Who Can Sell in the USA and the EU Medical Device Markets?
- Can Medical Device Regulatory Strategy define Marketing Strategy?
- Aspects of Medical Device Regulatory Strategy
- Where to start with forming a Medical Device Regulatory Strategy?
