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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:

 

US
REGULATORY BASIS
Section 201(h) of the US Federal Food, Drug and Cosmetic Act, FD&C Act
LEGAL DEFINITION
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
1. recognised in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolised for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

 

EU
REGULATORY BASIS
Article 2(1) of Regulation (EU) 2017/745 on medical devices (EU MDR)
LEGAL DEFINITION
“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: 
1.diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
2.diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
3.investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
4.providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:

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:

  1. Describe your product and check the Regulatory requirements against this description
  2. Plan your market access activities in parallel to your regulatory strategy (Regulatory and Marketing strategy can go hand in hand) [Promo]
  3. 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

 

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