In most jurisdictions medical software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device. Also, there are a number of international guidelines for medical software published by the Medical Device Regulators Forum (IMDRF). It is recommended to take them into consideration during development of your medical software products.
In most jurisdictions medical software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device. Also, there are a number of international guidelines for medical software published by the Medical Device Regulators Forum (IMDRF). It is recommended to take them into consideration during development of your medical software products.
In the European Union medical software, regardless of whether it is deemed to be a medical device or a part of a medical device, falls within the provisions of one of the European medical device regulations: Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Either way, during development of the software for European market, the Guidance on Cybersecurity for medical devices MDCG 2019-16 should be taken into consideration.
According to FDA, software, which on its own is a medical device – Software as a Medical Device – is one of three types of software related to medical devices. The other two types of software related to medical devices include software that is integral to a medical device (Software in a medical device) and software used in the manufacture or maintenance of a medical device. All the three types of medical software are regulated by respective sections of the Title 21 of the Federal Code of Regulations (CFR). Besides, if you develop medical software for the US market it may be beneficial to follow the IMDRF recommendations, which might facilitate the FDA-clearance of your product.
In Mercosur countries and in Mexico the medical software market is ruled by general medical device regulations that are applicable to all medical devices including medical software.
In the European Union medical software, regardless of whether it is deemed to be a medical device or a part of a medical device, falls within the provisions of one of the European medical device regulations: Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Either way, during development of the software for European market, the Guidance on Cybersecurity for medical devices MDCG 2019-16 should be taken into consideration.
According to FDA, software, which on its own is a medical device – Software as a Medical Device – is one of three types of software related to medical devices. The other two types of software related to medical devices include software that is integral to a medical device (Software in a medical device) and software used in the manufacture or maintenance of a medical device. All the three types of medical software are regulated by respective sections of the Title 21 of the Federal Code of Regulations (CFR). Besides, if you develop medical software for the US market it may be beneficial to follow the IMDRF recommendations, which might facilitate the FDA-clearance of your product.
In Mercosur countries and in Mexico the medical software market is ruled by general medical device regulations that are applicable to all medical devices including medical software.
MDRC assists medical device companies with regulatory approvals and placing medical devices, including medical software, on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post-market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them. What regulatory approval procedures are needed to place medical software on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
MDRC assists medical device companies with regulatory approvals and placing medical devices, including medical software, on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post-market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them. What regulatory approval procedures are needed to place medical software on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
*In the European Union medical software may fall within the provisions of either Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Depending on which of the regulations applies, medical software will be classified as classes I, II, II, IV or A, B, C, D, respectively.
*In the European Union medical software may fall within the provisions of either Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Depending on which of the regulations applies, medical software will be classified as classes I, II, II, IV or A, B, C, D, respectively.
What regulatory approval procedures are needed to place medical software on a market depends on the intended use of the software and its classification. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
What regulatory approval procedures are needed to place medical software on a market depends on the intended use of the software and its classification. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
Some gadgets can be used for medical purposes. In that case they can be considered by regulatory authorities of different countries as medical devices. Or parts of a gadget can be deemed to be medical devices (usually, the software) while the gadget itself is not. To determine whether a gadget is a medical device, its parts are, or both / neither of them, one should reference the device's intended use.
For example, a mobile smart phone would not be considered an accessory after having downloaded a medical application (app). The mobile smart phone would not be considered an accessory because it was not specifically intended for use with the medical device.
Some gadgets can be used for medical purposes. In that case they can be considered by regulatory authorities of different countries as medical devices. Or parts of a gadget can be deemed to be medical devices (usually, the software) while the gadget itself is not. To determine whether a gadget is a medical device, its parts are, or both / neither of them, one should reference the device's intended use.
For example, a mobile smart phone would not be considered an accessory after having downloaded a medical application (app). The mobile smart phone would not be considered an accessory because it was not specifically intended for use with the medical device.
In the European Union medical gadgets or their parts (e.g. the software) fall within the provisions of one of the European medical device regulations: Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the product stated by the manufacturer. To place a medical gadget on the EU market the manufacturer should determine what parts of the product (or the entire product) are viewed by the authorities (Notified Bodies) as medical devices and make those parts (entire device) compliant with the relevant provisions of the relevant regulation.
In the USA the provisions for medical gadgets are set out in the Code of Federal Regulations (parts applicable to medical devices and in vitro diagnostic medical devices) and in the section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As medical devices FDA considers standalone gadgets and mobile applications or gadgets and mobile applications used with an FDA-cleared / approved device and transforming a mobile platform into a medical device.
In the Mercosur countries and Mexico the medical gadgets market is regulated by general medical device regulations.
In the European Union medical gadgets or their parts (e.g. the software) fall within the provisions of one of the European medical device regulations: Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the product stated by the manufacturer. To place a medical gadget on the EU market the manufacturer should determine what parts of the product (or the entire product) are viewed by the authorities (Notified Bodies) as medical devices and make those parts (entire device) compliant with the relevant provisions of the relevant regulation.
In the USA the provisions for medical gadgets are set out in the Code of Federal Regulations (parts applicable to medical devices and in vitro diagnostic medical devices) and in the section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). As medical devices FDA considers standalone gadgets and mobile applications or gadgets and mobile applications used with an FDA-cleared / approved device and transforming a mobile platform into a medical device.
In the Mercosur countries and Mexico the medical gadgets market is regulated by general medical device regulations.
MDRC will help you place your medical gadgets and software on your strategic markets, regardless of complexity of your products and intricacy of the applicable regulatory processes.
MDRC will help you place your medical gadgets and software on your strategic markets, regardless of complexity of your products and intricacy of the applicable regulatory processes.
*In the European Union medical gadgets and software may fall within the provisions of either Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Depending on which of the regulations applies, medical gadgets and software will be classified as classes I, II, II, IV or A, B, C, D, respectively.
*In the European Union medical gadgets and software may fall within the provisions of either Regulation EC 2017/745 (general medical devices) or Regulation 2017/746 (in vitro diagnostic medical devices), depending on the intended use of the software. Depending on which of the regulations applies, medical gadgets and software will be classified as classes I, II, II, IV or A, B, C, D, respectively.
We will put your medical devices on your strategic markets in a timely and cost-efficient manner. MDRC are experts on all types and classes of medical devices. Entrust your regulatory affairs to the professionals.
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