Medical devices 101: 3 key takeaways

Medical devices are crucial for diagnosing, treating, and curing illnesses, diseases, and injuries. Vital for our health and wellbeing, the regulatory safety of these devices is taken seriously, with stringent requirements and access-to-market obligations in place to protect the public.  

In our Medical devices 101: beyond chemicals webinar, Global Product Compliance Manager Stacey Bowers provided a high-level view of medical device product compliance, including details of definitions and classifications in key markets.  

Read on for our 3 top takeaways.  

Understanding which classification a medical device falls into is a challenge for anyone responsible for product compliance, particularly as the definition of a ‘medical device’ varies so widely around the world. 

All jurisdictions follow a similar approach in classifying medical devices by risk and intended use, but it can be difficult for manufacturers to know which classification their product falls into in different countries.

1. US definition serves as a baseline

United States 

In the US, a medical device is categorized as: 

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part, or accessory which is: 

• recognized in the official National Formulary, or the US Pharmacopoeia; 

• 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 

• intended to affect the structure of any function of the body of man or other animals” 

Although this US definition is used as a baseline for many other countries, there exist important key differences and additions in other jurisdictions (see below), which manufactures of medical devices need to be aware of when seeking market access.  

Within the US, medical devices are regulated by the Food and Drug Administration (FDA). It has established classifications for more than 1,700 generic types of devices, grouping them into 16 medical specialities — for example: anesthesiology, cardiovascular, chemistry, dental, ear, nose and throat.  

Each device is assigned to one of three classes based on the level of control the FDA deems is necessary, the intended use, and the risk it poses to the patient and user.  

• Class I (lowest risk): bandages, handheld tools, manual wheelchairs 

• Class II (intermediate risk): CT scanners and IV infusion pumps 

• Class III (highest risk): Pacemakers and deep-brain stimulators 

The classification determines which type of pre-marketing submission manufacturers need to undertake. For a Class I or Class II device, they need to submit a 510k form. For Class III, they’re required to complete a 510k form and a premarket approval application if the product was on the market after 1976.  

2. China and India classifications are broader

China 

Regulation No. 276 of 2000 and Decree No. 15 of 2015 establish China’s approach to medical device safety.  

Similar to the above US definition, a medical device is: 

“any instrument, apparatus, implement, reagent for in vitro use and calibrator, material or other similar or related article, as well as necessary software with the specific purpose of: 

• diagnosis, prevention, monitoring, treatment or alleviation of disease;  

• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;  

• investigation, replacement, modification or support of the anatomy or of a physiological process;  

• support or sustaining life; 

• control of conception; or   

• providing information by means of examination of specimens derived from the human body” 

Unlike the US, China includes software used for medical purposes, and methods of contraception within its definition of a medical device.  

China’s National Medical Products Administration (NMPA) classifies medical devices into three categories:  

• Class I: subject to routine administration 

• Class II: medical devices that require further control 

• Class III: devices that are implanted in the body, provide life support, or pose a threat to health 

Manufacturers must register all relevant devices with the NMPA and devices importing into China must provide product samples to NMPA before approval to market. 

India 

In addition to the definitions above, India also considers surgical dressing and bandages, surgical staples and sutures, ligatures, blood and blood component collection bags, and substances including mechanical contraceptives as definitions of medical devices.  

Further, some of India’s ‘medical devices’ would be considered drugs in other countries. For example, they include disinfectants and insecticides. The devices are also notified occasionally under the Drugs and Cosmetics Act 1940. Manufacturers may struggle to bring the same medical device to market in India as they did in the US, for instance.  

In India, medical devices are classified by the Central Licensing Authority into the following groups based on their intended use: 

• Class I (low risk) 

• Class II (low to moderate risk) 

• Class III (moderate to high risk) 

• Class IV (high risk) 

All products must be registered through the Central Licensing Authority. 

3. Vulnerability of the human body part of the EU’s medical device definition

EU 

The EU’s approach to medical devices is established by Regulations (EU) 2017/475 and 2017/746.  

Similar to the US and China, the EU’s definition includes devices intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury, or disability. Specifically, a medical device is “intended by the manufacturer to be used, alone or in combination, for human beings”.  

The EU has this separate definition for an in-vitro medical device:  

“Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, used alone or in combination, intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of one or more of the following:​ 

• concerning a physiological or pathological process or state; 

• concerning congenital physical or mental impairments; 

• concerning the predisposition to a medical condition or a disease; 

• to determine the safety and compatibility with potential recipients; 

• to predict treatment response or reactions; 

• to define or monitoring therapeutic measures​; or  

• specimen receptacles are also in vitro diagnostic medical devices” 

Medical devices are classed using a risk-based system based on the vulnerability of the human body. The approach uses the following criteria to organize device types:  

• The duration of contact it has with the body 

• How invasive it is 

• Whether it produces a local or systemic effect 

• Its potential toxicity 

• Which part of the body is affected 

• If the device depends on a source of energy 

These classifications are laid out in Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR).  

Assessing risk to ensure market access  

The lack of consistency in how a medical device is defined and classified makes it extremely challenging for manufacturers to navigate market access for a chosen medical device.  

The first step to market access is dig into a jurisdiction’s definition of ‘medical device’ and review the applicable classification scheme. In doing so, manufacturers can assess whether their products are low, medium, or high risk in that specific country, and take advantage of any benefits from commonality.