Before placing a product on the market as a medical device, it must first qualify as a medical device. This means that it must have an intended medical purpose and act primarily by physical means as set out in the legal definition of a medical device as outlined in the Medical Device Regulation (MDR) or Medical Device Directive (MDD).
Similarly, an in-vitro diagnostic medical device (IVD) placed on the market must correctly be qualified as an IVD and meet the definition outlined in IVD Regulation (IVDR) or IVD Directive (IVDD). These products are intended to be used for the in-vitro examination of specimens from the human body for the medical purpose of providing information on conditions, states, processes, diseases prognosis etc. This excludes general laboratory equipment such as some buffer solutions, pipettes etc. and research use only products.
Once a product meets the definition of a medical device or IVD, it must then be correctly classified. General medical devices are divided into four risk categories Class I (lowest risk), Class IIa, Class IIb and Class III (highest risk). Factors such as the degree of invasiveness, the part of the body affected, duration of use, and whether or not the device is active help determine the classification. In addition, the MDR also sets out special rules for certain devices such as contraceptives, substance-based devices, devices that contain nanoparticles, and those which contain a medicinal product.
Currently, products meeting the definition of an IVD under the IVDD can fall into one of four groups:
Under the IVDD there is no application of classification rules or classes. However, an IVD falling into one of these four groups must follow the conformity assessment procedure for that group, as outlined in Article 9 of the IVDD.
The IVDR replaces these four groups with a rule-based classification system. IVDs can be classified as Class A, B, C or D taking account of the intended purpose of the devices and their inherent risks. This classification system will be fully applicable from 26 May 2022 when the IVDR becomes fully applicable. IVDR-compliant devices can be placed on the market before this date in line with the transitional provisions (Article 110).
Regulatory requirements and the routes to market are heavily dependent on the correct classification of a device. It is ultimately the responsibility of the manufacturer to correctly qualify and classify their products, after which they must complete the appropriate conformity assessment procedures before placing them on the EU market. A full list of the relevant rules can be found in the Annexes of these Directives and Regulations, alongside directions on how to apply them appropriately.
Manufacturers are responsible for the correct qualification and classification of their products. However, in certain situations it may be difficult to determine if a product qualifies as a medical device, and if so, which class it falls under. In this case, you may seek advice from the HPRA. Classification requests may be referred to the HPRA’s Borderline Products Committee, which meets once a month, or externally to our wider European network.
Guidance on classification is available here:
For further information on the classification of medical devices or IVDs, please see the following links:
Medical Devices Directive 93/42/EEC, Annex IX
Medical Device Regulation 2017/745, Annex VIII
In Vitro Diagnostic Directive 98/79/EC
In Vitro Diagnostic Regulation 2017/746
MDCG Guidance on Classification of Medical Devices
MDCG Guidance on Qualification and Classification of Software
MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices
If you would like to know more information on classification of medical devices and/or IVDs please email email@example.com.