In the European Union, medical technologies are tightly regulated by laws that govern the safety and performance of devices across their lifetime, pre- and post-market. Over the next few years, the European medical technology sector will transition from being regulated under the current medical devices directives to two new regulations.
1. Classification of in vitro diagnostic medical devices
Today, the in vitro diagnostic (IVD) sector is regulated by Directive 98/79/EC. From 26 May 2022, the new Regulation 2017/746/EU will fully apply. Until this date, manufacturers can choose to comply with either the Directive or the Regulation.
Classification of IVDs is important as it determines the level of involvement by a third party (the “notified body”) in assessing IVDs both pre- and post-market. This level of control is generally relative to the risk of an erroneous result from the assay.
Bilaga II,
List A
e.g. AB0 blood typing
Bilaga II,
List B
e.g. blood glucose monitoring
Devices for self-testing
e.g. pregnancy tests
Self-detected devices
e.g. clinical chemistry analyser
Under the IVD Regulation, all IVDs will be classified under a new risk-based classification system according to the risk the device poses to the health of the public and or an individual as result of an incorrect test result. All IVDs will be classified under class A, B, C or D, with class D being the highest risk class.
2. Classification of medical devices
The medical device (MD) sector is regulated by Directives 93/42/EC and 90/385/EEC. From 26 May 2021, the new Regulation 2017/745/EU will fully apply. Until this date, manufacturers can choose to comply with either the Directives or the Regulation.
Classification of medical devices (estimated to be more than 500.000) drives many pre- and postmarket requirements. Due to the large variety of products, the level of control made by a thirdparty (the “notified body”) before placing them in the market depends on the level of impact on the human body that their use might imply. The same notified body is involved post-market to ensure the continued safety and performance of medical devices.
Under the MD Directive, MDs are classified into 4 classes following a risk based classification system:
Class I
e.g. simple bandages or wound care products
Class IIa
e.g. syringes for pump infusion
Class IIb
e.g. anaesthesia machines
Class III
e.g. pacemakers
Under the new MD Regulation, the risk-based classification system contained in the current Directives has been maintained, although some changes/additions have been introduced. The principle is the same: to link the class of the device to the potential risk posed to the health of the public and an individual as result of fault in the functioning. All MDs are classified under class I, IIA, IIB or III, with class III being the highest risk class.
This article is a slightly modified excerpt from The European Medical Technology industry in figures 2018.