Explaining IVD classification issues

IBS - White paper 2019

This white paper provides a historical perspective on the development of medical device and IVD device classification, explains the new rules and analyses the implications of the new system. Whilst it offers guidance, it should not be considered as a replacement for reading the full requirements of the Regulation.

Since the European Union started to regulate medical devices in the 1990s, a key element of the regulatory system has been the risk classification system based on human vulnerabilities. Its purpose was to ensure that devices would be regulated in a proportionate manner, whilst maintaining a high level of protection of health. The aim was also to minimize any unnecessary bureaucratic burden imposed on manufacturers. In particular, a rule-based system was devised to allow manufacturers themselves to identify the applicable risk class without having to formally apply for a classification decision from a competent authority or a notified body. It was also based on the realization that it would be prohibitively expensive to impose identical regulatory controls on all medical devices irrespective of the risk involved. The risk class would determine the appropriate conformity assessment route available to the manufacturer to achieve CE marking.

Classification and compliance requirements - Requirements applying to devices in all risk classes

Many requirements of the Regulation apply regardless of risk class, for instance:

Some requirements applicable to all devices should nevertheless be complied with in a manner that is proportionate to the risk class:

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Fonte: IBS

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