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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:
- The risk class and the justification for the classification rule(s) must appear in the technical documentation (Annex II, Section 1.1f)
- The risk class must appear on the declaration of conformity (Annex IV, Section 5)
- Registration in Eudamed3 with an indication of the risk class (Annex VI, Part A, Section 2.8)
- Quality management system procedures must cover classification ( Annex IX, Chapter I, Section 2.2c)
- Certificates issued by the notified body shall identify the risk classification of the devices concerned (Annex XII, Chapter I, Section 4)
- Various documents related to performance studies must identify the risk class of the device (Annex XIV, Chapter I, Sections 1.10, 1.12 and 2.1).
Some requirements applicable to all devices should nevertheless be complied with in a manner that is proportionate to the risk class:
Post-market surveillance system (Art. 78.1) Performance evaluation (Annex XIII, Part A, Section 1).