Article 10(4) of the MDR requires the manufacturer to draw up and keep the technical documentation up to date. This is not a formality: documentation that no longer reflects the device actually placed on the market is non-compliant, regardless of its initial quality.
The question is not “should the documentation be updated?” — the answer is always yes if the device evolves. The real question is: at what point does a change trigger a formal update of the documentation, or even a notification to the notified body?
The triggers for an update
A change in design or specifications. Any change made to the device is a trigger: the technical documentation must reflect the device actually on the market. The extent of the revision and any involvement of the notified body then depend on the nature of the change.
Post-market data that modifies the benefit/risk ratio. Data collected under the PMS — complaints, vigilance data, PMCF results, clinical publications on comparable devices — can reveal risks not initially identified or alter the assessment of benefits. If these data modify the benefit/risk ratio, the technical documentation must be updated, in particular the CER.
Regulatory or standards developments. A new version of a harmonised standard listed in the documentation, a new MDCG guidance modifying expectations regarding a type of data, or an amendment to the MDR may require a revision of the documentation.
A change in intended use or target population. This is the most structural change: it may require a reclassification and a complete revision of the technical documentation.
MDCG 2020-3: guidance reserved for legacy devices
MDCG 2020-3 (Rev. 1) is often presented as the general guide to changes under the MDR. It is not: it clarifies what a significant change in design or intended purpose means under Article 120, i.e. for legacy devices still placed on the market under a certificate or declaration of conformity issued under the Directives. For these devices, a significant change means losing the benefit of the transitional regime. For a device certified under the MDR, it is not the applicable reference.
MDR-certified device: up-to-date documentation and informing the notified body
Every change, even a minor one, must be reflected in the technical documentation: Article 10(4) requires it to be kept continuously up to date, and each change is assessed and recorded in the QMS (change control). What varies with the significance of the change is the involvement of the notified body.
Annex IX, Section 2.4, requires the notified body that approved the QMS to be informed of any plan for substantial changes to the QMS or to the range of devices covered. Section 4.10 makes changes to the approved device that could affect its safety and performance or the prescribed conditions of use subject to the approval of the notified body that issued the EU technical documentation assessment certificate. A partial or full reassessment may then be required; the practical arrangements are set out in the contract with the notified body.
Sources: Article 10 and Annex IX of Regulation (EU) 2017/745 — EUR-Lex; MDCG 2020-3 Rev. 1 — health.ec.europa.eu