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 potential trigger. The MDCG has published the guidance MDCG 2020-3 specifically on this subject. It defines a “significant change” as any change that could affect the device’s compliance with the GSPR, or modify the intended purpose, or affect the safety or performance profile of the device.
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.
What a significant change is according to MDCG 2020-3
The guidance proposes a decision algorithm. A change is significant if it could affect compliance with the GSPR, if the new design affects the intended functioning, if the safety profile is modified (new materials, new failure modes), or if the change results in a modification of the device’s class.
A non-significant change does not require a formal update of the technical documentation or a notification to the notified body — but it must nonetheless be documented in the QMS change register.
The procedure for notifying the notified body
Certain significant changes must be notified to the notified body before they are implemented. If the change affects the certificate issued, a partial or complete reassessment may be necessary. The notification procedure is defined in the contract with the notified body.