A recurring question… with no single answer
Since the implementation of Regulation (EU) 2017/745 (MDR), a recurring question among medical device manufacturers is: how often should the technical file be updated to remain compliant?
The MDR does not set a single "calendar" frequency for updating the technical file. However, it imposes a continuous obligation: the manufacturer must establish and keep the technical documentation up to date.
The Key Principle of MDR: Continuous Compliance
The technical file must, at all times, reflect the actual state of the device as it is marketed (design, performance, risks, provided information, clinical data, etc.). In practice, the question is not "how often?" but "what triggers an update?".
An important point: clinical evaluation is not "fixed". The MDR specifies that clinical evaluation and its documentation must be updated throughout the device's lifecycle, particularly integrating data from post-market clinical follow-up (PMCF) and the post-market surveillance plan (PMS).
Triggering Events for an Update
In practice, an update to the technical file is expected whenever a change impacts the device or its evidence, for example:
- intended use, indication, target population, claims;
- design, materials, software, manufacturing process, critical suppliers;
- performance/safety data (preclinical or clinical);
- risk management and benefit/risk;
- vigilance (incidents, trends, corrective actions, FSCA);
- applicable regulatory requirements (general safety and performance requirements, standards, guides, interpretations).
Even if the product does not change, a post-market signal or clinical update can make part of the file obsolete, thus requiring a review.
Indirect Requirements That Structure a Minimum Rhythm
Without imposing a single frequency for updating the technical file, the MDR introduces deliverables that effectively create a reevaluation rhythm:
PSUR (Periodic Safety Update Report)
The MDR sets minimum frequencies according to the class:
- Class III and implantable Class IIb: at least once a year;
- Class IIb (non-implantable) and Class IIa: at least every two years;
- Class I: upon request, and at least made available to notified bodies and competent authorities when required.
If the PSUR or PMS activities highlight new elements (risks, benefit/risk, control measures), the technical file must remain consistent with these conclusions.
PMCF (Post-Market Clinical Follow-up)
The MDR defines PMCF as a continuous process that feeds into clinical evaluation and must be integrated into the PMS. Again, any significant clinical conclusion must be reflected in the corresponding documentation.
EUDAMED
As registration in EUDAMED becomes mandatory according to modules and regulatory milestones, the requirement for consistency between declared data and internal documentation gains operational weight (terminology, UDI-DI, certificates, actors, etc.).
Robust Practices in 2026: Manage, Trigger, Track
Even though the MDR does not specify "update every X months," a generally solid approach consists of:
- implementing a traced periodic review (e.g., planned document review, linked to the quality system);
- triggering updates "by event" (change control) without waiting for a deadline;
- maintaining clear traceability of versions, non-modification decisions, and associated justifications.
The challenge is not to multiply updates: it is to be able to demonstrate why an update was made (or not), when, on what scope, and with what impact.