Dirkjan Bakker
A clear requirement from the MDR is that the technical documentation must be maintained.
There are three routes that require the review and update of the technical documentation including the GSPRs. Each of these routes will be addressed:
1. Periodic Review
At least every year the current content of the Technical Documentation has to be reviewed to ensure its continued compliance with the MDR.
As a minimum the GSPR Checklist, Risk Management Report (revisions likely due to design changes, post-production and post-market surveillance information, risk mitigations, CAPA), post-production information including CAPA, PMS, PMCF and PSU per Article 83 – 86 of the MDR, Clinical Evaluation per Annex XIV, List of applicable (harmonized) Standards and, if available, common specifications will be updated in the technical documentation. Other parts of the technical documentation will be updated as applicable, e.g. due to design changes, updated shelf life information, sterilization and bioburden monitoring, re-validations.
If the review determines no further action is required, the review and decisions are documented in the appropriate document’s Revision History. Technical Documentation is updated and accepted internally by the appropriate responsible.
2. New or revised medical devices standards and / or legislation
The impact of new or revised standards and CS that have an impact on the technical documentation because of their potential effect on the de medical device’s compliance with a general safety and performance requirement will be assessed by appropriate subject matter experts. Examples are labeling requirements, product requirements, risk management and biocompatibility.
New or revised standards may result in a Change Order for the design or a re-evaluation of the design’s compliance with the GSPRs.
Decisions are documented in the document’s Revision History.
Required (technical) documentation Change Notice(s) and supporting documentation are prepared, assembled, and submitted for internal approval.
Revised technical documentation is approved and included in the design and development file.
See next for decision process as to the change being substantial.
3. Change Order
You have to decide if the change of the device part of the combination product is substantial (a change that could reasonably be expected to affect the safety or effectiveness of a medical device and should be notified to external authorities prior to implementation). If so, the below requirement apply as well.
The Notified Body is required to approve the change, the changed design is not made available on the market until the Notified Body has confirmed approval of the change.
Once the Change Order has been approved, the design change process is applied and following design change approval the Design History Dossier is updated.