My production subcontractor informs me of a change in its manufacturing process and sends me its validation change file. Should I inform my notified body?
There are a number of guidelines that guide you in determining the importance of a change in design, production and the quality management system. Depending on the nature of the change to the classification of your medical device, the internal procedures of your notified body, you must inform your notified body about the change and await its agreement before accepting the change from your subcontractor.
Documentation for your subcontractor is not enough; as a manufacturer, you need to analyse and formalise the impact of change on the safety and performance of your products.
nex’design helps you:
- Formalise the change desired by your subcontractor;
- Analyse the documentation sent by the subcontractor, if any, and exchange with the contractor to obtain any missing information;
- Analyse the impact of change on the design of your product (safety and performance);
- Analyse the impact of changes on your processes including special procedures and their validation;
- If necessary, help the development of additional test protocols;
- Update technical documentation, the risk management review and the response to essential requirements;
- Submission of the change file to the notified body.
nex’design is an asset for:
- Mastering changes internally;
- Updating technical and production files;
- Creating a transparent relationship with the notified body by submitting complete applications in line with expectations.
What are the risks?
A substantial change made in production without supporting documentation demonstrating that the introduction of this change does not affect the safety or performance of your product can lead simply to withdrawal of your products or a recall of a non-validated product.