Is it necessary to have technical documentation ready before certifying a QMS under MDR for a class IIa medical device?

Question

Our company wants to certify its Quality Management System (QMS) as soon as all documentation is ready, but we do not yet have all the technical documentation for our medical device completed. Based on MDR 2017/745 (Annex IX, Chapter 1, 2.3 Audit), it seems that for class IIa or higher medical devices, auditors may request access to the technical documentation (TD) during the QMS audit to ensure that the QMS is properly implemented.
Our device will likely be classified as class IIa, but it is not certified yet. Is it necessary to wait until the technical documentation is finished before certifying the QMS, or can the QMS be certified even if the device is not mature yet?

Dr. Oliver Eidel · Accepted Answer

It's generally fine to proceed with certifying your QMS before the technical documentation for your device is complete, especially if you are aiming for ISO 13485 certification. ISO 13485 certification is independent of MDR conformity assessment, and you don't need a full technical file at that stage. You do need to have all QMS procedures in place and be able to show evidence that you're applying them, including internal audits, CAPA, and management reviews.
However, if you're applying for MDR conformity assessment (Annex IX), then a complete technical documentation is required as part of the process. Some Notified Bodies may have their own interpretations, so it's always best to check directly with your NB about their expectations and whether you can split the audits (e.g., ISO 13485 first, then MDR conformity assessment later).

Is it necessary to have technical documentation ready before certifying a QMS under MDR for a class IIa medical device?

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