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

Question

We are preparing to certify our Quality Management System (QMS) but do not yet have all of the technical documentation for our medical device completed. According to MDR 2017/745 (Annex IX, Chapter 1, 2.3 Audit), for class IIa or higher medical devices, auditors will want to see technical documentation to ensure that the QMS is correctly implemented. Our device is likely to be class IIa, but it is not yet certified. Should we wait until the technical documentation is complete before starting QMS certification, or is it possible to proceed with QMS certification while the device is still under development?

Dr. Oliver Eidel · Accepted Answer

Certification to ISO 13485 is independent from being a manufacturer under MDR Annex IX. Many certification bodies are not Notified Bodies for MDR, so you can get ISO 13485 certification without a complete technical documentation package. You need all QMS procedures in place and evidence that you apply them (internal audit, CAPA, management review, etc.). If you apply for MDR Annex IX conformity assessment, then you will need a full technical documentation file as a prerequisite. Strategically, it's common to certify your QMS first and finish technical documentation later.

Answer

It should generally be fine to move ahead with certifying your QMS even if your technical documentation isn't fully complete yet. However, the best approach is to check directly with your Notified Body, as their expectations can vary.

Answer

We recently asked our Notified Body to audit just our QMS first even though our technical documentation was delayed. Some NBs allow you to get ISO 13485 certification independently, or you can request it specifically. In our case, there was an extra cost because we had initially agreed to start with technical documentation, but it wasn't a big increase.

Answer

Our Notified Body told us there wasn't much advantage to getting ISO 13485 certification first—just extra cost. During our Stage 1 audit, they expected to see evidence that the procedures were actually being used, including in production and servicing. This can be tricky if your product isn't ready yet. So, it's best to check with your Notified Body or even different ones if you haven't chosen yet.

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

4 Answers

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