I thought I had a solid grasp of all relevant EU-MDR clauses… until a recent Stage I audit by the Notified Body flagged something unexpected.

🔍 Annex IX, Chapter III, Section 8 – ever heard of it?

The auditor asked where we had documented a procedure to ensure that certain technical and regulatory documentation remains available to the competent authority in case the manufacturer goes bankrupt or ceases activity.

This clause is interesting because it places a requirement on Member States, not directly on manufacturers:

“Each Member State shall require that the documentation referred to in Section 7 [e.g. QMS, DoC, communication with Notified Body] is kept at the disposal of competent authorities [for 10 years or 15 years for implanted devices] in case a manufacturer or authorised representative […] goes bankrupt or ceases its business activity […]”

💡 The tricky part? In bankruptcy, management loses control and local insolvency laws take over. So how should this be handeled? In the Netherlands, for example, the intention of this requirement appears like the legal requirements to store certain financial records for at least 7 years post-bankruptcy or cessation of a business.
However, I couldn’t find any legal implementation of this MDR clause yet.

Still, Notified Bodies seem to expect some kind of procedure here.

For our client, an early-stage software medical device startup with no product on the market, we documented that they would download and store the relevant files alongside their financial admin. ✅ That was accepted.

Now let’s hope they never need to use that procedure.

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