Notification of production times
or non-production periods 

Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) provide for regular unannounced audits, as was already mandatory for notified bodies under the provisions of Directives 93/42/EEC (MDD) and 98/79/EC (IVDD). This also applies to the ‘appropriate monitoring’ of existing products in accordance with Art. 120 MDR, which are still placed on the market under the respective directive.

For efficient planning of unannounced audits, it is important that you inform us of any planned production downtimes (e.g. company holidays) at your company or your subcontractors (in the case of outsourced production), as this could have an impact on the fulfilment of certification requirements (see section 3.4.4 of the rules for certification in accordance with the Regulation). In the case of non-continuous production (especially for subcontractors), you can also inform us of planned production times instead.

On this page, we give you the opportunity to inform us of both non-production periods and production times. This can be done using the calendar function provided.

In order to be able to take the reported times into account appropriately, they must be announced at least 3 months in advance. Please note that the reporting of these times does not give rise to any entitlement to the non-performance or performance of an unannounced audit at the reported times.

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