Notification of production
or non-production periods 

Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) provide for regular unannounced audits, as they were already mandatory for notified bodies under Directives 93/42/EEC (MDD) and 98/79/EC (IVDD). This also applies to the ‘appropriate surveillance’ of legacy devices in accordance with Article 120 MDR or Article 110 IVDR, 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 vacation) at your or your subcontractors’ facilities (in the case of outsourced production), as this could have an impact on the fulfilment of certification requirements (see also respective certification rules). In the case of non-continuous production (especially at 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 periods by using the calendar function provided.

In order to allow us to take the reported times into consideration appropriately, they must be announced at least 3 months in advance. Please note that the reporting of these times is not binding for mdc regarding the non-performance or performance of an unannounced audit at the reported times.

The fields marked with * are mandatory.