Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) provide for regular unannounced audits – as already established under Directives 93/42/EEC (MDD) and 98/79/EC (IVDD). This also applies to the “appropriate monitoring” of legacy devices in accordance with Article 120 MDR or Article 110 IVDR, which are still placed on the market under the respective Directive.

To ensure these audits run smoothly, it is important for us to know when your production is taking place and when downtimes are planned.

On our new page “Notification of production or non-production periods”, you can now easily provide us with this information using the integrated calendar function.
This ensures that unannounced audits can take place during active production phases.

Go directly to the new feature:
https://www.mdc-ce.de/en/service-portal/notification-of-non-production-periods-or-production-times/