Frequently Asked Questions (FAQ)

When will new MDR come into force ?

According to the official EU announcement MDR will come into force on 26th May, 2021 due to current global Coronavirus situation.

When will new IVDR be effective ?

EU In Vitro Diagnostic Regulation (IVDR, 2017/746) will be in force on 26th May 2022. After this date, medical devices will not be able to certified by old directive.

Where can I find the list of current accredited Notified Bodies ?

The list of accredited Notified Bodies can be accessed through the official website called as NANDO. Select appropriate legislation to see relevant NBs.

How long does it take to produce a CER / PER for a medical device ?

The time for a CER/PER will depend on many different but interconnected parameters. Most importantly, it will depend on the Class of the medical device, which will influence the amount of the data and relevant documents to be prepared, screened, and collected. Moreover, the process is also extremely dependant to the readiness of the mannufacturer in terms of providing and makin ready the all relevant documentations and required tests. To get an estimate please get in touch with our experienced team for a gap anlaysis from HERE!