Originally, the 3-year transition period was to end on 26 May 2020, at which point the MDR would have become fully applicable.
Ever since the transition period began, it has meant considerable stress for medical device manufacturers, at whom the MDR is directed. The same is true for the Notified Bodies, which have the task of assessing and certifying implementation of the new regulations. They are under great pressure because they are having to adapt their own processes, while at the same time the number of Notified Bodies has been drastically reduced.
The crisis triggered by coronavirus led the European Commission to postpone the MDR implementation date by a year. So now it is important for manufacturers to utilise the extra time to update their instructions for use and product information, bringing them into line with the MDR provisions, and to obtain the required translations into other languages. The main focus should be on instructions for use (IFU), which are regarded by the regulations as an integral part of a medical device. An error or omission in the IFU could compromise the safety of a medical device and lead to marketing authorisation being lost.
This EU regulation specifies unambiguously that packagings and IFUs must be made available in the languages that are accepted in those Member States where the device is sold.
In theory, that could even mean all 26 EU languages.
medDOC has the specialist skills and resources needed to assist you in the process efficiently and cost-effectively:
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