MDR: The Pre-registration Phase (3/6)
In order to comply with the new EU MDR, the technical documentation files have to be drafted and gathered at the very beginning of the registration process as you need to have them ready prior to the registration of the device.
The technical documentation is addressed in article 10 and Annex II and III of the MDR. Annex II and III provide directions on how to present the technical file and a list of the documents to be included as well as instructions as regards to the translation:
The documentation "shall be presented in a clear, organised, readily searchable and unambiguous manner". (Annex II and III)
"All information and documentation necessary to demonstrate the conformity of a device will have to be accessible in an official EU language, as determined by the EU member state concerned". (Article 10.14)
This is an important linguistic change from the MDD as according to the latter only the first part needed to be translated and only in some cases. The MDR makes the translation of the whole documentation an obligation, in all cases.
On top of that, the IFU and the label, will have to be translated into the languages agreed upon of ALL the Member States where the device is envisaged to be sold.
Consistency in terminology throughout the numerous files and during required updates has been highlighted as an essential demand in the light of an updated regulation which wants to put forward clarity and readability for professionals as well as patients.
Baguette Translations has elaborated a quality process specific to MDR related technical documents in order to help you producing translations compliant with the MDR requirements.
Feel free to contact us for more details.