Mdr Technical File Template

Fortunately imrdf or ghtf created a template called sted summary technical documentation medical device to help organize all the information but this was not mandatory per legislation.

Mdr technical file template. Technical file for medical device mdr technical documentation so called technical file for medical device is a comprehensive file covering complete information to demonstrate safety and performance of the device against the manufactures claimed intended usethe information given in the technical files are structured as per mdr and ivdr requirements suitably to address general safety and. It was just good practice. Mdr documentation submissions revision 1 september 2018 page 7 of 29 text recognition and bookmarks. A copy is also to be kept by authorised representatives eu mdr article 11.

Article 10 of the eu mdr makes the creation and maintenance of both parts of the technical documentation an obligation of all manufacturers. First you need to know that the eu mdr 2017745 is providing a clear view of what should contain a technical file when the mdd 9342ec was not so structured. What is the proper format for technical files. Ok weiterlesen weiterlesen.

This eu mdr technical documentation template will provide you all the necessary information that you need to gather. How will mdr 2017745 change eu technical file requirements. Other software formats may be acceptable but again these files will need to be converted to pdf files with bookmarks which will add time and cost to the review. Diese website benutzt cookies.

Significant delays may result if files cannot be easily converted to this. This technical documentation template conforms to eu mdr 2017745 annex ii and annex iii requirements. Wenn du die website weiter nutzt gehen wir von deinem einverstandnis aus. A ce marking technical file or design dossier class iii is a comprehensive description of your device intended to demonstrate compliance with european requirements.

The technical documentation is to be supplied to competent authorities when requested. 2379 page 1 of 4 the following structure is based on regulation eu 2017745 mdr but is also suitable for technical documentation according to di. Included to it is a checklist that will help you track if you have all the documents available. The ce technical file template has been developed following the requirements of the eu mdr 2017745 articles 10 annex i ii iii and ix including all other necessary requirements.