The bad news first: meanwhile, it should be clear to everybody that the MDR will not go away again and that it makes no sense to put your head in the sand in ostrich-like manner. The good news, we are all in the same boat and we would like to getting you into contact with peers to give your input on the MDR. In this case with the Technical Documentation according MDR.

 

Also under the new Medical Device Regulation (MDR) manufacturers need to establish and maintain a Technical Documentation as an evidence of conformity with the relevant legislation. Although medical devices can still be placed on the market under the provisions of the MDD/AIMDD as indicated in Article 120 MDR after 26 May 2020 under certain circumstances, manufacturers should prepare to update their Technical Documentation to MDR. This is also true for manufacturers of class I devices that are not provided sterile, have no measuring function and are not reusable surgical instruments even though no involvement of a Notified Body is required.

 

What makes the update of the Technical Documentation so complicated is, that the relevant information and requirements are spread over the whole MDR. Although, the relevant annex for the Technical Documentation according MDR is Annex II and Annex III, you should be aware that other articles and annex need to be taken into consideration. The Technical Documentation is for example heavily interwoven with Annex I (GSPR), and also the conformity assessment according to Annex IX to XI include requirements applicable to the Technical Documentation.

Annex II of the MDR shows that the requirements for the Technical Documentation have been increased compared to the MDD, but they are now also outlined in a clearer way. One change that might affect your Technical Documentation is the post-market surveillance (PMS): While products on the market have already PMCF data, user feedback, complaints and/or competitor analysis data available, new devices first need to establish these PMS data. Nevertheless,  it needs to be shown how this data will be generated. The data may consist of the manufacturers post-market surveillance plan (which might include a planned PMCF study), but should also include vigilance data from competitors already.

 

You have heard the following most probably already many times, but we can also only recommend to read the MDR, compare the new requirements with your documents, define the GAPs, evaluate suitable solutions, review and complete your templates and documents. Talking to peers who have gone already through this process, might help as well.

 

The slides for you to download are intended to provide you with a rough overview over the requirements for the new Technical Documentation and the possible actions that may need to be performed for gaining compliance. The presentation does not purport to be complete and only represents the understanding based on currently available information and guidance. Please keep track of ongoing discussions and monitor ongoing publications.
by Nicole Gabathuler, Senior Consultant, confinis ag

We welcome your thoughts and feedback and encourage you to get involved in our discussions - info.ch@confinis.com