I have heard several customers over the last years asking for a gap analysis and here is what I told them:
A gap analysis between MDD and MDR is a lot of work for almost no benefit.
The MDR contains a lot of information and by far not everything has an impact on economical operators.
-> so filter what is important for your business
The MDR contains a lot of requirements, which were already part of (harmonised) standards (e.g. ISO EN 13485:2016, ISO EN 14971:2012, ISO EN 14155:2011) or guidances (e.g. MEDDEV 2.7/1)
-> I guess most of the people here work in companies, which are already producing/selling devices. The main pillars of regulatory compliance are:
and all this should be part of a working quality management system.
This is nothing new but the status how it already should be.
So in order to comply with the MDR, instead of torturing yourself through articles about how frequently the MDCG shall meet or how the commission shall establish the interface of Eudamed (and also searching for equivalences in the MDD for that), it may be smarter to check for gaps between what you already have established and what the MDR requires.
Additionally, if you have already or are about to implement standards like ISO 13485:2016 or IEC 62366-1, you would have twice the work (first the gap analysis between MDR and MDD; second the gap analysis between standard and MDR).
The technical documentation is another good example for this. The MDD has almost no requirements on the format of the technical documentation. So people decided to use templates like STeD. If you use such a template, where is the benefit in comparing MDD and MDR requirements on this topic.
There are sections where a gap analysis between MDR and MDD might help (general safety and performance requirements <-> essential requirements), but for the whole document this is not helpful
The MDR is no MDD 2.0.