I run a small software development company and we’ve had experience of developing mobile apps for clients that are classed as medical devices, so they carry the CE mark. All our experience to date has been on developing class 1 safety class A devices for Europe so we have complied with the EU MDD . We’re not certified to 13485 but our software development processes are aligned to harmonised standards like IEC 62304 and we have always produced the Technical File for such projects which has been handed over to the client so that they can register the device with the MHRA in the UK. We have an opportunity to develop some software which under the new MDR will be classified as a IIa device but we are not sure if the Technical File structure/content areas that we’ve used for developing class I devices would be sufficient and meet the compliance requirements for developing class IIa device software? We also want to transition to the new MDR and we’re currently unsure how to approach this and was wondering what practical steps we could take to begin the process. Any help and advice from someone more expert on all this than myself would be much appreciated.