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As originally asked by Mara Caler.
Has anyone seen an updated Essential Requirements Checklist? I’ve heard that the new MDR will require significant updates to the ERC, and would like a head-start on getting our files in shape. Thanks for any suggestions.
Beluh Mabasa Ginting
Karen Zhou, RAC (Global)
Ee Bin Liew
no grandfathering so everyone ‘starts over’
increased requirements for ARs and NBs, causing a large shortage and potentially a huge bottleneck for approvals.
apply as an NB, anyone? 🙂
It is not too early to begin your EU MDR journey, there are significant changes to the requirements and organizational impacts to be considered.
Feel free to reach out to me directly with questions.
For risk management, I assume you comply with EN ISO 14971:2012. I believe that the new regulations will “undo” some of the content deviations. Again, there is enough information in the new regulations to perform a gap analysis on your risk management file, but I’d be nervous about closing any of the gaps because you might then be out of compliance with the MDD.
Sheikh Muneer Ahmad
I have some concerns that Annex I will be the least of the effort. Expect changes in UDI, PMS, Clinical Evaluation, etc.
The ‘General safety and performance requirements’ checklist can then be generated from Annex 1, to match the Essential Requirements in Annex 1 of the MDD 93/42/EEC. There are now 19 sections rather than the previous 13. This is what I have done i.e. producing a template. However, there may still be some minor changes before the eventual publication of the final MDR.
The final version is expected in the Official Journal in March or April. The final draft is available, and should be close enough to the official version to start work. You should be able to find it with a Google search.
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