Which aspects of MDR compliance should be main priority?

If your medical devices are already certified according to the MDD 93/42/EEC, first you need to check is there a change in the classification of your medical devices. In MDD there were 18 rules, in MDR 2017/745 there are 22 rules, so some medical devices have been changed to a higher class.

You can find Classification rules in EU MDR Annex 8 Classification rules: https://advisera.com/13485academy/mdr/classification-rules/

The next requirement that needs to be fulfilled is the requirement for the Post-market surveillance system.

This system is in detail explained in following MDR chapters:

• EU MDR Chapter 7 - Post-market surveillance, vigilance, and market surveillance: https://advisera.com/13485academy/mdr-heading/post-market-surveillance-vigilance-and-market-surveillance/
• EU MDR Annex 1 - General safety and performance requirements for each medical device or medical device family - https://advisera.com/13485academy/mdr/general-requirements

For more information about MDR, please see the following articles:

• EU MDR - Easy-to-understand basics: https://advisera.com/13485academy/what-is-eu-mdr/
• How can ISO 13485 help with MDR compliance?: https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/