Ensure that your Quality Management System (QMS) is up to date and in line with the EU/EEA Medical Device Regulation (MDR) before 26th of May 2024.
Many medical device manufacturers, obliged to have a Notify Body acceptance and supervision, are still in the process of transfer from MDD to MDR and intend to use the advantages of further extension of MDD certification from its current Notified Body. To be able to use this advantage, application to your Notified Body for MDR assessment needs to be in place before the 26th of May 2024 and the achievement of an agreement no later than 26th of September 2024.
In addition, do not forget your Quality Management System (QMS) which is required to be in line with requirements stated in MDR no later than May 2024. A QMS certified according to EN ISO 13485:2016 also most likely needs additions and adjustments to fulfill MDR.
To establish, implement, maintain, and improve the QMS to ensure compliance with both the ISO 13485:2016 and MDR in an effective way, is not always obvious. There are often a lot of considerations to ensure that the QMS fulfills the purpose for the organization and applicable requirements.
If you need a second opinion or a GAP analysis of your current QMS in relation to the MDR requirement, contact us at firstname.lastname@example.org for more information.