You and your team have been working hard to gain approval and successfully launch your device. However, you may be forgetting an important consideration for market success: reimbursement.
Are your CERs ready for MDR?
Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …