A Call out to all self-certified Class I Medical Device Manufacturers
Are you a self-certified Class I Medical Device Manufacturers?
In the case of Up-classification under MDR/IVDR, after 26th of May 2020, you will not be able to place your products on the EU market as a Class I device (no grace period). Act now –
- Determine whether under new regulations your device remains the same classification (self-certified) or not (not for most of the IVDs),
- If not, act now to meet the above compliance dates and to avoid bottlenecks at the end of the transitional period.
Do you have questions about implementing the new MDR or IVDR requirements?
Give us a call today!