Cliff Notes
If this all seems overwhelming, Michelle McDonough, MS Director, Regulatory and Clinical Affairs and Mike Goodson, Associate Director, Regulatory Affairs from MCRA gave us the Cliff Notes of what you need to know.
- All MDD certificates will be considered valid after the date the MDR goes into effect (May 26, 2020) until they expire or until four years after the date the MDR goes into full effect (May 2024), whichever comes first.
- However, no significant changes are allowed during this period. A significant change is considered a change in the design and intended purpose as well as any change to the MDD certificate. For example, a change in the manufacturer’s address after May 26, 2020 is considered a significant change as it requires a change to the MDD certificate. It has been reported that NBs cannot legally issue any new or revised MDD certificates once the MDR is in full effect.
- Manufacturers still must comply with the MDR requirements related to post-market surveillance, vigilance, and registration of economic operators and devices
- Notified body back-log is forcing lengthy review periods and the review teams are giving little time for responses
- While there is an understanding that documents will need to be updated as industry learns the expectations, NBs are proving to be unforgiving if updates cannot be made extremely quickly, even when these documents were historically considered acceptable under the same NB’s review
- Some NBs have notified clients that they plan to cease operations due to the requirements under the MDR leaving some manufacturers without a NB in a time when NBs are stretched thin and not accepting new clients
- Company resources are stretched thin with ongoing MDD activities and updates to prepare for MDR. Company resources that were once adequate are proving to be insufficient
- Often this results in CERs not being updated to MEDDEV 2.7/1 Rev 4, delays in updating CERs, significant non-conformities from notified bodies, and often leaves too little time to make the necessary updates when needed
- These time constraints prior to audits results in CERs that are not sufficient
- CERs require weeks of extensive planning and updates, especially if they have not been updated to be Rev 4 compliant
- There is a tall learning curve for CER writers and the supporting cross-functional teams on the required inputs for a CER
- What was once sufficient is not anymore
- An evaluation of the clinical evidence will need to be performed as part of the process to ensure all device variants and indications are covered
- Where gaps exist, the Company will most likely need to initiate a PMCF study activity or the Company may consider (1) removing an indication from the labeling or (2) removing a device from the market
- Additionally, a review of the clinical evidence will need to be reviewed to assess if any new risks should be considered in the current risk documentation
- THESE THINGS TAKE TIME
- There is also the MDR requirement that all Class I reusable surgical instruments, which were devices that were self-certified under the MDD, will now need a CE certificate prior to May 2020 to remain on the market (e.g., Class I reusable surgical instruments)
The folks at EMERGO have provided a link to relevant documents.
Waiting Is Not an Option
Regulatory consultants we talked to all say the same thing: DON’T WAIT AND SEE. If you’re not ready, you are at risk of losing market share. Not surprisingly, they also say to call your device consultants.
