Emergo’s blog and EUDAMED.eu Richard Houlihan have announced that specific portals of the postponed European EUDAMED database will made available prior to the officially published May 2022 date of implementation:
- Actor registration: March 2021
- UDI/Device: May 2021
- Certificate/Notified Body: May 2021
Even without knowing whether data entry will be voluntary or mandatory 1st quarter next year, if these dates are accurate for module implementation, the medical device industry and all associated actors, need to get into 6th gear to ensure compliance.
Please note: NO official announcement from the European Commission confirming these details is currently available.
For what purpose has the EC “leaked” this information? This situation is very similar to the original EUDAMED postponement 7 months ago when during a Medical Device Forum meeting, a cavalier announcement from a committee member caused multiple repercussions around the regulatory world. It would be a week following that single comment before any official communication was issued by the EC or MDCG.
Why is this process not transparent? Multiple rumours, unsubstantiated statements, and speculation does very little to support a smooth MDD to MDR transition for industry, competent authorities, and all key stakeholders.
The EUDAMED database and related compliance activities may be implemented earlier than previously expected. Now is the time for regulatory operations teams to engage with their cross-functional colleagues to determine when and how they will implement the regulatory data requirements within their business.
During these extremely challenging times of the COVID-19 crisis, regulatory teams are continuing to struggle uphill to support business compliance. Do not allow a lack of technology keep you at sea level.
Please contact me at KimYoung@instem.com for additional information on software solutions for EUDAMED data.