Saatja: Hamed, Sarah [VISEU Non-J&J] <
[email protected]>
Saaja: RA MSO
Teema: MD change notification in Estonia
Dear Sir or Madam
I am a Regulatory Affairs professional at J&J supporting the registration and compliance of medical devices in the EU.
I would like to understand the post-registration change requirements in Estonia for changes such as:
* Manufacturer or authorized representative address/name changes
* CE certificate revisions (quality management or technical documentation)
* Declaration of Conformity revisions
* IFU or labeling updates (content, format, or translation)
* Packaging or shelf-life changes
* Product discontinuation
If any of these changes are subject to notification, could you please advise:
1. Which documents must be submitted,
2. Through which portal or submission channel
Thank you very much for your assistance in clarifying this matter. This will help ensure that we are fully aligned with Estonian regulatory requirements.
Best regards,
Sarah Hamed