Küsimused

Dear Sarah Hamed,

Thank you for your enquiry.

Updating already notified medical device documents or changes and keeping them continuously updated is not required by law. However, the device distribution notification requirement itself remains and some of the changes you listed may require a change notification if the device can no longer be regarded as the same as originally notified.

In practice, this mainly concerns the dataset provided in the notification (e.g., manufacturer/authorised representative name, device name, REF number). Supporting documentation should accompany the update, but the required documentation package depends on the nature of the change. For example, if the device REF number changes or new REF numbers are added, we would expect a complete set of device documents to be submitted that reflects that.

We do not expect to receive updates about minor changes, e.g., packaging or shelf-life changes etc., that only reflect in the accompanying documentation and not in the dataset notified.

The notification itself can be made through the Medical Devices and Appliances Database (https://msa.sm.ee/), where the initial notification was submitted. In case of changes, the profile of the specific device should be opened and under “New application” the relevant application can be selected to update the device entry (for example, „Correct data“ to change device name/intended purpose/REF numbers).

Do not hesitate to contact me should you require any additional information or have further questions.

Best regards,

Karl Kalev Türk
Specialist

Department of Medical Devices

State Agency of Medicines

[email protected]

1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140

www.ravimiamet.ee

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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. 1. Which documents must be submitted,

2. 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