Kiri

Thank you for a quick response!

Br,

Richard Krantz

Specialist Post Market Quality

Nordics

Dear Richard

Thank you for your inquiry!

There is no requirement under the Estonian Medical Device Act for a handwritten signature from the customer who has received a Field Safety Corrective Action (FSCA) or Field Safety Notice (FSN).

Only requirement for an FSN is stated in § 27.  Registration of adverse incident and field safety notice:

(2) The field safety notice is drawn in Estonian with regard to medical devices made available on the Estonian market. Initial field safety notice submitted for an urgent situation may also be in English.

The key requirement is that the manufacturer can demonstrate that the customer has received and understood the FSCA or FSN. This can be achieved through various forms of electronic confirmation, such as emails, electronic signatures, or acknowledgment forms on a website.

What is crucial is that there is documented evidence showing that the customer has acknowledged receipt and understanding of the Field Safety Notice or corrective action.

If you have any further questions, please feel free to contact us.

Kind regards

Hi!

Is there a requirement for a handwritten signature from the customer or does some form of electronic confirmation work just as well when collecting response forms from customers who have received Field Safety Corrective Actions (FSCA) and Field Safety Notifications (FSN)?

Br,

Richard Krantz

Specialist Post Market Quality

Nordics

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