Vastuskiri

Dear Jessica,

Thank you for your enquiry.

Unfortunately, the distribution notification can be only done through Estonian Medical Device Database (EMDDB, https://msa.sm.ee/).

For actors outside of Estonia we can make an account manually, so it is possible to log into the database with username and password. For creating an account we need a contact person’s full name, e-mail and the position in the company. Therefore, does the account go to your name?

Documents with the notifications of medical devices are following: Declaration of conformity, EC certificate, instruction for use in English, instruction for use in Estonian and copy of the labelling or packaging.

Also, please use a short guide for using the Estonian Medical Device Database that can be found on database homepage under „Forms“.

NB! Please note that the access to the database is limited to users outside of Estonia.

In case of this, please contact with [email protected] with an request to access to the database and your IP address. They will white-list your IP and you should have an access to the database.

This is a temporary restriction for security reasons which hopefully will be removed in near future.

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear team,

Please find below information for registering the non-Estonian manufacturer Synopsys (Northern Europe) Ltd. and the software-only product Simpleware ScanIP Medical for the Estonian market:

Name and address of person responsible for placing a product on the Estonian market, responsible for distribution or put into service in Estonia:

Synopsys (Northern Europe) Ltd.

Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom

[email protected]

+44 (0)1392 428750

Contact: Jessica James, [email protected]

The name and address of manufacturer of medical devices and, if applicable the name and address of authorised representative in the EU;

Manufacturer:

Synopsys (Northern Europe) Ltd.

Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, United Kingdom

[email protected]

+44 (0)1392 428750

Authorised representative:

Synopsys International Ltd.

Blanchardstown Corp Park, Block 1, Dublin 15, Ireland

[email protected]

353-1-436-8800

Name and intended purpose of the device in Estonian and English:

Simpleware ScanIP Medical

Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or an MRI scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options. Simpleware ScanIP Medical is not intended to be used for mammography imaging.

Simpleware ScanIP Medical on ette nähtud kasutamiseks tarkvaraliidesena ja pildisegmentimise süsteemina kujutisandmete

ülekandmisel meditsiinilisest skannerist, nagu kompuutertomograafist või magnetresonantstomograafist, väljundfaili. See on ette

nähtud kasutamiseks ka tarkvarana kirurgiliste ravivõimaluste simuleerimisel/hindamisel enne operatsiooni. Simpleware ScanIP

Medical pole ette nähtud kasutamiseks mammograafias

https://www.synopsys.com/content/dam/synopsys/simpleware/pdfs/simpleware-scanip-ifu-2022-03_estonian.pdf

Identification of the device (commercial name of the device, model or catalogue number):

Simpleware ScanIP Medical

Software-only device, covering versions:

O-2018.12

P-2019.09

Q-2020.03

Q-2020.06

R-2020.09

R-2021.03

S-2021.06

T-2022.03

Please let me know if any of this information is unclear, or if any more information is needed.

Best,

Jessica

Jessica James, PhD
Quality Management Representative, Simpleware Software​
w +44 (0)1392 428752 | [email protected]

www.synopsys.com | Bradninch Hall, Castle Street, Exeter, EX4 3PL, UK