Vastuskiri

Dear Marija Capek,

Thank you for your enquiry.

The classification of the medical device is the responsibility of the manufacturer. Estonian manufactures and authorised representatives can turn to us when they have questions related to classification or when seeking information, but as a norm we do not make classification decisions for actors. There is no additional fee for a consultation with us.

Manufacturers can find relevant guidance documents on the European Commission’s web-page,  https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en , to assist the manufacturer with the classification.

Additionally, according to the Regulation (EU) 2017/745, article 51 (2), any dispute between the manufacturer and the notified body concerned, arising from the application of Annex VIII, shall be referred for a decision to the competent authority of the Member State in which the manufacturer has its registered place of business. In cases where the manufacturer has no registered place of business in the Union and has not yet designated an authorised representative, the matter shall be referred to the competent authority of the Member State in which the authorised representative referred to in the last indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered place of business. Where the notified body concerned is established in a Member State other than that of the manufacturer, the competent authority shall adopt its decision after consultation with the competent authority of the Member State that designated the notified body.

Best regards,

Egle Audova

Chief Specialist

Department of Medical Devices

Phone +372 5566 7596

[email protected] | [email protected]  

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Dear Sir or Madam ,

could you please let me know the procedures for requesting the classification of a medical device, the approximate processing time of a request for classification of a medical device and also the fees that apply?

Thank you, best wishes,

Marija Capek

Quality First International

[email protected]