Declarations of Conformity

Effective March 1st, 2019, attempts of registering Declarations of Conformity for Class I medical devices will, by mandate , require applicants to receive auto -generated unique application numbers in advance for use with subsequent physical deliveries thereof in original plus Turkish translation copies bearing notary attestation alongside original copies bearing an Apostille stamp. Since Class I devices fall in the low -risk category by contents in their composition , they constitute the only class for which EC certification is not sought . Declarations of Conformity submitted for Class I products , however, MUST incorporate references to Annex VII of the Directive 93/42/ EEC. The PTS does not provide a specific expiry date field for Declarations of Conformity . However , if any DoC issue is subject to a date of expiry or has a terminal date of validity, this has to be specified in the respective field in the PTS titled expiry date.