The NAMMDR issues, upon request, out-of-scope notices regarding the inclusion of some products under the definition of \u201cmedical device\u201d.<\/p>\n
Out-of-scope notices are not issued for all products (which are not medical devices) authorised for circulation on the EU market.<\/p>\n
Out-of-scope notices are issued upon request if the applicant is unsure of the inclusion of some products in the category of \u201cmedical devices\u201d or if the out-of-scope notice is required to be forwarded to an authority (in order to complete customs procedures, to clarify some issues related to auctions, etc.)<\/p>\n
In order to issue an out-of-scope notice, the applicant submits to the NAMMDR the forms “Request for issuance of an out-of-scope notice” and “Form for payment of the out-of-scope notice” filled in with the requested data and accompanied by the specified documents.<\/p>\n
The application form for issuing a denial and the form for payment of the out-of-scope notice is available for download in the section \u201cMedical devices > Forms and fees \u2013 Medical devices\u201d.<\/p>\n
In the “Request for issuing an out-of-scope notice” form, a single product or a single category which includes several products with the same classification criteria will be specified.<\/p>\n
The procedure for issuing out-of-scope notices is described in Order of the Minister of Health no. 2242\/2022, available online in the section \u201cMedical devices > Medical devices legislation > Laws, ordinances and government decisions \u2013 Medical devices > Orders of the Minister of Health\u201d.<\/p>\n
In line with Order of the Minister of Health no. 3467\/2022, Annex 1, point 1.2, a 120-lei fee is required for issuance of an out-of-scope notice.<\/p>\n","protected":false},"excerpt":{"rendered":"
The NAMMDR issues, upon request, out-of-scope notices regarding the inclusion of some products under the definition of \u201cmedical device\u201d. Out-of-scope […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":469,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4786","page","type-page","status-publish","hentry"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4786","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/comments?post=4786"}],"version-history":[{"count":3,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4786\/revisions"}],"predecessor-version":[{"id":9665,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/4786\/revisions\/9665"}],"up":[{"embeddable":true,"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/pages\/469"}],"wp:attachment":[{"href":"https:\/\/www.anm.ro\/en\/wp-json\/wp\/v2\/media?parent=4786"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}