The NAMMDR issues, upon request, out-of-scope notices regarding the inclusion of some products under the definition of “medical device”.
Out-of-scope notices are not issued for all products (which are not medical devices) authorised for circulation on the EU market.
Out-of-scope notices are issued upon request if the applicant is unsure of the inclusion of some products in the category of “medical devices” 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.)
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.
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 “Medical devices > Forms and fees – Medical devices”.
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.
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 “Medical devices > Medical devices legislation > Laws, ordinances and government decisions – Medical devices > Orders of the Minister of Health”.
In line with Order of the Minister of Health no. 1356/2013, Annex 1, point 2, a 60-lei fee is required for issuance of an out-of-scope notice.