Fees Group VIII

Type	Description	Euros
8.01	Procedure of special declaration for cosmetics products	507,71
8.02	Procedure of individually registering and authorising personal care products and disinfectants	507,71
8.03	Procedure for registering and recording medical devices	105,10
8.04	Procedure for modifying and validating personal care products and disinfectants	176,92
8.05	Procedure for Certificate issuing	153,82
8.06	Procedure of verification and control of the statement of compliance for the manufacturing of cosmetics and personal care products	746,20
8.07	Procedure of verification and control of the statement of compliance for the importation activity of cosmetics and personal care products	384,64
8.08	Procedure of verification and control of the statement of compliance for modification in the manufacture activity of cosmetics and personal care products	384,64
8.09	Procedure of verification and control of the statement of compliance for modification in the importation activity of cosmetics and personal care products	176,92
8.10	Individual inspection activities to verify the statement of compliance	746,20
8.11	Procedure of authorisation of confidentiality of cosmetic ingredients	507,71
8.12	Procedure of preliminary operating licence for medical devices and disinfectants: manufacturing establishment, systems and procedure packs manufacturing establishment	746,20
8.13	Procedure of preliminary operating licence for medical devices and disinfectants: import establishment	384,64
8.14	Procedure of modification of preliminary operating licence for medical devices and disinfectant establishments in relation to facilities location: manufacturing facilities, Systems and procedure packs manufacturing facilities	746,20
8.15	Procedure of modification of preliminary operating licence of medical devices and disinfectant facilities in relation to facilities location: import establishment	384,64
8.16	Procedure of modification of preliminary operating licence procedure for medical devices and disinfectant establishments	176,92
8.17	Procedure of revalidation the licence of medical devices and disinfectant establishments: manufacturing establishment	538,48
8.18	Procedure of revalidation of the licence of medical devices and disinfectant establishments: importing establishment	330,79
8.19	Authorisation for clinical research of medical devices	840,80
8.20	Assessment report on medicinal products incorporated into medical devices	1.538,54
8.21	Assessment of “CE” mark certification files for medical devices within the same family according to full quality assurance system procedure	2.560,26
8.22	Assessment of “CE” mark certification files for medical devices according to EC type examination procedure, combined with production quality assurance, EC verification or product quality assurance	923,12
8.23	Assessment of “CE” mark certification files for medical devices within the same family, through EC declaration of conformity combined with production quality assurance, EC verification or product quality assurance	769,28
8.24	Verification of products and batches of products	239,51
8.25	Assessment of “CE” mark certification files for medical devices according to EC design examination	1.692,40
8.26	Initial audit in accordance with full quality assurance system	3.363,23
8.27	Initial audit in accordance with production quality assurance	2.795,69
8.28	Initial audit in accordance with product quality assurance	2.241,80
8.29	Follow-up audits and certification extension audits	2.241,80
8.30	Audits on additional premises and repeat audits	1.121,43
8.31	Change to administrative details on “CE” mark certification	153,82
8.32	Extensions to “CE” mark certifications	153,82
8.33	Procedure of modifications of medical devices	63,06