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The EU-MDR Article 16 No. 2 provide some guidance which should be considered here: .... the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements: (a) provision, including translation, of the information supplied ...

​Dear audience, Marocco requires a CeMin marking since the 1st February 2020 - does anybody know if it is also required for electrical medical devices? I found the two scources telling the following: 1. Marking CeMim compulsory on electrical products and toys, pursuant to orders no.-2573-14 ...

Dear Al, please have in mind: SCOPE AND DEFINITIONS Article 1 Subject matter and scope: 4.For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred ...

Thanks Nicole, perfect link! BR Frank​ ------------------------------ Frank Wilmerstaedt General Manager QA/RA Wentorf bei Hamburg Germany ------------------------------

​Hi RapsCom, does anybody has information who issues free sales certificates for medical devices in france? Best regards ------------------------------ Frank Wilmerstaedt General Manager QA/RA ------------------------------