Medical devices: Information on consultation procedures, registration of guideline products and registration deadlines published
Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding the exemption provisions to this procedure, an interpretative document has been published. Devices under the directives (AIMDD, MDD, IVDD) may be placed on the market, made available on the market or put into service after the date of application of the respective regulation under certain conditions. Article 120, paragraph 3 of the MDR and Article 110, paragraph 3 of the IVDR regulate, among other things, that the registration of the directive products in the European Database for Medical Devices (Eudamed) must be carried out in accordance with the respective applicable regulation. For this purpose, a document has been published that contains more detailed information on the registration of guideline products. According to Article 29 of the MDR, the registration of the products in Eudamed has to take place. With regard to the deadlines for the registration of products, inconsistencies arise from the text of the MDR. Therefore, a clarification of the applicable deadlines was made.Further information on these publications can be found on the following BASG website: https://www.basg.gv.at/medizinprodukte/mdr-ivdr/aktuelles-zu-mdr-ivdr/
