I am a Netherlands-based manufacturer or this manufacturer’s authorised representative. If I choose to register an actor and product for Class I medical devices and IVD in EUDAMED, will I also be required to submit a notification via NOTIS in order to comply with national legislation?
No. The government recognises information on Class I medical devices and IVD registered in the EUDAMED modules that have been launched. There is no need for double registration. See also the EU position paper.