Profile

Hi, the certification agreement between the manufacturer and the notified body originally signed years ago under the MDD must in allmost allcases be updated, because it this agreement does NOT cover the grace period during which no MDD notified bodies exist any more. We understand, that the new certification ...

Dear Spyros, what I tried to explain is the new MDR initial conformity assessment process which is different from the MDD conformity assessment we are all familiar with since more than 25 years. Keep also in mind, that between 2 to 4 different people are involved in technical file reviews today ...

Hi, to summarize our discussion: there is no general obligation that distributors and importers must be certified by a notified body. But if a distributor or an importer change the intend prupose of a device already placed on the market or put into service or modifies a device already placed on the ...

Dear Tiina, to my understanding article 16 does not destinguish between different risk classes. This means to me, if a distributor or importer is doing these specific activities even on class I devices only, he needs a certificate issued by a notified body. ------------------------------ Klaus-Dieter ...

Hi, establish a sampling plan, sample technical documentation(s), assess technical documentation(s) and assess the quality system documentation are all tasks BEFORE a notified body goes on-site for a quality managment system audit. There is not too much wihich goes parallel and this process in the ...