Profile

Dear Anon, If your device is a "combined product" which means single integral, not reusable and only to be used in this combination, you either need a Notified Body Opinion according to Article 117 of the MDR or just a signed GSPR checklist. You have to perform a virtual classification of your device ...

Dear May, An Authorized Representative is not required for this type of products, so the MAH can deal directly with a Notified Body. In my experience (so far we helped obtaining 14 Notified Body Opinions) Notified Bodies required the docments that provide objective evidence that the device meets ...

Dear Anon, As part of an ISO 13485 the auditor is required to verify that there is an adequate procedure in place which meets the requirements of section 7.3 of the standard. Furthermore he / she is required to verify that you work according to this procedure and create the records as defined (by the ...

Hello Bob and Richard, Me again. Thanks to Richard for the additional input regarding standalone "non-integrated" drug delivery devies such as syringes and pumps. Just to be very clear: a syringe is only regulated as a medical device if it's placed on the market like that (empty syringe) - if it's ...

Dear Bob, This is correct. The Notified Body assesses the technical documentation of the manufacturer / MAH and, if all applicable requirements of Annex I (General Safety and Performance Requirements) are met, issues a Notified Body Opinion (NBOp). Unless there are significant changes, this is a one ...