Hello Anon,
It does vary a little from Notified Body to Notified Body (NB), so whichever one you are settling on - ask them the complete process. They should be clear and transparent in this process, including costs, per the regulation. The simple process is explained as Roisin did: initial contact, request for quotation, company application, contract/agreement signing, product specific application, scheduling, review/audit. Some NB combine the company application and product application in one step. So once they have an idea of all your products, then this is composed in the contract/agreement. Make sure you read and understand the contract carefully, because while there are the EU MDR/EU IVDR, NB add additional wording in the contracts. What you cited in Article 53 is really when the contract/agreement is signed between two parties. The regulation was written in order that companies did not pick-n-choose NBs for different products in the same company. You can have multiple requests for quotation and multiple applications in to NBs, but you should only be signing one contract/agreement. It might be a good thing to do, because we have heard the bad experiences where a company sent in request, received, sent in application, and months later the NB said they could not review their product. So they had to start all over again.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-May-2023 04:39
From: Roisin Slevin
Subject: MDR Application to NB
Hi
After initial discussions with a new Notified Body, the Notified Body will provide a Request for Quotation (RFQ) form to the manufacturer to complete. This application form requires details of the company and the product and the service required. The next step is for the NB to accept the manufacturer as a customer and issue a quotation and/or a contract agreement for the manufacturer to sign. The MDR application is a separate form and is specific to the classification of the device and requests the technical documentation specific to the product under review.
I hope this is helpful.
Kind regards,
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Roisin Slevin
Senior Regulatory Affairs Manager Premarket
Galway
Ireland
Original Message:
Sent: 30-May-2023 12:01
From: Anonymous Member
Subject: MDR Application to NB
This message was posted by a user wishing to remain anonymous
Hello,
I work for a company that is trying to find a new NB to get certified to MDR. However, I do not understand the application process. Is the MDR application different than a request for quotation? Is there a pre-application step that where information about the company/device(s)/services is submitted so that we can compare costs before committing to a Notified Body? Or is the application paperwork provided by the Notified Body the same application referred to in Article 53 of MDR, which states, "The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure."
Thank you.