Good day,
To answer your questions:
1. Yes, an AR can represent you as a company to a Competent Authority - though they should have the regulatory knowledge, experience with your device, and understand the situation including any classification rationales. An AR can be the liaison between the Manufacturer and the Competent Authority in matters of post market, requests for technical documentation information, and other regulatory assistance. But you are right an AR typically acts more in a post market role than a premarket role. Though you as the Manufacturer can work with a Competent Authority directly, you do not need to go through an AR. In fact, in cases of classification where the Notified Body can not assist, then it may be beneficial to go directly to a Competent Authority.
2. I am not sure you will find specific guidance from an NB on exact process of classification. I have never seen one. Though we have a nice supposed process as part of the new EU MDR where the MDCG group will help coordinate regulatory status and classification of products (including so-called borderline products) through Expert Panels and technical working groups. Logically the process should be confirm with Notified Body first on classification, then either they (the NB) or you escalate to a Competent Authority. The EU MDR should make this process more distinct, but there is not yet any guidance on this process. In the future, it should go NB, then CA, then MDCG, then Expert Panel, then maybe technical working group, back to Expert Panel, back to MDCG, back to CA, back to NB, back to Manufacturer. In the end, depending on the novelty of the device, there might even be a new Common Specification. And as you can imagine this process is going to take a long time - so good luck getting new, novel devices on the market in the EU. Also a comment: do not ask the NB/CA what is the classification. Go to them with a clear regulatory strategy for your device including classification and rationale behind your justification for classification including Rule. What you want to achieve is them agreeing with your approach.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Feb-2020 15:11
From: Anonymous Member
Subject: ARs, NBs, and classification review
This message was posted by a user wishing to remain anonymous
Hello,
I work at a startup with a novel device for which classification review is a high priority. We recently secured a Notified Body. One of our partners involved in our development process is adamant that we need to secure an Authorized Representative (AR) right away. They say that ARs can represent us (the manufacturer) to the Competent Authority for classification review. In my experience, ARs typically provide post-market support mainly around vigilance, incident reporting, recalls/FSCAs, etc. I know they can provide extra services such as labeling review, standards compliance guidance, etc, but I have never heard of (or seen any written material) regarding an AR assisting with manufacturer representation for classification review. I thought that NBs were the primary partner for premarket activities in the EU.
Questions:
1. Is it true that ARs can represent manufacturers to the CA (and that this is beneficial for the manufacturer)?
2. What are best practices for how to prepare for the NB classification review for a novel device? We have not yet received specific guidance from the NB on the exact process. We have an upcoming meeting scheduled with the Technical Rep. but it would be good to get feedback on this forum as well.
Thank you.