A: There is indeed a lack of notified bodies, with 20 at the moment. Bear in mind, the notified bodies went through a redesignation process from the MDD to the MDR, so some are still going through the process with relevant competent authorities in order to be designated under the MDR. If you Google “EC NANDO” it will give you the list of notified bodies that are available to certify under the MDR. There also are the MDCG codes that have been released in the document 2019/14. You will be able to assess the notified body, whether they can actually carry out work on your particular device family. Go to the EC’s website to check on the approved or certified notified bodies and then you can approach them, and they will be able to help you from there.
The second part of the question about it’s the expertise of the notified bodies – they are going through a re-designation process. They are going to be assessed according to the requirements and if they have the resources to do it. Some of the notified bodies have set up new teams in order to carry out work under the MDR. I have no doubts that if they are on the NANDO list and if your device family is listed, then yes, they will be able to carry out the assessment for you without a problem.
A: This is a very hot topic when it comes to combination products & the need for a CER. Now the GSPRs themselves, you have to make sure you are compliant with your clinical data. Now, let’s look at it this way. What is a CER? The CER is how the manufacturer demonstrates that the device that they’ve got on market, or coming to market, is compliant to the essential requirements under the GSPRs under the MDR. You need to use clinical data. By demonstrating compliance to the GSPRs using clinical data, it is a form of clinical evaluation, but it doesn’t need to be in the format that we know as a clinical evaluation report.
If you were to ask me, do you need a clinical evaluation report when you are demonstrating your GSPRs for an article 117 notified body opinion? The straight answer will be no. However, you must make sure that your GSPRs are compliant, and you must demonstrate that with clinical data. Clinical data also comes in many ways, it’s either from a clinical investigation, post-market surveillance, or from a scientific literature review, which you get in a clinical evaluation report. So, you don’t need to draft it as a clinical evaluation report in that sense, but by demonstrating compliance to your GSPRs, using clinical data, and having that clinical evidence, you are compliant to the requirements and that’s what you need to do.