Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.

Recently, I have come across a manufacturer of IIa MD who claims that they launch their products without prior NB approval provided that the given MD is within the scope of the Full Quality Assurance certificate already issued, i.e., if the certificate was issued, let’s say, for catheters and they have developed a new catheter model, they can CE-mark the product and freely market it.

Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity, and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls, and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.

I went through the MDD several times and it seems that it depends on the interpretation of your NB. Do you agree?

Thanks in advance for the discussion.