EuMDR technical documentation Review Frequency

SHrine

Registered
Hello all,
We are a manufacturer of a Class IIa (EU) product that received CE mark under the euMDR in Aug of 2022. We only have one device and as a result, one set of technical documentation. MDCG 2019-13 (Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation) section 4.1.2 states that "In cases where the certificate contains very few devices and the technical documentations of these have been already reviewed, it is expected that during surveillance audits the notified body will focus on the review of the technical documentation related to post-market surveillance in accordance with Annex III". Our interpretation is that only during the on-site audit will the PMS portion of the technical documentation be re-reviewed. The guidelines are also clear with terminology differentiation 'audits' vs 'assessment' (technical documentation). However here we are, a year later undergoing another full day off-site assessment. When discussing concerns with the NB it was stated that this would only be 1/2 day to review changes to the technical documentation (there have been none) and the PMS. The PMS was just reviewed during our on-site audit in May. The technical documentation assessor informed us that this 1/2 day review has now been extended to one day to basically re-review the full documentation. I am very curious if anyone else has has experience with this. I believe the NB is intentionally misinterpreting the MDGC guidelines.
Thoughts?
 

Raisin picker

Quite Involved in Discussions
You NB obviously has too much free time. Our NB never assesses TD documentation outside of the regular certification (once per cycle). Unless there was some issue with the TD in the original assessment that requires some review later, e.g. to assess the results of an ongoing PMCF study that provided insufficient results at initial review. But then, this should have been mentioned in the initial TD assessment report.
 

SHrine

Registered
We 100% agree. During our initial push-back we were told this was only a 0.5 day review of the PMS. We answered and addressed all of of the assessors comments or questions. Our PMCF plan and CER was accepted as well. The assessor (in writing) told us that they are instructed that if the PMS takes less than a day they are to go looking for other potential issues, even if there is no change. At least two of the questions are repeated where I have had to point out to the assessor that this was already addressed. The response is that we have to address it AGAIN. I am thoroughly disgusted as this feels like a money grab. The plan is to perform this same review annually. So much for the backlog of MDR files. Unfortunately there doesn't seem to be much recourse. We are meeting with another NB this morning.
 
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