A Class IIa device requires the involvement of a Notified Body (NB) in its conformity assessment procedure to determine whether the manufacturer and the device actually meet the legal requirements and the use of the device is therefore safe, efficient, and has more benefits than risks in total. Any technical documentation for a device in a risk category IIa or above is evaluated by a NB. Although such an inspection involves significant additional costs and puts considerable pressure on all participants, we are proud to say that we have succeeded in all our projects in recent years, and our technical documentation compiled as a part of our services has consistently complied with the requirements of NBs. However, it must be acknowledged that in many cases this does not happen for the first try. Such a process has myriads of unforeseen factors, for which it is difficult to prepare even in compliance with all the professional guidelines.

In our fictitious example, a manufacturer produces Class IIa devices which have been on the market for many years, but in order to extend the MDR transition period, we are entrusted with counseling service for re-certification under MDD in 2020, with special focus on the compilation of the clinical evaluation report. Thorough inspection of the technical documentation of the device revealed that not all contact materials were compiled; the manufacturer did not have its own biocompatibility test for the final product and the biocompatibility of the supplied raw materials were not credibly justified (according to these findings, the biocompatibility report of the device was considered non-compliant). Not only the MDR, but also the previous legal environment required compliance with the essential requirements to be verified, hence the verification of biocompatibility is sufficiently thorough only if the relevant ISO 10993 test(s) for contacting materials are available from an accredited laboratory. Despite the indicated gaps, manufacturers often stand by their opinion that their own assessments are correct, and they wish to defend their position despite any criticism received from the Notified Bodies. As consultants, we are always obliged to indicate if certain documents do not meet the legal requirements, but in such cases we strive to find the optimal solution. During the audit of the device, Notified Bodies shall carry out a thorough check of compliance with the general requirements and in case of any non-conformity, they will not accept the technical documentation. In our example, despite the efforts of the manufacturer, the lack of proof of biocompatibility was recorded as a non-conformity, so in the corrective, second round we were assigned with the preparation of the biological evaluation report as well. During the evaluation, we had to choose to abandon certain raw materials in order to be able to manufacture, certify and market the device without significant additional cost. It was not necessary to recall products previously placed on the market due to many years of distribution without unexpected adverse events. However, it had to be recorded in the PMS/PMCF activity that the manufacturer would monitor these products closely. In order to prepare for MDR, clinical data will be collected using devices made of certified biocompatible materials.