22 technical documentation according to Annexes II and III must also be taken into account in this context. All of this (and more) must be kept in mind when placing medical devices on the market or when a public authority announces its intention to audit the documents. However, those who have marketed “non-critical” devices for many years or even decades – typically devices in Risk Class I – may perhaps tend to adopt a somewhat laissez-faire attitude when faced with regulatory reform. But doing so might lead to a situation in which the new classification rules in Annex VIII are inadequately considered, and that the device may no longer be assigned to Class I at all. Rule 11 is likely the most prominent example of higher classification, as it states that virtually all medical software must be now classified in at least Class IIa. The official guidelines only list a few exceptions – including software or apps to support the desire to have children – as Class I software. The situation with “simple” seawater nasal sprays is similar, as they are now considered devices that are “composed of substances” under Rule 21 and are therefore placed in a higher class. Moreover, even products that are used to sterilise medical devices are classed as medical devices in their own right. So this certainly warrants a cautious approach. After all, however manageable the change may initially appear, it has serious implications for the companies involved. Because a higher classification... • means the need for a Notified Body for certification, • means mandatory implementation of a QM system according to ISO 13485, • means auditing and re-certification, • means higher personnel expenses, • may mean PMCF activities, • means PSUR, • may create stasis in further developments, ... and so on. Proof is demanded increasingly as well, including material testing vis-à-vis cleaning or disinfection processes, transport validation, a biological evaluation according to the new ISO 10993-1, updating of the clinical evaluation based on the new MDCG guidelines and in regard to usability. On top of that, it is essential to bear in mind the obligations of the aforementioned Person ENGLISH
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