Considering the COVID-19 pandemic there is a huge and increasing need of ventilators to be used in particular with most critical patients.
Respirators are classified as medical devices according to the following:
- Class IIa – if they are non-invasive devices not intended for intensive care
- Class IIb – if they are invasive and intended for intensive care
Being class II medical devices the involvement of a notified body is mandatory in order to affix the CE mark.
Given the great demand for these products, an European guideline on how to make the ventilators available on the European market has been published (https://ec.europa.eu/docsroom/documents/40941).
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