mdi Europa has been contacted frequently throughout the COVID-19 crisis regarding regulatory requirements for surgical masks in Europe under Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 (MDR) on medical devices.
We have published several articles on this topic, which we list further down. Recently, the European Commission has published a guidance document for this product type. Manufacturers engaged in this field should have a closer look at the document. You can download the document from the website of the European Commission here.
Source: European Commission
Guarding the COVID-19 subject, we warmly recommend the following content on our website
- Read our article “Surgical and FFP masks in the COVID-19 crisis“.
- Read our article “European Commission gives details of how to prevent COVID-19 test failures“.
- Read our article “Guidance on MD and PPE in times of COVID-19 and local provisions“.
- Browse our content by keyword “COVID-19“.