The German Federal Institute for Drugs and Medical Devices (BfArM) has specified on its website the provisions for this special route, which follows Recommendation (EU) 2020/403 from March 13. The article is only available in German – should you require further details, please don’t hesitate to get in touch.
In a recent article, we have indicated to a special authorization of certain medical devices and PPE urgently required in the current COVID-19 crisis, e.g. face masks and surgical masks.
Face masks according to the Medical Devices Directive (MDD)
Manufacturers may follow the general test principles according to EN 14683:2019 and apply for the special authorization by providing the corresponding reports. It is important to mention that this procedure does not permit manufacturers to affix the CE mark on their products or sell their devices on the market claiming compliance to the PPE Regulation (EU) 2016/425.
Face masks according to the PPE Regulation
Products of this type – typically filtering face piece (FFP) masks – would normally require certification by a Notified Body before placing them on the market. Recommendation (EU). If no certificate is available or marketability in the USA, Canada, Australia or Japan cannot be proven, manufacturers may follow test principles according to EN 149:2001 and apply for a special authorization by providing the corresponding test reports.
Notified Bodies, for example bsi, have incorporated the new provisions as per Recommendation (EU) 2020/403 in their business practice and offer various routes for manufacturers to comply with the requirements. The corresponding article is available in German – should you require additional details, please let us know.
Sources: BfArM and bsi
Accompanying this subject we recommend the following content on our website
- Browse our website by keyword European Commission.
- Visit our Complete Library Section.
- Read or article “Guidance on MD and PPE in times of COVID-19 and local provisions“.
- Read our article “European Commission Recommendation on Regulatory Exemptions for COVID-19 Products“.