There are two types of EU legal Frameworks applicable are:

1. Regulation (EU) 2016/425: For face mask as PPE
2. Regulation (EU) 2017/745 (superseded from Council directive 93/42/EEC): For medical gloves, surgical masks, intensive care & other medical equipment that come under the scope of EU legal framework on medical devices.

Face Mask Type	Regulation	Standard	NB Involvement	Testing Required
Surgical masks	Regulation (EU) 2016/425	EN 14683	Not Needed	By Independent Lab
Face masks	Regulation (EU) 2017/745	EN 149+ EN 14683	In Design Examination	By NB Laboratory

Applicable EU Standards

1. Under PPE, any technical solution may be used by manufacturer to meet the essential requirement.
2. For Face Masks,
   1. EN 149:2001+A1:2009 for FFP Type mask
   2. EN 14683:2019 for Surgical Type mask