LOTRIČ Metrology Ltd.
Basically, face masks can be
divided into three major groups: protective masks (FFP masks), medical face
masks and personal face masks. For the EU market, except for personal masks, masks
must conform to the legal framework requirements and must be marked with CE
before being placed on the market. LOTRIČ Metrology performs medical mask tests
in accordance with EN 14683:2019+AC:2019. In addition to the end products, we
also test materials intended for the manufacture of masks in the development
phase. LOTRIČ Metrology is a Notified body number 2897 for Personal Protective
Regulation - PPE (EU) 2016/425.
We have been calibrating and testing, with
a love for metrology, for three decades. LOTRIČ
Metrology is a family business with more than 170 staff members. LOTRIČ
Metrology as a group consists of 10 companies operating in Slovenia, Germany,
Austria, Croatia, Bosnia and Hercegovina, Serbia and N. Macedonia. Our
certificates are present in 49 countries around the world, mainly in Central
and Eastern Europe, where we provide 24-hour response to more than 21.000
customers. For most clients, we cover 95% of their metrology needs. In the year
2020, we performed 97.612 calibrations and tests.
face masks on the EU market must be certified in accordance with the Medical
Devices Regulation - MDR (EU) 2017/745. The harmonized technical standard for medical
face mask is EN 14683:2019+AC:2019.
face masks are, in accordance with the Medical Device Regulative, a risk class
I, except for masks that are sterile packaged, which are class Is. For risk
class I, the manufacturer does not need a Notified body, but according to
module A of the Regulative, manufacturers can make the conformity assessment themselves.
the manufacturer must meet all regulatory requirements and needs: a quality
system (ISO 14385 quality management for medical devices is preferred); a risk
management (ISO 14791 application of risk management to medical devices is
preferred); all necessary tests performed according to EN 14683 and the requirements
of the Regulation related to Health and Safety requirements; technical
documentation and adequate marking, labelling and packaging, with instructions
and a Declaration of conformity.
The legal framework for face masks is set down in two Regulations, and
after the requirements are fulfilled by the manufacturer, a CE mark can be
applied. The certification process shall be repeated in the required period,
while the manufacturing process shall be permanently in accordance with all