GE 5160986-2 - Page 13

Page 13
March 2022
Medical Device
MDR 2017/745
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the product is a
medical device.
CE Mark
MDR 2017/745
MDD 93/42/EEC
Annex XII
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the product
conforms with applicable
requirements set forth in
MDR 2017/745 or MDD
93/42/EEC for conformity
assessment.
Authorized
Representative
in the
European
Community
ISO 15223-1,
Symbol 5.1.2
MDR 2017/745
/ MDD
93/42/EEC
ISO 15223-1: Medical
devices - Symbols to be
used with medical device
labels, labelling and
information to be supplied
- Part 1: General
requirements
REGULATION (EU)
2017/745 OF THE
EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 5
April 2017 on medical
devices, amending
Directive 2001/83/EC,
Regulation (EC) No
178/2002 and Regulation
(EC) No 1223/2009 and
repealing Council
Directives 90/385/EEC and
93/42/EEC
Indicates the Authorized
Representative in the
European Community
Authorized
representative
for Switzerland
Swiss Medical
Devices
Ordinance Art.
51 para. 1
N/A
Indicates the authorized
representative in
Switzerland
Chinese
Environmental
Symbol
SJ/T 11364
equivalent to
2011/65/EU
(EU/RoHS 2)
China RoHS Standard SJ/T
11364: Regulations for the
Labelling of the Use of
Restrained Hazardous
Substances on Electronic
and Electric Products
Indicates Chinese
‘Environmentally Friendly’
Period.