Date: 18th May 2023

Dear Sir,

We, M/s. Siare Engineering International Group S.r.l. who are established and reputable
manufacturer of “ICU Ventilators & Anesthesia Machines” having factories at Via Giulio Pastore, 18
– Località Crespellano - 40053 Valsamoggia (BO) Italy do hereby declare that the latest version of
our 93/42/EEC MDD certificate here enclosed is expiring on 26/5/2023.

Anyway, the 93/42/EEC Medical Device Directive has been repealed and replaced by new 2017/745
Rule (MDR) and we count to get MDR certification by September 2023.

Therefore, in order to allow you to use our CE certificate after its expiry date, we enclose a
Declaration dated 4/5/2023 extending CE certificate’s validity to 31/12/2028 by virtue of
REGULATION (EU) 2023/607 to allow transition to MDR certification to those companies who have
applied for it.

In this attached declaration (Dich conformità MDR con period transitorio EN.pdf) we make reference
to REGULATION (EU) 2023/607 which postponed the application of REGULATION (EU) 2017/745
(MDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic
medical devices.
The Regulation (EU) 2023/607 certifies that: Devices which have a certificate that was issued in
accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph
2 of this Article may be placed on the market or put into service until the following dates:
b) 31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for
class IIa devices, and for class I devices placed on the market in sterile condition or having a
measuring function.

For the moment, you could use the enclosed file “Dich conformità MDR con periodo transitorio EN.pdf
” which extend validity of CE certificate.

In any case, on 26/05/2023 our Notified Body KIWA Cermet SpA will issue an official declaration
referred to the above EU 2023/607 Regulation to further strengthen and formalize the above
extention. We will send it to you as soon as we get it.

Should you need further information, please, feel free to contact us.

Kindest Regards

Siare Engineering International Group S.r.l.

SIARE ENGINEERING INTERNATIONAL GROUP SRL P.iva-Cod. Fisc. 03851731202 Internet: www.siare.it
Unipersonale
Tel. +39.051.96.98.02 E-mail: mail@siare.it
Via Giulio Pastore, 18 Località Crespellano
C.C.I.A.A. (BO) REA 551149 PEC: siaresrl@cert.database.it
40053 VALSAMOGGIA (BO) Italy
Capital Sociale € 100.000,00 Int. Vers.