I, the undersigned, GIUSEPPE PREZIOSA, who was born in S.

FERDINANDO DI PUGLIA (BT-

Italy) on 24/05/1946 and whose address is Via A. BERTOLONI n. 12/1, ZOLA PREDOSA (BO-
Italy), acting as LEGAL REPRESENTATIVE of the company SIARE ENGINEERING
INTERNATIONAL GROUP SRL with headquarters in Via G. PASTORE n. 18, VALSAMOGGIA-
Crespellano (BO-Italy), Tax Code and VAT nr. 03851731202, being aware that, in case of false
declarations, shall be prosecuted with criminal sanctions pursuant to articles 75 and 76 of D.P.R.
28.12.2000 n. 445, and with sanctions according to Penal Code and to special laws in the context
of false deeds and declarations pursuant to articles 46 and 47 of D.P.R. n. 445/2000

HEREBY DECLARE

that in compliance with

- article 120 of REGULATION (EU) 2017/745 concerning Medical Devices and
- REGULATION (EU) 2023/607 amending REGULATION (EU) 2017/745 and (EU) 2017/746 as
regards the transitional provisions for certain medical devices and in vitro diagnostic medical
devices
“Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC
from 25 May 2017that were still valid on 26 May 2021and that have not been withdrawn afterwards
shall remain valid after the end of the period indicated on the certificate until the date set out in
paragraph 3a of this Article applicable for the relevant risk class of the devices. Certificates issued
by notified bodies in accordance with those Directives from 25 May 2017that were still valid on 26
May 2021and that have expired before 20 March 2023shall be considered to be valid until the
dates set out in paragraph 3a of this Article only if one of the following conditions is fulfilled:
a) before the date of expiry of the certificate, the manufacturer and a notified body have signed a
written agreement in accordance with Section 4.3, second subparagraph, of Annex VII to this
Regulation for the conformity assessment in respect of the device covered by the expired
certificate or in respect of a device intended to substitute that device;
b) a competent authority of a Member State has granted a derogation from the applicable
conformity assessment procedure in accordance with Article 59(1) of this Regulation or has
required the manufacturer, in accordance with Article 97(1) of this Regulation, to carry out the
applicable conformity assessment procedure.”;

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
Capitale Sociale € 100.000,00 Int. Vers.
 3a
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:
a) 31 December 2027, for all class III devices, and for class IIb implantable devices except
sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires,
pins, clips and connectors;
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.

Medical Devices produced and distributed by Siare Engineering International Group Srl are
compliant with REGULATION (EU) 2017/745 with transition period taken into account.
Moreover, Siare Engineering International Group Srl ensures compliance with the obligations
deriving from REGULATION (EU) 2017/745.
More specifically:

 After-Sale Surveillance (Articles from 83 to 86, Art. 92 and Attachment III)

 Vigilance (Articles from 87 to 92)
 Economic Operators Registration (Article 31)

This declaration is valid until the deadlines set out in REGULATION (EU) 2023/607.

Crespellano – Valsamoggia, date: May 4, 2023

Giuseppe Preziosa
Legal Representative
Siare Engineering International Group Srl

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
Capitale Sociale € 100.000,00 Int. Vers.