MDR CONTRACT CONFIRMATON LETTER Subject: Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. This letteris the official document of UDEM A.§., a Notified Body (NB) designated in accordance with Regulation (EU) 2017/745 (MDR) and identified in NANDO with the number 2292, in accordance with the first subparagraph of Chapter 4.3 of Annex VII of the MDR and confirms that UDEM A.§. has received an application and has signed a written contract in accordance with the second subparagraph of Chapter 4.3 of Annex VII to the MDR with the following manufacturer: The devices covered by the above-mentioned official application and written contract are defined in the tables below. Table 1 describes the devices for which an MDR application has been received, a written contract has been made and UDEM A.§. is also responsible for the appropriate surveillance of the relevant devices within the scope of the 93/42/EEC Medical Device Directive (MDD). Table 2 identifies devices for which an MDR application has been received and a written contract has been concluded, but for which UDEM A.§. has not yet taken appropriate surveillance responsibility for the relevant devices under the MDD. For devices covered by certificates issued under the MDD which expire after 26 May 2021 and before 20 March 2023 without withdrawal, this letter also confirms that the manufacturer has provided evidence that the competent authority of the Member State under the MDR up to the date of expiry of the MDD certificate has granted an exception or exemption from the applicable conformity assessment procedure in accordance with Article 59(1) of the MDR or Article 97(1) of the MDR for the devices concerned until 20 March 2023. The transition timelines that apply to the devices covered by this letter, subject to the manufacturer's continued compliance to the other conditions specified in Article 120(3c) of MDR (as amended by (EU) 2023/607), are shown below: UDEM ULUSLARARASI BELGELENDiRME DENETiM EGiTiM MERKEZ1 SAN. VETiC. A.$. Mutlukent Mahallesi 2073 Sokak (Eski 93 Sokak) No:10 Umitkoy pankaya/Ankara

MDR CONTRACT CONFIRMATON LETTER • 31 December 2027 for Class III devices and Class lib implantable devices excluding Well-established technologies (WET - sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors) • 31 December 2028 for class lib devices other than those covered above, class lla devices and class I devices placed on the market in a sterile condition or with a measurement function, • 31 December 2028 for devices for which the conformity assessment procedure in accordance with Directive 93/42/EEC does not require the...

MDR CONTRACT CONFIRMATON LETTER UDEM Table-1 The Devices Covered in the Scope of this Letter and for which UDEM A.§. is Responsible for the Appropriate Surveillance of the Related Devices within the Scope of the UDEM ULUSLARARASI BELGELENDiRME DENETiM EGiTIM MERKEZi SAN. VETiC. A.$. Mutlukent Mahallesi 2073 Sokak (Eski 93 Sokak) No:10 Omitkoy Cankaya/Ankara 0(312) 443 03 90 [email protected]