Manufacturer attestation of EC Certificate extension
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districlass medical sa Sales Office / Sales Office: 110, AII6e Louis LSpine - 69970 CHAPONNAY - France Phone : +33 (0)4 72 50 43 75 Fax : +33 (0)4 72 50 43 67 Email: districlass@districlass.com Subject: Extension of the CE marking of medical devices of the DistricAth® range Pursuant to Article 1 paragraph 1 of Regulation (EU) 2023/607 of March 15th 2023 amending Article 120 of Regulation (EU) 2017/745, Districlass Medical SA may place on the market class III implantable medical devices " DistricAth® Ti" and "DistricAth® Ti/PSU" until December 31st 2027. CE certificate n°33451 rev4 of the " DistricAth® Ti" devices and the CE certificate n°8432 rev8 of the "DistricAth® Ti/PSU" devices issued on January 12th 2021 by the GMED notified body in accordance with Directive 93/42/EEC expired on March 13th 2022. However, pursuant to paragraph 3bis, those certificates shall remain valid after the end of the period indicated on the certificates until December 31st 2027 because the following conditions laid down in paragraph 3quater are met: • Such devices shall continue to comply with Directive 93/42/EEC. • There is no significant change in design and intended use. • The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or taking into account other aspects of the protection of public health. • The notified body verified during an on-site audit in October 2022 that Districlass Medical SA has implemented a quality management system in accordance with Article 10 paragraph 9 of Regulation (EU) 2017/745. Certificate No. 8447 rev18 of compliance with the requirements of NF EN ISO 13485:2016 of the quality management system developed by Districlass Medical SA was renewed on January 13th 2023 for a period of three years following this audit. • Districlass Medical SA has signed a written agreement with the GMED for the conformity assessment of the above-mentioned devices according to Annex VII, Section 4.3, second paragraph of Regulation (EU) 2017/745 dated February 19th 2021 before the expiry date of the certificates. Districlass Medical SA hereby undertakes to ensure compliance with these conditions of application of Regulation (EU) 2023/607 throughout the transition period until December 31st 2027. Siege social / Headquarters. 10, RuePayUBerr 4200a^AITH-rT rtLNptf^Franc SASiiu tipita’ de Eg! Jacques BERTHEAS PRESIDENT

Official Journal of the European Union REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof, Having regard to the proposal from the European Commission, After transmission of...

Official Journal of the European Union Also due to the impact of the COVID-19 pandemic, the transitional period provided for in Regulation (EU) 2017/746 was already extended by Regulation (EU) 2022/112 of the European Parliament and of the Council (9). Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC...

Official Journal of the European Union Article 120(4) of Regulation (EU) 2017/745 and Article 110(4) of Regulation (EU) 2017/746 prohibit the further making available on the market or putting into service of devices which are placed on the market by the end of the applicable transitional period and which are still in the supply chain one year after the end of that transitional period. To prevent the unnecessary disposal of safe medical devices and in vitro diagnostic medical devices that are still in the supply chain, thus adding to the imminent risk of shortages of such devices, such...

Official Journal of the European Union (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.’; (b) paragraph 3 is replaced by the following: ‘3. By way of derogation from Article 5 and provided the conditions set out in paragraph 3c of this Article are met, devices referred to in paragraphs 3a and 3b of this Article may be...

Official Journal of the European Union No later than 26 September 2024, the notified body that has signed the written agreement referred to in paragraph 3c, point (e), of this Article shall be responsible for the surveillance in respect of the devices covered by the written agreement. Where the written agreement covers a device intended to substitute a device which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, the surveillance shall be conducted in respect of the device that is being substituted. The arrangements for the transfer of the...

Official Journal of the European Union Article 3 Entry into force This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Strasbourg, 15 March 2023. For the European Parliament The President R. METSOLA For the Council The President J. ROSWALL