In accordance with Regulation (EU) 2023/607 dated March 20, 2023, changes regarding the dates on which medical devices with a certificate within the scope of the 93/42/EC Medical Device Directive can be placed on the market or put into service have entered into force.
In accordance to the (EU) 2017/745 Medical Device Regulation (MDR) Article 120 “Temporary Provisions”, Regulation (EU) 2020/561 and Regulation (EU) 2023/607, certificates issued in accordance with 93/42/EEC Directive from 25 May 2017 by SZUTEST Conformity Assessment Inc. that still were valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid after the end of the period indicated on the certificate until the dates set out in MDR Article 120(3a) for the relevant risk class of the devices.
Certificates issued by SZUTEST Conformity Assessment Inc. in accordance with 93/42/EEC Directive from 25 May 2017 that were still valid on 26 May 2021 and that have expired before 20 March 2023 shall 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.
In the light of the information given above, the certificate validity dates have been extended as stated below in accordance with Article 120 (3) of the Regulation (EU) 2017/745.
(3a) 31 December 2027, for class III devices and for class IIb implantable devices, except sutures, ataples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
(3b) 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.
Devices referred to in paragraphs 3a and 3b of this Article may be placed on the market or put into service until the dates referred to in those paragraphs only if the following conditions are met:
(a) those devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
(b) there are no significant changes in the design and intended purpose;
(c) the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
(e) no later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application with a notified body in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3a and 3b of this Article or in respect of a device intended to substitute that device, and no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement of Annex VII.
Class I devices that do not require a Notified Body’s assessment of the conformity assessment procedure; devices for which the declaration of conformity was issued prior to 26 May 2021 and for which the conformity assessment procedure pursuant to MDR requires the involvement of a Notified Body, may be placed on the market or put into service until 31 December 2028.
For the purpose of Article 120(3a) MDR, which provides for the new transitional periods depending on the device’s risk class, the classification rules laid down in Annex VIII to the MDR apply. In certain cases, where the classification rules of the MDR result in a different risk class, the device’s risk class indicated on the certificate may differ from the risk class that determines the end date of the transitional period.
However, where during the transitional period the risk class of a device is needed to determine applicable MDR requirements (e.g. in relation to PSUR), the class of the device is the one established in accordance with the MDD classification rules.
SZUTEST Conformity Assessment Inc. shall apply the requirements of the MDR on post-market surveillance, market surveillance and audit, vigilance, registration of economic operators and devices in place of the requirements corresponding to the Medical Device Directive 93/42/EEC to these devices.
Until 26 September 2024, unless the manufacturer agrees with a notified body assigned under the MDR that it will carry out the surveillance assessment, SZUTEST Conformity Assessment Inc. shall continue to be responsible for the necessary surveillance audit for all applicable requirements of 93/42/EEC provided that there is no significant change in the design and the intended use of the devices it has certified. This assessment shall also cover unannounced audits.
Not later than 26 September 2024, the notified body that has signed the written agreement referred to in subparagraph (e) of MDR Article 120 (3c) shall be responsible for the surveillance of devices covered by the written agreement, if specified in the agreement. Where the written agreement covers a device intended to replace a device with a certificate issued under Directive 93/42/EEC, surveillance is carried out according to the device to be replaced (under the existing certificate).
Surveillance assessments upon the request of the certified manufacturer; arrangements regarding the transfer from SZUTEST Conformity Assessment Inc to the notified body appointed under the MDR; where applicable; the manufacturer is clearly defined in an agreement between the notified body appointed under the MDR and SZUTEST Conformity Assessment Inc. The notified body appointed under the MDR is not responsible for the conformity assessment activities carried out by SZUTEST Conformity Assessment Inc.
Manufacturers certified by SZUTEST Conformity Assessment Inc. shall submit their applications for the transfer of surveillance assessments to the SZUTEST Conformity Assessment Inc. Sales Unit with the FR.MED.201 Application Form for Transferring Surveillance Assessments in order to benefit from the time extension for the transition period.