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/EEC 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 notified bodies. that still were valid on 26 May 2021 and that have not been withdrawn afterward shall remain valid after the end of the period indicated on the certificate until the dates set out in MDR Article 120(3a) for the relevant risk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 notified bodies 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.

Within the information given above, the certificate validity dates have been extended as stated below in accordance with Article 120 (3a) of Regulation (EU) 2017/745.

(a) 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;

(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.

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.

Until 26 September 2024, unless the manufacturer agrees with SZUTEST Konformitätsbewertungsstelle GmbH that it will carry out the surveillance specified in Article 120(3d), MDD Notified Body shall continue to be responsible for the necessary surveillance assessment 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. These surveillance assessments shall also include unannounced audits.

Not later than 26 September 2024, SZUTEST Konformitätsbewertungsstelle GmbH 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).

SZUTEST Konformitätsbewertungsstelle GmbH 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.

Surveillance assessments upon the request of the MDD certified manufacturer; arrangements regarding the transfer from MDD Notified Body to the SZUTEST Konformitätsbewertungsstelle GmbH; where applicable; shall be clearly defined in an agreement between the manufacturer, SZUTEST Konformitätsbewertungsstelle GmbH and MDD notified body. SZUTEST Konformitätsbewertungsstelle GmbH is not responsible for the conformity assessment activities carried out by MDD notified body

If the manufacturer wants to make an application to the SZUTEST Konformitätsbewertungsstelle GmbH, the manufacturer shall apply for transferring of surveillance assessment with the FR.MED.01 Annex 4-Information Related to Transfer of Surveillance Assessments Form and relevant annexes to SZUTEST Konformitätsbewertungsstelle GmbH until 26 May 2024.
If the application is approved, SZUTEST Konformitätsbewertungsstelle GmbH and the manufacturer shall sign FR.MED.90 (EU) 2017/745 Product Conformity Assessment Agreement which is specified as in MDR Article 120 (3c)(e), no later than 26 September 2024. Regarding to this agreement, the FR.MED.203 Confirmation Letter shall be published by SZUTEST Konformitätsbewertungsstelle GmbH and the manufacturer shall publish”Manufacturer Declaration”.

SZUTEST Konformitätsbewertungsstelle GmbH looks forward to working with you in completing the MDR transitions on time.

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