Directive 90/385/EEC as amended (AIMDD) relating to active implantable medical devices and Directive 93/42/EEC as amended (MDD) relating to medical devices

Directive 90/385/EEC as amended (hereinafter, AIMDD) and Directive 93/42/EEC as amended (hereinafter, MDD) are repealed with effect from 26 May 2021 following the application of Regulation (EU) 2017/745 (hereinafter, MDR), without prejudice to the information and notification obligations regarding certificates, vigilance, clinical investigations, registrations of device and economic operator, for which the provisions of the AIMDD and MDD continue to apply until EUDAMED is fully functional.

The Regulation (EU) 2023/607 amending the MDR as regard to transitional provisions for certain medical devices entered into force on 21 March 2023.

Here below, a brief summary of the transitional provisions of Article 120 of the MDR as amended by Regulation (EU) 2023/607:

Article 120 (2), 2nd subparagraph, of the MDR: Extension of the validity of AIMDD and MDD certificates

Certificates issued by Notified Bodies in accordance with AIMDD or MDD from 25 May 2017 that were still valid on 26 May 2021 and that have not been withdrawn afterwards shall remain valid until:

(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) above, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

Certificates issued by Notified Bodies in accordance with AIMDD or MDD from 25 May 2017 that were still valid on 26 May 2021 and that expired before 20 March 2023 shall be considered to be valid until the aforementioned dates only if at least one of the conditions set out in Section 120 (2), 2nd subparagraph, of the MDR is fulfilled.

Article 120 (3) of the MDR: Extension of the transitional period

Devices with a certificate issued in accordance with AIMDD or MDD and valid by virtue of Article 120 (2) of the MDR are allowed to be placed on the market or to be put into service until the above-mentioned dates only if the conditions set out in Article 120 (3c) of the MDR are met.

Devices for which the conformity assessment procedure pursuant to MDD did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to MDR requires the involvement of a notified body are allowed to be placed on the market or to be put into service until 31 December 2028 only if the conditions set out in Article 120 (3c) of the MDR are met.

Article 120 (3e) of the MDR: Responsibility for appropriate surveillance

Until 26 September 2024, the responsibility for the appropriate surveillance of the Device with a certificate issued in accordance with AIMDD or MDD and valid by virtue of Article 120 (2) of the MDR remains in charge of the Notified Body that issued such certificate, unless the Manufacturer transfers the responsibility for such surveillance to another Notified Body designated under the MDR.

In any case, as from 26 September 2024, the responsibility for the appropriate surveillance of the Device with a certificate issued in accordance with AIMDD or MDD and valid by virtue of Article 120 (2) of the MDR shall be taken on by the Notified Body (designated under the MDR) with which the Manufacturer has signed a contract (pursuant to section 4.3, 2nd subparagraph, of All. VII of the MDR) for the conformity assessment under the MDR of such Device or a Device intended to replace it.

In both the above cases, the arrangements for transferring of the appropriate surveillance shall be clearly defined in a written agreement between the manufacturer, the Notified Body designated under the MDR and, where possible, with the Notified Body that issued the AIMDD or MDD certificate.

Article 120 (4) of the MDR: Deletion of the “sell-off” deadline

Devices lawfully placed on the market pursuant to AIMDD or MDD before the end of the transitional period may continue to be made further available on the market without a legal time restriction.

More information is available at: New Regulations (europa.eu), section “Extension of the transition periods provided for in the regulations”

IMQ as Notified Body

IMQ S.p.A is Notified Body under AIMDD and MDD.

Terms and conditions related to the appropriate surveillance performed by IMQ S.p.A. in accordance with Article 120 (3e) of the MDR are described in the “IMQ Regulation for EC Certification of active implantable medical devices pursuant to Directive 90/385/EEC as amended (AIMDD) and of medical device pursuant to Directive 93/42/EEC as amended (MDD)”

IMQ S.p.A. is Notified Body for the MDR: Medical Devices (MDR) - Regulation (EU) 2017/745 - IMQ.

For further information and/or to request IMQ a customized offer for MDR certification, please contact us by filling in the "Contact Us" form or by writing to medicali@imq.it

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