On 20 March 2023, Regulation 2023/607 was finally published in the Official Journal of the European Union EUR- Lex, which formalises and makes immediately enforceable the extension to 2027-2028 of the transition period provided for in Article 120 MDR (EU) 2017/745.
This extension facilitates companies and bodies, such as Notified Bodies, in the transition from MDD to the new Regulation and aims to avoid blockages or difficulties in the delivery of treatments.
The overall goal of the proposed amendment is to maintain patients’ access to a wide range of Medical Devices while ensuring the transition to the new framework and allowing Medical Devices that have already been placed on the market and still available to remain on the market.
To whom is this MDR extension addressed?
Please note that the MDR extension is only valid for Legacy Devices, i.e. those that require or will require the intervention of a Notified Body. On the other hand, for Class I Devices (in self-declaration) that will remain as such, the MDR is already fully applied since 26 May 2021.
What are the new transition periods?
Regulation 2023/607 stipulates that Medical Devices covered by EC Certificate or EC Declaration of Conformity AIMDD or MDD drawn up prior to 26 May 2021 and not yet expired may be placed on the market or put into service until:
– High-risk class devices, i.e. Class III Medical Devices and Class IIb implantable Medical Devices, except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors:
- The transition period is extended from 26 May 2024 until 31 December 2027.
– Medium and Low risk classes devices, i.e. Class IIb, other than those indicated in the previous point, Class IIa, Im, Is and Ir Medical Devices:
- The transition period is extended until 31 December 2028.
– Class III implantable custom-made devices with the application of the manufacturer for a conformity assessment carried out before 26 May 2024:
- The transition period is extended until 26 May 2026.
Regarding to Medical Devices whose Certficates expired before 20 March 2023 benefit from the above extension only if:
- 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, for MDR (EU) 2017/745 certification, in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
- The competent authority has intervened in one of the following two ways::
- It has granted a derogation for the Manufacturer in accordance with Article 59(1) of MDR (UE) 2017/745;
- It has made an assessment in accordance with Article 94 of MDR (EU) 2017/745 and – following the conclusion that the Device did not entail any unacceptable risk – implemented the measures under Article 97.
The Regulation confirms that the application of the extended transition period is subject to several conditions that must occur at the same time, namely:
- Device must continue to comply with Directive 90/385/CEE or Directive 93/42/EEC, as appropriate;
- Device must not be subject to significant changes in the design and intended purpose;
- The devices must not present an unacceptable risk to the health or safety of patients, users or other persons;
- no later than 26 May 2024, the manufacturer has put in place a quality management system MDR-compliant system;
- No later than 26 May 2024, the Manufacturer or the Authorised Representative must lodge a formal application for MDR certification, and, no later than 26 September 2024, the Notified Body and the Manufacturer must sign a written agreement.
There are currently no explanatory MDCG guidelines for the Regulation, although interpretative and applicative doubts still remain on some crucial aspects.
The extension further extends the application time of MDR (EU) 2017/745, but the situation continues to be rather complex and changeable.
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