Regulation (EU) 2023/607 (hereinafter: the "Amending Regulation"), amending Regulation (EU) 2017/745 on medical devices (hereinafter: the "MDR Regulation") and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter: the "IVDR Regulation"). was published in the Official Journal of the EU on March 20, 2023.
The main provisions of the Amending Regulation are:
- Extension of the transition period (MDR Regulation);
- Extension of the validity of certificates (MDR Regulation);
- Removal of the sell-off period (MDR Regulation and IVDR Regulation).
- Extension of the Transition Period
The Amending Regulation extends the transition period of the MDR Regulation, i.e., the date until medical devices certified under Directives 93/42/EEC (hereinafter: the "MDD Directive") and 90/385/EEC (hereinafter: the "AIMD Directive") may be placed on the market and put into service. This transition period applies under certain conditions and is determined by the class of the medical device.
In line with the preceding, devices certified in accordance with the MDD Directive or the AIMD Directive may be distributed as follows:
- all class III devices, and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors, until December 31, 2027;
- class IIb devices other than those covered by the point above, class IIIa devices, class I sterile devices, or such devices having a measuring function until December 31, 2028.
If the following conditions are met, the devices mentioned above may be placed on the market or put into service:
- the devices continue to comply with the MDD Directive or the AIMD Directive;
- there are no significant changes in the design and intended purpose;
- 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;
- no later than May 26, 2024, the manufacturer puts in place a quality management system;
- no later than May 26, 2024, the manufacturer lodges a formal application with a notified body for conformity assessment, and no later than September 26, 2024, the notified body and the manufacturer sign a written agreement regarding the conformity assessment.
- Extension of the Validity of Certificates
Certificates issued by a notified body under the MDD Directive or the AIMD Directive that were valid on May 26, 2021 (the application date) and have not been withdrawn shall remain valid after the expiration of the date indicated on the certificate until the extended deadline above, depending on the relevant risk class.
- Removal of the Sell-Off Period
According to the former MDR Regulation rules, a sell-off period is a limitation under which devices lawfully placed on the market before May 26, 2021, or from May 26, 2021, by the transitional rules, must be recalled and withdrawn after the expiration of the sell-off period, i.e., May 26, 2025.
Because the Amending Regulation removed this sell-off period from the MDR Regulation, medical devices placed on the market or put into service under the MDD Directive or the AIMD Directive may be distributed after May 26, 2021, without any sell-off period.
- IVDR Amendments
The Amending Regulation also eliminates the sell-off period from the IVDR Regulation. As a result, under the transition rules, in vitro diagnostic medical devices placed on the market in accordance with Directive 98/79/EC (hereinafter: the "IVDD Directive") may be distributed after May 26, 2022, without any sell-off period.
It is important to note that the Amending Regulation does not change the transition rules of the IVDR Regulation. The IVDR Regulation's governing transition regime was extended in 2022 and is still in effect.
According to the IVDR Regulation's transition regime, in vitro diagnostic medical devices with a certificate issued under the IVDD Directive may be placed on the market or put into service until the following deadlines:
- Class D devices until May 26, 2025;
- Class C devices until May 26, 2026;
- Class B devices and class A sterile devices until May 26, 2027.