MDR transition extension

On 15 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of European Union.

Only a day later, the European Commission published a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

The main takeaways:
The extension applies to medical devices and in vitro diagnostic medical devices which had a valid EC certificate at the date of publishing the Regulation (EU) 2023/607 (15 March 2023), which, according to the extension, may be placed on the market or put into service until the following dates:

(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), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function. The same deadline applies for devices that are class I (non-sterile, without measurement function) under MDD, but for which a notified body will be necessary under MDR.

The MDR classification is used for the determination of the extension deadline.

For the extension to be applied, several prerequisites need to be met. As was the case previously, the devices must continue to be subject to the notified body audits, and there must not be any significant change, but two new requirements are given:

• no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with MDR Article 10(9);
• no later than 26 May 2024, the manufacturer or the authorized representative has lodged a formal application with a notified body, and, no later than 26 September 2024, the notified body and the manufacturer have signed a written agreement.

One important peculiarity is that the responsibility to conduct audits confirming compliance of the device with MDD (and the quality management system of the manufacturer with MDR Article 10(9)) falls on the notified body with which a contract for MDR was signed.

The sale-off period was removed, and all the devices (both medical and in vitro diagnostic devices) placed on the market by December 31 2027/2028 (depending on the class), may continue to be on the market without any deadline.

Parallel MDD and MDR certificates
The manufacturers can keep (if they want to) their MDD certificate for the same device for which the MDR certificate was already issued, until the aforementioned deadlines, if the prerequisites for keeping the MDD certificates are met, and in this case, both MDD and MDR audits shall be conducted.

What if you don’t want to apply for an MDR certificate?
For manufacturers who do not wish to apply for an MDR certificate, the transition period ends on May 26^th 2024.

What about expired certificates?
Certificates that have expired before the entry into force of the Regulation 2023/607 (i.e. 20 March 2023) shall only be considered valid if

• either before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement 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,
• or a national competent authority has granted a derogation in accordance with Article 59(1) MDR or has required the manufacturer, in accordance with Article 97(1) MDR, to carry out the applicable conformity assessment procedure within a specified period of time.

How can a manufacturer demonstrate that its device is compliant with the requirements for transition extension?
As previously defined, notified bodies cannot issue new MDD/AIMD certificates after May 26^th 2021. Therefore, a question arises how can a manufacturer demonstrate that its EC certificate is still valid?
The Commission lists three possibilities:

1. The manufacturer can issue a self-declaration confirming that a particular device and manufacturer’s QMS are compliant with all the requirements of Regulation (EU) 2023/607.
2. Notified bodies can issue a “confirmation letter” stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Such confirmation should clearly identify the devices covered by the extension and certificates concerned. Such confirmation letter could be based on a harmonized template and be issued, in principle, without extra costs.
3. Competent authorities can issue free sales certificates, for the duration of the extended certificate validity.

How Salus Cons can help you?
Salus Cons is a consulting company, specializing in medical devices and in vitro diagnostic devices. We can help you with the transition to MDR and IVDR by participating in the adaptation of your QMS and the technical documentation for your devices.