Questions and Answers Regarding the MDR Extension

On March 20, 2023, the Regulation (EU) 2023/607 of the European Parliament and Council of March 15, 2023, was published in the Official Journal, amending the articles related to the transitional period of Regulations (EU) 2017/745 and (EU) 2017/746.

In response to some unresolved points, on March 28, 2023, a guideline of questions and answers was issued to clarify any uncertainties as much as possible.
The following follows the guideline and does not aim to delve into the details of Regulation (EU) 2023/607. To understand its content, it is necessary to know the details of the MDR extension.

For which Medical Devices is the Transition Period Extended?

The extension of the transition period applies only to legacy devices that are intended to be adapted to MDR. In this case – and provided that the necessary conditions to benefit from the extension are met – the transitional period extends beyond May 26, 2024.

Legacy devices that are not intended to be certified under MDR and whose certificate expires between March 20, 2023, and May 26, 2024, can benefit from the extension of the transition period until May 26, 2024.

Does the MDR Certificate Automatically Revoke the MDD Certificate?

No. The legacy device and its corresponding MDR device can be placed on the market in parallel until the end of the relevant transition period. The notified body can revoke the MDD certificate only if the legislative requirements are no longer met or if the certificate should not have been issued.

How to Define the “Device Intended to Replace the Legacy Device”?

The MDR device may undergo changes in design and intended use compared to the respective legacy device it’s replacing. It’s up to the manufacturer to determine and justify the link between the MDD device and the MDR device.

Which Classification Rule is Considered to Define whether the Transition Extends to 2027 or 2028?

The classification rules observed are those provided in Annex VIII of the MDR. In cases where there is a change in risk class when transitioning from MDD to MDR, the class indicated on the certificate may differ from the class that determines the extension of the transition period. However, when determining the applicable MDR requirements (for example: in relation to the PSUR), the established class is that of the MDD.

What Happens to Custom-Made Devices?

The new regulation addresses the transition period for class III implantable custom-made devices, the only ones among custom-made devices requiring the intervention of a notified body. For this category of devices, if the prescribed deadlines are met, the transition period extends until May 26, 2026.

What Happens if the Certificate Expired before March 20, 2023?

In this case, the medical device can benefit from the extension (regardless of any national derogations or laws) only if:

• Before the certificate’s expiry date, a written agreement was concluded between the manufacturer and the body for the conformity of the device covered by the expiring certificate and the device intended to replace it.
• A national competent authority has granted an extension to carry out the conformity procedure within a specific time frame.

How to Demonstrate that the Legacy Device Benefits from the Extension of the Transition Period?

Once the requirements are met, the possibility of benefiting from the extension is automatic by law. However, it can be useful and necessary to have a document attesting to the extension of the certificate’s validity for the devices of interest. Two possibilities are indicated:

• Manufacturer’s self-declaration;
• Confirmation letter issued by the notified body attesting to the receipt of the application and the conclusion of the written agreement, at no additional cost.

What Elements are Necessary for the Formal Application?

For devices with certificate expiry after March 20, 2023, it is necessary to submit the certification application (formal application) by May 26, 2024. At this stage, the documentation to be provided is only that necessary for the written agreement. The manufacturer then agrees with the body on the deadline for submitting the specific and complete technical documentation.

What Elements are Necessary for the Written Agreement with the Notified Body?

For devices with certificate expiry after March 20, 2023, it is necessary to sign the written agreement with the notified body no later than September 26, 2024. During the written agreement, an indication of the possible date for submitting the complete technical documentation, not provided during the formal application, is included.

How to Demonstrate the Implementation of a QMS According to MDR?

By May 24, 2024, the manufacturer must establish a quality management system (QMS) according to MDR.

When applying for certification, the manufacturer must provide the necessary documents on the topic of surveillance: PMS, market surveillance, vigilance, and registration. The assessment of the entire quality management system will be considered by the notified body later, during certification activities.

What Happens if the Written Agreement with the Notified Body is Signed before March 20, 2023?

If the application and/or written agreement were made before March 20, 2023, the application remains valid and it is not necessary to execute a new written agreement.

What Elements are Necessary for Transferring Surveillance from the MDD Body to the MDR Body?

A tripartite agreement is concluded between: manufacturer, MDR body, and where applicable, MDD body. In particular, the non-involvement of the MDD body can only be considered if the notified body is no longer able to sign the contract (example: cessation of activity).

In general, the agreement provides for the transfer of documentation from the outgoing body to the incoming body. The following points should be emphasized regarding the transfer of surveillance to another notified body:

• It occurs even if the MDR notified body was not notified under MDD;
• The MDR notified body does not take responsibility for the declaration of conformity but limits itself to surveillance;
• If there are appropriate justifications, the new notified body can revoke the MDD certificate.

The MDD notified body remains responsible for surveillance at the latest until September 26, 2024 (or earlier, if agreed as such).

What Happens, in Case of a Change of Body, to the Body’s Identification Number on the Label?

Unless otherwise indicated in the “tripartite agreement”, the legacy device can be placed on the market and put into service with the MDD body’s number, even if surveillance is delegated to the MDR notified body.

Who Benefits from the Removal of the “Sell-Off” Date?

For those devices that benefit from the transition, the expiry date for making available on the market has been removed. In particular, devices placed on the market before or during the transition period can continue to be made available on the market or put into service without limitations.