MDCG Position Paper on extension period for legacy devices

The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative consequences for health systems and patients, the Council found new solutions to avoid an emergency.

On December 9, 2022, the Council agreed to various additional measures to implement the Medical Devices Regulation (MDR). Specifically, the new actions foresee:

• Extension of the transitional period based on the risk class of the device.
• Extension of the validity of certificates issued under the Directives on medical devices and active implantable medical devices.
• Removal of the “sell off” provision

The Medical Device Coordination Group (MDCG) promptly published a Position Paper, the “MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate”.

Common approach to extended validity of certificates for legacy devices

This MDCG Position Paper describes how the Competent Authorities intend to deal with devices whose certificates issued under the Directives expire before the new MDR certificate. Primarily, the position paper addresses only legacy devices, namely devices that fall within the scope of Article 120 of the MDR. It does not refer to certificates which were withdrawn or suspended. Additionally, the position paper does not address devices which have undergone a significant change in design or intended purpose.

The Competent Authority (CA) that deals with the below process is the CA of the EU country where the manufacturers or their authorised representatives have their place of business.

Assessment of safety by the Competent Authority

Assessing whether or not a device is subject to such extensions occur through following steps:

1. Manufacturers, or their authorised representatives, should inform the Competent Authorities of their respective EU country about non-compliance with the MDR. In this case, the expired certificate issued under the Directive and the lack of an MDR certificate represent a non-compliance.

2. After that, the Competent Authority should evaluate whether the device presents an unacceptable risk to the health or safety of patients, users or other persons. To assess potential risks to health and safety, the manufacturer should submit a report with data from the post-market surveillance system (PMS). Notably, the report should include data on incidents, serious incidents and field safety corrective actions.

3. The CA will take its decision, which is based on:

• Vigilance or market surveillance data or other information received.
• Vigilance or market surveillance data to which they have access.
• Information from the relevant notified body submitted by the manufacturer. In particular, audit reports with information about potential safety-related shortcomings from the last surveillance audit and their resolution.

If the CA considers the non-compliant device does not present an unacceptable risk to health and safety, article 97 on Other non-compliance applies. A written communication from the CA to the manufacturer follows. In this case, manufacturers must apply MDR requirements applicable to “legacy devices”. Especially, they must comply with legacy requirements concerning PMS, vigilance, and market surveillance. Furthermore, manufacturers should demonstrate that their Quality Management System (QMS) complies with MDR requirements.

Derogation and further CA intervention

Following this decision of the CA, no additional derogation related to to Article 59 MDR is necessary.

However, if any new information proves that the devices could represent a risk to health and safety, the CA can terminate the above-mentioned article 97 and apply article 95. Article 95 describes Procedure for dealing with devices presenting an unacceptable risk to health and safety.

Conditions for extended validity of certificates

The above described provision can apply only under certain conditions. Most importantly, these extensions can apply only when the manufacturer has already undertaken reasonable efforts to solve this non-compliance. More specifically, for these provisions to apply

• A notified body must already have accepted the manufacturer’s application for a new certificate.
• There must already be a written agreement signed by notified body and manufacturer.

Nonetheless, the CA can waive this condition mentioned above in the following circumstances:

1. The manufacturer is a SME (small and medium-sized enterprise).
2. The SME manufacturer has a certificate issued by a notified body not (yet) designated under the MDR.
3. The SME manufacturer can prove that they have already applied to many notified bodies, but their application was rejected due to the limited capacities of the notified bodies.

In accordance with article 97, the CA will determine a reasonable time given to the manufacturer to bring their devices into compliance. Usually, this period is at most 12 months but could be extended when duly justified. Among others, the manufacturer must inform the CA about any delays when bringing their devices into compliance.

Labels, sharing of information, and FSCs

In the context of the application of these provisions, the manufacturer should not change anything on the labels of the devices. Moreover, the manufacturer should inform distributors and importers about the non-compliance with the certificate and the related time to bring the device into compliance. If appropriate, the CA can also request to inform the users about the non-compliance.

Concerning Free Sales Certificates, CA can issue FSC. However, the validity cannot exceed the period set to bring the device into compliance with the MDR.

 

You can find all position papers and other relevant documents in our Library of Documents!