MDR: MDCG offers workaround for legacy devices with expiring certificates

The European Commission’s Medical Device Coordination Group (MDCG) has proposed steps to enable certain legacy devices to remain on the market if they have not been certified under the Medical Devices Regulation (MDR).
 
In a position paper published on 9 December, MDCG laid out a “uniform approach” to Article 97 of MDR, which it said can be used to enable devices with expired certificates issued under the previous directives to remain on the market. The position paper was published the same day the European Health Commissioner Stella Kyriakides proposed postponing the MDR transitional deadlines to 2027 and 2028, depending on the risk classification of the device. (RELATED: European Council members support proposal to delay MDR deadlines, Regulatory Focus 9 December 2022)
 
The group said that manufacturers have made “reasonable efforts” to comply with MDR, competent authorities may allow legacy devices that do not pose any unacceptable risk to patient health and safety and have not undergone significant changes to remain on the market despite their non-compliance with MDR.
 
“The mechanism described in this document provides for a legally sound, coherent, consistent and controlled period of the non-compliance of devices, which are impacted by the limited capacity of notified bodies and for which no unacceptable safety concerns are identified,” MDCG wrote.
 
Medical device makers and other stakeholders have raised concerns that due to a lack of notified bodies and other factors, thousands of medical devices may be pulled from the European market because they don’t conform to MDR.
 
MDCG’s position paper is a legal interpretation of Article 97 of MDR that was put in place specifically to avoid medical device shortages. The paper aims to reach a common understanding of the regulatory provision and develop a widely accepted approach to allow certain products to continue to be marketed while they work to get recertified.
 
“The use of Article 97 MDR in those situations is meant to be a temporary solution,” MDCG said. “It will contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients. This document should not be regarded as a commonly agreed solution for addressing the expected bottleneck of expiring certificates by 26 May 2024.”
 
MDCG said that manufacturers that are unable to meet the MDR deadline or their authorized representative, should proactively reach out to the competent authority of the member state where their product is registered to alert them of the situation.
 
The notice should detail when the certificate under the Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) is set to expire and whether the product poses an unacceptable risk to public health, along with relevant data gathered from their postmarket surveillance system (PMS). The group also said that the competent authority should look at product information submitted to relevant notified bodies from the manufacturer as part of their evaluation on whether the product qualifies for Article 97.
 
If the competent authority concludes that a product qualifies under Article 97, MDCG said that should not be a blank check to allow it to stay on the market indefinitely, but rather, a deadline to conform should be determined on a case-by-case basis. In most situations, the group said manufacturers should be required to comply with MDR within 12 months, though they can ask for additional time if needed.
 
“At any moment, based on new information that has come to its attention, the (competent authority) will be able to assess any potential emerging risk to health and safety in relation to the device concerned,” MDCG added. “Where the (competent authority) finds that, on the basis of such new information, the device presents an unacceptable risk to health and safety, it should terminate the application of Article 97 MDR and apply Article 95 MDR.”
 
For a product to be eligible to remain on the market under Article 97, the manufacturer should have already undertaken steps to transition their product to MDR requirements, including by getting their conformity assessment accepted by a notified body; however, MDCG said there are times when that may not be feasible. In such situations, MDCG recommends that the competent authority waive the requirement if the manufacturer is a small- and mid-sized enterprise (SME), the MDD or AIMDD certificate was issued by a notified body that has not yet been designated under MDR, and the manufacturer can show that despite their good faith efforts their product has not been certified due to a lack of available notified bodies.
 
MDCG position paper