MDCG publishes position paper on the application of Article 97 MDR to legacy devices
In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR), a device may be placed on the market only if it complies with the requirements of the MDR. MDCG 2022-18 „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“ aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 MDR in those situations is meant to be a temporary solution. 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.
If certification of devices under the MDR has not been finalised before expiry of the Directive’s certificate, and where the device does not present an unacceptable risk to health and safety, Article 97 MDR enables competent authorities to require the relevant manufacturer, or its authorised representative, to bring the non-compliance to an end within a reasonable and clearly defined period. This will ensure that the conformity of the devices concerned is established as soon as possible under the conditions set by the competent authority, while limiting as much as possible the impact on the supply of safe and effective devices to patients and healthcare providers.
The mechanism described in MDCG 2022-18 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.