The article provides an overview of the guidance document explaining how Article 97 MDR should be applied to legacy devices.
Table of Contents
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the application of Article 97 of the Medical Devices Regulation 2017/745 (MDR) to legacy devices for which the certificates issued under the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive (AIMDD) expire before the respective certificates are issued under the new regulatory framework. The document is intended to provide additional clarifications regarding the applicable regulatory requirements and recommendations to be taken by all the parties involved to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding in their nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, it is explicitly stated that the present guidance does not constitute an official EC document and should not be considered as representing an official position of the authority.
First of all, it is stated that 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. Furthermore, it is stated that under Article 52 MDR, manufacturers shall undertake an assessment of the conformity of the device in accordance with the applicable conformity assessment procedures set out in the MDR prior to placing a device on the market. The said regulation also prescribes how competent authorities should address the matters related to products that do not comply with the requirements set forth under the new regulatory framework. In particular, the regulation states that an additional evaluation could be needed in case there are reasonable grounds to suspect that the device could present unacceptable risks or fails to comply with requirements it is subject to in any other way. The present guidance is dedicated to Article 97 MDR, which should be applied when a medical device does not present unacceptable risks but fails to comply with the respective requirements. In particular, the said article applies with respect to medical devices certified under the old regulatory framework set forth under Directive 93/42/EEC (MMD) or Directive 90/385/EEC (AIMDD) used to govern the relationships in the sphere of medical devices before the implementation of MDR to prevent disruptions in their supply and availability on the market. Consequently, the article is intended to provide temporary solutions to be used before the products in question are certified under the new regulatory framework implemented by the MDR. In particular, the MDCG explicitly states that such a solution could be applicable till May 26, 2024.
The purpose of the guidance is to ensure consistency in the application of Article 97 MDR by respective competent authorities with regard to medical devices that are still not certified under the MDR, while the existing certificates issued under the MDD or AIMDD expire before the new certificates are obtained under the MDR.
Under the general rule, if certification of devices under the MDR has not been finalized before the expiry of the Directive’s certificate, and where the device does not present an unacceptable risk to health and safety, Article 97 MDR enables GAs to require the relevant manufacturer, or its authorized 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 CA while limiting as much as possible the impact on the supply of safe and effective devices to patients and healthcare providers. As further explained by the MDCG, the article of the MDR described in detail in the present guidance document is intended to establish a regulatory framework under which medical devices certified under the Directives could be supplied before being certified under the MDR. This becomes especially important since the actual capacity of notified bodies is quite limited due to the limited number of notified bodies designated under the MDR. Therefore, the guidance also outlines the list of documents to be submitted by a party responsible for a medical device in question.
Scope of Applicability
The scope of the present guidance covers the products considered to be legacy devices in accordance with the respective provisions of the MDR. However, the MDCG additionally emphasizes that only the devices in transition fall within the scope of the said regulatory regime – the ones with respect to which a responsible party is taking all the steps to ensure compliance with the new regulatory requirements. Hence, it does not cover the products for which the certificates issued under the Directives have been withdrawn or suspended. Furthermore, the certificate should be valid at its expiry date for the product to be eligible. Moreover, it is also stated that medical devices subject to significant changes also fall outside the scope of applicability of the article described in the guidance.
In summary, the present MDCG guidance describes in detail the approach to be applied with respect to medical devices allowed for marketing and use in the EU, for which the period of validity of the certificates issued under the old regulatory framework set forth by the Directives expires before these devices are certified under the new regime established by the Regulations. In addition, the document clarifies the scope of devices that meet the applicable eligibility criteria and explains the importance of the respective pathway in terms of ensuring the uninterrupted availability of medical devices to healthcare professionals and patients.
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