The article provides an overview of the new guidance document issued by the MDCG about surveillance in the context of MDR transitional provisions.
Table of Contents
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to appropriate surveillance regarding the transitional provisions under Article 120 of the Medical Device Regulation 2017/745 (MDR) about devices covered by certificates according to the previous Directives (Medical Devices Directive or Active Implantable Medical Devices Directive) replaced by the MDR. It is important to mention that the present guidance should not be construed as issued by the European Commission, nor as a legally binding document that establishes new rules or requirements. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto.
Regulatory Background
According to article 120(2) and 120(3) of the MDR, devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions.
For the said procedure to be applied, the notified body should continue performing its functions about a medical device in question, including post-market surveillance. Hence, it is important to ensure that all the parties involved are aligned concerning the scope of activities the post-market surveillance includes.
The guidance also refers to the concept of a “legacy device” which stands for a medical device placed on the market after the new regulatory framework has entered into force while the device itself is covered by the certificates issued under the previous framework.
As further explained by the MDCG, the scope of the document covers the activities to be carried out by notified bodies in the context of post-market surveillance as prescribed by the new Regulation. Apart from this, the guidance provides additional clarifications regarding the corresponding obligations of medical device manufacturers, including the ones related to the quality management system to be duly developed and implemented by the latter to ensure consistency in the quality of products they are responsible for. It is important to mention that the recommendations provided in the document apply to any notified bodies entitled to issue certificates under the Directives, irrespectively of whether they are designated to do so under the new Regulation. The MDCG also states that the aspects related to the In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR) are falling outside the scope of the present guidance. However, some of the principles outlined in the document could be applicable concerning IVD products as well.
QMS Requirements
First of all, the document provides an overview of the applicable regulatory requirements related to the manufacturer’s quality management system and obligations associated thereto. According to the applicable regulation, a medical device could be made available for customers under the Directives provided there were no changes to the product from the date it was certified (the above applies to significant changes to the design of the device or its intended purpose as set forth by the manufacturer). Hence, the manufacturers should merely maintain the QMS implemented under the Directives. At the same time, the manufacturer should also ensure compliance with any applicable requirements set forth by the new Regulation, especially the ones related to post-market surveillance. It is important to mention that because EUDAMED, the new EU-wide database for medical devices, is not fully operational yet, national regulatory requirements related to product registration should be applied.
The specific requirements a medical device should be subject to are to be determined based on its class under the applicable risk-based classification. According to the guidance, the requirements to be applied concerning active implantable medical devices should be the same as the ones for Class III medical devices. Moreover, medical device manufacturers should also prepare periodic safety reports as prescribed by Article 86 of the new Regulation. Such reports should be provided upon request of the respective regulating authorities.
The MDCG explicitly states that MDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to “legacy devices”. The agency further provides a few examples of the provisions that should not be applied. Hence, the manufacturers are encouraged to follow other requirements set forth by the new Regulation, but are not obliged to do so concerning “legacy devices”. To assist medical device manufacturers in interpreting the applicable regulatory requirements, the guidance further provides a comparison of the requirements set forth by both Directives and the Regulation.
Surveillance-Related Requirements
The scope of the guidance also covers the aspects related to post-market surveillance and regulatory requirements associated thereto. As it was mentioned before, a notified body should continue performing its post-market surveillance functions for medical devices placed on the market under the Directives. In this respect, they should consider the requirements set forth by the transitional provisions. As it is mentioned by the MDCG, following the information by the manufacturer, the notified body needs to identify which of the existing MDD or AIMDD certificates will continue to be used and if their scopes remain unchanged. It is further explained that the agreements concluded between medical device manufacturers and notified bodies should cover the aspects related to post-market surveillance and actions to be performed by notified bodies in this respect during the whole transition period which will last till May 26, 2024.
As it was mentioned before, medical devices for which the certificates have been issued under the Directives could still be placed on the market provided no significant changes were impacting their safety and/or performance. According to the guidance, a notified body should ensure that this is the case. Should the manufacturer introduce changes to the quality management system, the appropriate change control requirements should be followed. The manufacturers may also introduce changes to achieve compliance with the requirements set forth under the new Regulations, and such changes should be duly validated.
In summary, the present MDCG guidance provides an overview of the applicable regulatory framework for medical devices placed on the market under the Regulation while having certificates issued under the Directives. The document highlights the most important aspects to be considered in this regard, including the responsibilities of medical device manufacturers and notified bodies.
Sources:
https://www.salute.gov.it/imgs/C_17_notizie_5849_0_file.pdf
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
