The new article outlines considerations related to the activities carried out by notified bodies concerning medical devices intended to be marketed and used in the EU.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework, has published a position paper dedicated to transitioning from the old regulations (Directives) to the new ones: the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR). In particular, the document addresses the aspects related to the capacity of notified bodies designated to conduct conformity assessment activities, and also the availability of medical devices and IVDs. The document provides additional clarifications and recommendations to be taken into consideration by all the parties involved. At the same time, provisions of the document are non-binding, and should not be construed as an official position of the European Commission.
First of all, the MDCG acknowledges the challenges arising from the current changes in the existing regulatory framework for medical devices. For instance, it is vitally important to ensure the notified bodies designated under the new Regulations have sufficient capacity to process all the requests related to medical devices, otherwise, this could potentially result in shortages and interruptions in supply, impacting adversely the availability of medical devices for healthcare professionals and patients. According to the information currently available to the MDCG, such issues have already taken place, so additional measures are to be implemented to avoid this in the future. Health Ministers have already raised this question before the MDCG and requested for such measures to be developed. As explained by the MDCG, the proposed actions outlined in the document are intended to improve the efficiency of the application of the regulatory requirements, rather than reducing, avoiding, or removing requirements, in particular about safety.
In particular, the actions outlined in the document are intended to enhance the capacity of notified bodies to facilitate and streamline the transition to the new regulatory framework while preventing shortages in the supply of medical devices. These actions are expected to be implemented by the MDCG promptly, while the Group would also perform continuous monitoring of the implantation process and analyze the progress. At the same time, the MDCG additionally emphasizes the importance of cooperation of all the parties involved to ensure the effectiveness of the said actions.
The actions described in the present position paper are mostly related to the MDR, however, most of them could be applied to IVDR as well. The MDCG also reserves the right to add more actions, should it be reasonably necessary to achieve the goals.
Increasing Capacity of Notified Bodies
The first set of actions described in the document is intended to increase the capacity of notified bodies. For this purpose, the following actions are to be taken:
- Notified bodies are encouraged to use hybrid audits.
- MDCG also recommends notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted about requirements under the Directives to be used in the course of conformity assessment under the Regulations. In such a way, unnecessary duplication of work could be avoided. However, for this approach to be applicable, the evidence used should be of the proper quality.
- Combining the audits under both Directives and Regulations for legacy devices while paying attention to compliance with the Regulation. The MDCG further mentions its intent to develop a separate guidance document dedicated to the matters related to surveillance.
- The MDCG also intends to review its guidance to make sure the administrative workload for notified bodies is reduced to a reasonable extent.
- Since the new EU-wide database for medical devices, Eudamed, is already under development, at some point in time notified bodies will be able to upload the information machine-to-machine, while double registrations should be avoided when possible.
- Notified bodies are encouraged to take the steps intended to increase their capacity including, inter alia, additional training, coaching, and internships for the staff. Apart from this, notified bodies should reconsider internal procedures to ensure their efficiency.
- A new Commission Delegated Acts is expected to modify the frequency of complete re-assessment of notified bodies. According to the existing regulations, a reassessment should be conducted 3 years after the initial designation of a notified body, and once in 4 years thereafter. The new approach provides additional flexibility allowing for the allocation of the review resources to new applications. This will also allow existing notified bodies to focus on their conformity assessment activities instead of reassessment audits.
- All the parties involved in the assessment and designation of notified bodies are encouraged to take all the steps necessary to accelerate the processes and procedures associated thereto while ensuring compliance with any requirements to be applied concerning conformity assessment bodies.
- The MDCG would also search for ways to expedite the process of adding codes to the designation of notified bodies.
- The MDCG will also prioritize the actions related to the review of guidelines and recommendations in the sphere of notified bodies, their assessment, and designation.
- The parties involved in the regulatory processes described herein should have sufficient flexibility when demonstrating compliance with the applicable regulatory requirements. Furthermore, new guidance documents introduced should not impact ongoing activities.
Apart from the actions described hereinabove, the document also outlines additional actions to be taken to improve access to notified bodies and increase the preparedness of manufacturers, as well as other actions facilitating the transition to the new regulatory framework set forth by the Regulations intended to prevent delays.
In summary, the present MDCG guidance describes the issues related to the lack of notified bodies designated under the Regulations and the impact this situation could potentially have on the availability of medical devices on the EU market. The document also suggests the steps to be taken to address this issue and make all the regulatory procedures related to the assessment and designation of notified bodies more efficient.
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