EC New Regulations in Brief
Both EC amendments are being implemented in order to ensure the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”. Due to the impact of the aforementioned factors associated with the pandemic and the Public Health Emergency announced earlier in February 2020, the actual implementation of the new Medical Device Regulation 2017/745 (MDR) has been postponed. The MDR is intended to replace the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), introducing the new regulatory framework for medical devices placed on the market in the EU. It is also important to mention that the launch of the new EU medical devices database, EUDAMED, has also been postponed. The EUDAMED was designed to improve the exchange with the details related to medical devices, manufacturers, and also other important information associated with the medical devices allowed to be marketed in the EU, including adverse events, safety notices, corrective and preventive actions, recalls and withdrawals.
MDR Notified Bodies: the Issue
According to the MDR, the conformity assessment of the new medical devices should be performed by the Notified Bodies duly designated to review medical devices within the scope of the designation. In order to be designated under the MDR as a Notified Body, an eligible entity shall submit the appropriate application to the designating authority (national regulating authority).
Under the MDR, the Notified Bodies should play an important role in the approval process. The ability of the Notified Bodies to process new applications directly impacts the availability of the new medical devices on the EU market. Nowadays only 14 Notified Bodies have been already designated under the MDR. This creates grounds for reasonable concerns that this number of Notified Bodies would be insufficient to process all applications submitted by the medical device manufacturers in the course of re-certification under the MDR. This could result in delays in the medical devices’ certification process–sometimes leading to the interruptions in supply and thus impacting the availability of medical devices to patients and healthcare professionals.
European Commission Finds a Solution
To reduce the risks associated with the lack of Notified Bodies, the European Commission intends to implement special flexibilities in order to simplify and accelerate the Notified Bodies designation process. As it is stated in the appropriate regulation issued by the EC, the need in such extraordinary measures is also based on the additional restrictions imposed in the EU Member States, such as quarantine regimes and travel restrictions that significantly impact the possibility to carry out the procedures related to the designation process. Under such conditions, the European Commission decided to allow national regulating authorities to apply certain derogations from the Notified Bodies designation procedures and rules set forth by the current regulation in order to ensure the uninterruptable designation renewal process. However, such derogations should not impact the level of public health protection.
New Notified Bodies Designation Process in Detail
The new designation process announced by the European Commission allows to accelerate and simplify the procedures to be carried out in the course of designation renewal, providing that the Notified Body in question remains compliant with any and all applicable requirements. In particular, the new rules are based on the following points:
- The designating authorities should apply special derogations only in cases related to the Notified Bodies previously designated under the Directives.
- The designation renewal granted under the new framework should be temporary and remain valid for a limited period of time – until the exact date the Directives would be fully replaced by the MDR.
- The decision to renew the designation should be based on the rigorous assessment necessary to confirm that the Notified Body in question is still eligible to perform conformity assessment of medical devices within the scope of its designation.
- The designating authority shall review the documents to be provided by the Notified Body applying for the renewal.
- The designating authority shall also develop and implement a set of special extraordinary measures reasonably necessary to perform the surveillance activities the authority is responsible for in spite of additional restrictions imposed due to the COVID-related factors.
- The designating authority shall duly notify the European Commission about any decision to renew the designation, issued under the new framework. When notifying the EC, the designating authority shall provide the information justifying such a decision, accompanying it with the details about the assessment the renewal decision is based on.
Derogations to the Designation Process
Besides the general rules regulating the way the derogations should be applied by the designating authorities and their responsibilities associated thereto, the new regulation also describes in detail the particular derogations the authorities may apply. The new regulation on the Notified Bodies designation process states the following:
- Due to the impact of the COVID-related factors, the designating authority is entitled to renew the designation of the eligible Notified Body without carrying out all procedures required under the general rules, providing that such Notified Body maintains compliance with appliable requirements.
- The designating authority shall make its decision on renewal before the expiration of the initial designation.
- The European Commission may require the designating authority to provide additional information justifying its decision to renew the designation.
- In case if the COVID-related restrictions prevent the designating authority from performing the on-site inspections as required under the general rules, the authority shall carry out other types of assessment reasonably necessary to collect the information sufficient to make a final decision regarding the eligibility of the Notified Body in question for the renewal of the designation. In particular, the scope of the assessment shall cover all aspects related to the organizational structure and other requirements the Notified Body shall meet in order to be able to carry out the conformity assessment of medical devices within the scope of its designation.
Summarizing the information described here above, the new regulation on Notified Bodies designation renewal implements extraordinary and temporary measures allowing to carry out the assessment in spite of the impact of the COVID-related factors and restrictions associated thereto.
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