The European Commission (EC), the European authority responsible for medical devices regulation, issued guidance dedicated to medical devices, active implantable medical devices and in vitro diagnostic medical devices in the context of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”.
Basics of Medical Device Regulation
First of all, the guidance provides an overview of the general regulatory approach to different types and classes of medical devices. It is important to mention that providing the definition of medical devices, active implantable medical devices and in vitro diagnostic medical devices the document refers to the Medical Devices Directive 93/42/EEC, Directive on active implantable medical devices 90/385/EEC and the Directive on in vitro diagnostic medical devices 98/79/EC respectively due to the delay in the implementation of the Medical Device Regulation 2017/745 (MDR) the EC announced earlier in March 2020.
The document also describes, in brief, the requirements all medical devices should meet in order to be allowed to be placed on the market. In particular, the EC emphasizes the following core points:
- The manufacturer, the manufacturing process and the device itself should comply with the requirements set forth in the appropriate Directive.
- The particular conformity assessment procedures the device should be subject to depend on the risk class in accordance with the risk-based classification determined on the basis of risk associated with the device.
- Low risk devices could be subject to a simplified procedure. In the case of such devices, the manufacturer issues a declaration of conformity to demonstrate compliance with applicable requirements.
- Medium and high risk devices should be additionally assessed by the special entity (notification body) designated by the national regulating authority to perform an assessment of the certain types of medical devices falling within its scope of designation. The assessment covers such aspects as the quality management system established by the manufacturer and the technical documentation accompanying the device. The list of designated bodies is available on the websites operated by the European Commission.
- The Directives describe the general approach and requirements while the manufacturer may choose the particular technical solution to be used to meet these requirements. When making this choice, the manufacturer should take into consideration the requirements set forth by applicable international standards. All medical devices manufactured in accordance with the appropriate harmonized standard are deemed to comply with the safety and performance requirements. Most of the harmonized standards are based on the ISO and IEC standards. It is important to mention that to improve the availability of the standards during the pandemic, certain standards related to COVID-19 are made available for free while the other standards should be purchased from the national standardization bodies.
COVID-specific Flexibilities and Exclusions
The Directives provide that under certain conditions the Member States may allow marketing of medical devices that haven`t passed the appropriate conformity assessment procedure. Earlier in March 2020, the European Commission has already issued recommendations concerning conformity assessment and market surveillance of medical devices intended to ensure protection against external hazards.
Each national regulating authority is entitled to make its own decision regarding the implementation of certain flexibilities and exclusions aimed at acceleration of procedures necessary to be performed to make critical medical devices, such as ventilators, other respiratory devices or protective equipment available to the healthcare institutions. The decision of the national regulating authority should be based on the rigorous evaluation of the following factors:
- The availability of the substituting products,
- The importance of the particular type of devices under current circumstances,
- The presence of the technical documentation confirming compliance with the requirements set forth by the appropriate Directive,
- Evaluation of tests reports provided by the conformity assessment bodies,
- Data collected in the course of post-marketing surveillance.
It is also explicitly stated that such a waiver should be implemented temporarily and should be valid for the period of time necessary to demonstrate compliance with applicable requirements in accordance with the general procedure or to make substituting devices available on the market. In any case, the manufacturer shall duly inform the regulating authority about placing the device on the market, indicating the information about the registered address and providing a detailed description of the device itself. In case of medical device manufacturers having registered address and principal place of business outside the EU, an authorized representative should be duly appointed in one of the member states to communicate with the regulating authorities.
Additional Requirements for Medical Devices
According to the general rule, the manufacturer shall clearly determine the intended purpose of the device and indicate in labeling, instructions for use and documentation accompanying the device. Thus, any medical device should be used in accordance with the initial intended purpose as indicated by the manufacturer.
At the same time, under certain conditions, it could be necessary to use the device for the purpose other than it was initially intended. This situation is considered “off-label use”. The European Commission warns that off-label use could be associated with the increased risk, so it is necessary to perform an additional assessment of risk and benefits associated with such use. Such assessment should cover the most important aspects including, inter alia, the following ones:
- The assessment of risks associated with the use of the device,
- The analysis of legal implications,
- The description of special measures taken to mitigate the potential risk,
- Additional review of the risk assessment from time to time,
- Applying to the national regulating authorities for approval.
As it was already mentioned before, due to the outbreak of the coronavirus disease, the European Commission suggested postponing the actual implementation of the new Medical Devices Regulation 2017/745 (MDR) for 1 year. The position of the EC is based on the idea that implementation of the new regulatory framework could make the process of making medical devices available on the market more complicated and increase the overall time, that could result in shortages or delays in supply of critical medical devices to the healthcare facilities that is unacceptable due to the increasing demand on medical devices during the pandemic. It is also important to mention that as for now there are only few notified bodies designated under the scope of the new Regulation, so they could be unable to process all requests and applications that could be submitted by the manufacturers of medical devices. Thus, to avoid any delays resulting from potential regulatory issues, the European Commission suggests extending the application of the existing regulatory framework, and the notified designated under the Directives would still be eligible to perform conformity assessment of medical devices.
Summarizing the information provided hereabove, the European Commission provides an overview of both existing regulation and upcoming amendments thereto, and also describes the measures the national regulating authorities could implement to accelerate all compliance procedures related to medical devices facing an increase in demand due to the COVID-19 outbreak.
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