The European Commission (EC), the European authority responsible for medical device regulations, issued recommendations on conformity assessment and market surveillance procedures within the context of the threat associated with the Coronavirus Disease (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”.
COVID-19 Situation Overview and Impact on Medical Devices Industry
The outbreak of COVID-19 that takes place in the EU Member States has already resulted in the exponential growth of demand on certain medical devices, such as surgical masks. This creates an additional overload of the existing supply chains that are also being impacted by the restrictions related to the infection. Under such conditions, the EC has to implement all measures necessary to ensure the interruptible access to the appropriate medical devices and personal protective equipment.
To address the factors described hereabove, the manufacturers of medical devices have to take additional steps to meet the growing demand they face. In particular, they have already commenced creating new production sites and redesigning existing supply chains.
The scope of the document covers both disposable and reusable face masks regulated as personal protective devices under Regulation 2016/425, and also the surgical masks, examination gloves, and some other products regulated as Class I non-invasive medical devices. The particular requirements applicable to medical devices are set forth by the Directive 93/42/EEC, repealed by the Medical Devices Regulation 2017/745 (MDR), that enters into force on May 26, 2020. These products are essential when combating the COVID-19 threat. Both regulations mentioned hereabove contain the full set of requirements regarding the way the appropriate products should be designed, manufactured and placed on the EU market. Thus, the products that comply with these requirements are allowed to be marketed and the Member States could not introduce additional restrictions and limitations.
Placing Medical Devices on the EU Market
The document describes in detail the requirements the manufacturers should fulfill and the procedures they should pass in order to be allowed to place their medical devices and PPE on the EU market. Depending on the particular product subject to review the requirements would be the following:
- According to the Directive and Regulation, the manufacturer shall perform the conformity assessment procedure to demonstrate compliance with applicable safety and performance requirements. Upon demonstrating compliance, the manufacturer would be allowed to affix the CE marking as a confirmation and to place the device on the EU market. Both directive and regulation do not set forth specific requirements regarding the particular technological solutions to be used, they only establish the general principles all medical devices should be based on. At the same time, another aspect medical device manufacturers should take into consideration is the compliance with the applicable harmonized standards. Each technical solution utilized by the manufacturer should be actually performed in a way that meets the requirements provided by the appropriate standard. In accordance with the requirements applicable to Class I medical devices, conformity assessment could be performed by the manufacturer itself without the involvement of an independent conformity assessment body.
- According to Regulation 2016/425, personal protective equipment should be also subject to conformity assessment procedures related to compliance with the safety requirements in order to be allowed to be placed on the EU market. PPE should be also duly affixed with the CE marking. The aforementioned regulation also describes essential technical requirements the personal protective equipment should meet. It is also important to mention that some of the PPE devices should pass special conformity assessment procedures – for example, such procedures would be mandatory for Category III devices (e.g. PPE designed to protect against harmful biological agents). In such cases, an independent conformity assessment body should be involved.
Notified bodies are the special independent entities duly designated by the national regulating authorities to perform the conformity assessment procedures within the scope of designation. In order to meet the eligibility criteria, notified bodies shall employ the appropriate number of qualified experts with the appropriate background and experience. Notified bodies are entitled to carry out the compliance assessment and issue certificate confirming the compliance of the products subject to review with applicable safety and performance requirements. Notified bodies are also obliged to inform both national regulating authorities and other notified bodies about the certificates issued. Such information exchange is also important for other notified bodies performing the assessment of other medical products manufactured in compliance with the same essential safety and performance requirements.
In case if the national regulating authority would detect a PPE product without the CE marking, it would require performing a conformity assessment procedure to assess the compliance with applicable safety and performance requirements. In case if compliance would be confirmed, the product should be affixed with the CE marking, while in case of non-compliance the authority is entitled to require the manufacturer of the product to implement appropriate corrective actions or to withdraw the product from the market. When performing such procedures, the national regulating authority would also duly inform the European Commission and national regulating authorities of other Member States about the assessment results and actions to be taken by the manufacturer.
Disease-Specific Requirements on Marketing Medical Products
Notwithstanding the requirements described hereabove, some specific rules should be applied due to the threat caused by COVID-19. In particular, there are simplified procedures allowing to accelerate placing the medical devices and PPE products meeting high demand on the market.
In the case of non-CE marked PPE products intended to be marketed in the European Union, the initial assessment could be performed by market surveillance authorities that would evaluate whether the product complies with applicable safety requirements. If the compliance would be confirmed, the manufacturer would be allowed to place the product on the EU market for a limited period of time within which the appropriate notified body shall perform the conformity assessment. It is also important to mention that in such cases the market surveillance authority would also properly inform the respective authorities of other Member States to ensure that the product would be available within the whole territory of the EU.
Due to the fact that some of the medical devices and PPE products facing increasing demand during the COVID-19 pandemic, the authorities should take all steps necessary to ensure that all medical devices and PPE products allowed to be used within the EU in accordance with the accelerated procedure described hereabove are available only to healthcare professionals, while unauthorized use of non-CE marked products should be avoided. The assessment of such devices and products could be also performed in the course of the initial purchase process providing that they would be supplied only via the especially determined channels and would not be available through the regular way of distribution.
During the COVID-19 outbreak, the notified bodies performing conformity assessment should focus on medical devices and PPE products that are the most important due to the disease, and all procedures related to such devices and products should be performed swiftly and without any undue delays. Member States are also entitled to adopt certain derogations from the conformity assessment procedures performed without engaging the notified body.
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