Regulatory Background
The present MDCG guidance is dedicated to ventilators and accessories thereto as medical devices widely used in the context of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus”. The outbreak of the COVID-19 resulted in a significant increase in demand on the aforementioned medical devices due to the complications and respiratory illnesses caused by the disease. Nowadays the devices covered by the scope of the guidance are being regulated under the Medical Devices Directive 93/42/EEC (MDD), which later would be superseded by the Medical Device Regulation 2017/745 (MDR) that due to the certain issues would become effective a year later than initially intended.
In accordance with the aforementioned Directive, a medical device could be marketed or used only in case if it meets any and all safety and performance requirements set forth therein. The particular requirements to be applied depending on the intended purpose of the device and its class according to the risk-based classification. The device should also pass the appropriate conformity assessment procedure.
The new MDCG guidance is intended to implement additional extraordinary measures reasonably necessary to avoid shortages and ensure the availability of ventilators and accessories thereto during the pandemic since the devices of this type are vitally important for treating patients with respiratory disorders. The document implements new rules and requirements allowing to reduce the time needed to place ventilators on the EU market by reducing the regulatory burden on medical device manufacturers and other parties involved in operations with medical devices.
Ventilators: Regulatory Approach
First of all, the document provides the description of medical devices covered by its scope and their classification based on the intended purpose. Depending on these criteria, ventilators could be divided into the following categories:
- Critical care ventilators used to perform ventilation of the lungs being connected to the airway of the patient. The devices of this category are intended to be used in the clinical environment (in healthcare facilities) being operated by qualified healthcare professionals. Such devices could be used for patients with life-threatening conditions or ones being ventilator-dependent.
- Home-use ventilators intended for ventilator-dependent patients – special devices intended to be used in case the patient requires mandatory ventilation while being at home. Under certain conditions, the devices of this type could be used in the clinical environment.
- Transport and emergency ventilators – portable devices intended to be used when transporting the patient. The devices of this type should have an advanced alarm system notifying healthcare professionals of any malfunctions that could occur.
- Anesthetic ventilators – the devices intended to be used during anesthesia.
The main distinguishing feature of the critical care ventilators is the invasive type of connection providing that such a device should be connected through the tracheal intubation. At the same time, most of the devices of such type could be also connected using non-invasive ventilation methods (via a facemask).
According to the MDCG guidance, depending on the model, ventilators could also have supplementary functions, such as:
- High flow oxygen supply,
- Monitoring systems,
- Nebulisation systems.
Ventilators` Accessories and Components
Due to the specific construction, additional accessories are needed to connect the ventilator to the patient. The main criterion applicable to accessories is compatibility since sometimes accessories could be placed on the market separately, for example:
- Breathing systems and circuits (including tubes, connections, and masks),
- Humidifiers and filters associated thereto,
- Nebulizers,
- Special accessories for monitoring and notifying the operator when necessary.
Some of the accessories contain patient-contacting elements or components contacting a patient`s breath – such devices should be either disposable or reusable.
Other elements of ventilators that could not be considered as separate accessories should be subject to regulation together with the device itself.
EU Classification of Ventilators
The present MDCG guidance provides a detailed description of the classification used for ventilators and accessories thereto. In particular, the approach used to classify ventilators is based on whether the device is invasive or not, or the environment the device is designed to be used in.
According to the classification set forth by the MDD, the following rules should be applied:
- Non-invasive ventilators, that are not intended for critical care are Class IIa medical devices;
- All other ventilators are Class IIb medical devices.
Thus, the particular class the ventilator in question should be assigned to depends on its intended purpose, while the conformity procedure the device should be subject to depends on the risk class respectively.
Accessories for ventilators that are regulated as independent medical devices could be Class I, IIa, or IIb medical devices.
Due to the classes under the risk-based classification mentioned here above, all ventilators and accessories thereto require the involvement of a notified body to perform the appropriate conformity assessment procedure in order to be allowed to be placed on the market.
Special COVID-related Regulatory Measures
The MDCG recognizes the necessity of the special regulatory measures to be implemented to expand the availability of ventilators and accessories during the pandemic when new entities make attempts to manufacture ventilators to meet the increasing demand for devices of this type. In particular, the document describes certain measures to be taken to address the aforementioned issues, namely:
- Providing the manufacturers of ventilators with all necessary parts and components. In case if the manufacturer is duly authorized to produce ventilators and place them on the market, it is allowed to use components produced by other entities. According to the position of the MDCG, this approach could be the most efficient one in expanding the availability of ventilators on the EU medical devices market. At the same time, the manufacturer would be responsible for controlling the quality of the parts and components supplied. The manufacturer shall also duly inform the notified body about each new supplier. Under certain conditions, medical device manufacturers could subcontract the manufacturing of ventilators as the entire device. In such a case, the manufacturer shall provide its third-party subcontractor with all necessary documentation and specifications while remaining responsible for the device manufactured in the course of such cooperation.
- Derogations. In case if the national regulating authority of one Members of the States finds it necessary, it is entitled to apply national derogations – a special framework allowing to place the device on the market before completing all conformity assessment procedures required under the general regulation. At the same time, the device should be meet all applicable safety requirements to avoid exposing the patients` health to additional risk. The national authority providing such temporary approval should also notify the European Commission and other national regulating authorities about such approval, including the information about the scope of devices it covers.
- Producing ventilators by the manufacturer that has not been previously engaged in producing such medical devices. In this case, all basic requirements for the medical device manufacturer should be applied.
Summarizing the information provided here above, the present MDCG guidance describes in detail the way existing regulations should be applied in order to ensure and expand the availability of ventilators and accessories thereto during the pandemic.
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Sources:
https://ec.europa.eu/docsroom/documents/40941?locale=en
