Regulatory requirements for ventilators and related accessories

Monday, 27 April 2020 14:08 Medical Devices
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 A new guidance on ventilators and related accessories regulated under the Medical Devices Directive 93/42/EEC and on the different options for placing these products on the market.

The guidance has been published by the Medical Device Coordination Group (MDCG) established by Regulation (EU) 2017/745 in April 2020. The MDCG is constituted by representatives of all Member States and it is chaired by a representative of the European Commission.

According to the Medical Devices Directive 93/42/EEC (MDD), devices may be placed on the market and/or put into service only if they comply with its requirements when properly supplied, correctly installed, maintained and used in accordance with their intended use.

The devices have to meet the essential requirements of the MDD, which apply to them, taking into account their intended use. In addition, devices may be placed and circulated on the single market if they have undergone a conformity assessment under the MDD.

Under the current COVID-19 context, the demand for ventilators and their accessories has increased rapidly. Therefore, this guidance aims at outlining the different regulatory options for placing these devices on the EU market, indicating their feasibility to allow short-term supply.

Ventilators are support devices for breathing and can be of different types:
- critical care ventilators
- home healthcare environment ventilators for ventilator-dependent patients
- emergency and transport ventilators
- anaesthetic ventilator.

Ventilators need to be “connected” to the patients through accessories that allow the machine to support the patient’s breathing; therefore, it is important to demonstrate compatibility with the ventilator(s).

 There are different options for placing ventilators on the market:

- Provide parts, components or the finished devices to medical devices manufacturers who currently place ventilators on the market ventilators

As the medical devices sector is highly regulated and complex, leveraging the knowledge and responsibilities of an already established ventilators manufacturer could be the least costly and fastest option to increase the production of ventilators.

 - Derogation procedure - placing on the market authorised by the competent authorities of a Member State in the interest of public health

The timing of obtaining a national derogation from a competent authority will depend on the quality and adequacy of the evidence provided by the manufacturer. When technical documentation and evidence of safe performance is adequate, this can be a feasible option to ensure short-term supply.

 - Manufacturing of the finished device by a producer that was not previously placing on the market ventilators

As the medical devices sector is highly regulated and complex, the scenarios presented below will be the most onerous and therefore only applicable to increase supply in the medium long term.

 

The guidance is available among the Additional Resources of the Medical Devices page.

 

 

 

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