European Commission Recommendation on Regulatory Exemptions for COVID-19 Products

The European Commission proposed to exempt certain medical devices and personal protective equipment (PPE) urgently required in the current COVID-19 crisis from regular CE marking requirements. Germany and the UK have now followed this recommendation.

Germany and UK Implementations

The European Commission recently published a recommendation for member states that appreciates the challenges that come up for European health systems in the course of the COVID-19 pandemic or Corona virus respectively. 

The recommendation aims to help local country authorities in taking measures to bring critical medical devices and PPE to market quickly. The medical devices directive (MDD) and also the medical devices regulation (MDR) allow for derogations of the CE Marking process when this is deemed necessary by member countries. At the same time, the Commission made clear that no adverse effect on product safety may occur due to a potential derogation.

Against this background, the Commission mentions the following products:

Medical devices:

  • Surgical masks 
  • Exploration gloves
  • Gowns
  • Ventilators

PPE:

  • Face masks
  • Gloves
  • Protective coveralls
  • Protective eyewear 

In addition, European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) have agreed to make important standards that may be used for the manufacturing of these devices freely available. You may access the corresponding article here.

The question now is which countries will follow the recommendation and to which extent these and other products may be exempted from CE Marking. 

Germany exempts certain medical devices and PPE

mdi Europa has learned from a reliable source that the German Federal Ministry of Labor and Social Affairs allows for the following exemptions:

  • Protective eyewear
  • Protective coveralls
  • Single use gloves
  • Surgical masks
  • Face masks

may be placed on the German market without a CE Mark, i.e. without having followed the corresponding conformity assessment procedure if a manufacturer may prove marketability for one or more of the following markets:

  • USA
  • Canada
  • Australia
  • Japan

Please note that these measures will only be valid for the German market and in the context of the pandemic. They are thus timely limited and should not be understood as a general rule.

UK sets up specifications for ventilators

The UK MHRA has issued a notice stating that they will temporarily allow for ventilators and ventilator components to be placed on the market under simplified conditions. However, MHRA made also clear that this possibility will not persist beyond the duration of the current COVID-19 crisis. The corresponding paper (PDF) may be found here.

Germany will allow certain medical devices and PPE to be placed on the market without a CE mark for a limited time.

To summarize, the document provides specifications that must be fulfilled, especially with regards to clinical requirements and usability. If these requirements are fulfilled, products may be placed on the UK market without a CE mark.

Should you have any questions or concerns, please don’t hesitate to get in touch.

Source: Medtech Insight (an Informa product)

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